Microbioz India, August 2023 Lab edition

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Microbioz India, August 2023 | 6 64 12 10 45 22 10 18 Cover Story The Science of Drug analysis: All you need to know Featured Article Introducing the DVS Carbon: A Revolutionary Advancement in CO2 Capture Research Business News NIH and Exothera collaborate to produce GMP intranasal vaccine against SARS-CoV2 for clinical phase I/II trial in Africa and US Product Launches How to improve the reproducibility of your flow chemistry 10 22 34 45

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Microbioz India, August 2023 | 8 Disclaimer: Neither the Microbioz India nor its publishers nor anyone else involved in creating, producing or delivering the Microbioz India (in printed, web or CD format) or the materials contained therein, assumes any liability or responsibility for the accuracy, completeness, or usefulness of any information provided in the Microbioz India Magazine (in printed, web or CD format), nor shall they be liable for any direct, indirect, incidental, special, consequential or punitive damages arising out of the use of the Microbioz India magazine. he fields of drug analysis encompasses various components, such as the identification of new medications, evaluation of their binding affinity and selectivity, characterization of their molecular structures, and assessment of their efficacy through in vitro and in vivo experiments. The Science of Drug Analysis: All you need to know is this month's cover story, contributed by Microbioz India editorial. The application of nuclear magnetic resonance (NMR) spectroscopy is extensively employed in the screening of new pharmacological compounds as well as in investigations related to structural analysis and binding interactions. In industrial applications, the substantial expenses associated with NMR equipment necessitate the implementation of acceleration solutions to enhance throughput for large-scale drug screening. Specifically, in the context of efficiency testing, the desired level of high throughput has yet to be achieved. Hence, nuclear magnetic resonance (NMR) is typically not utilized in such tests. Magnetic resonance imaging (MRI) facilitates in vivo examinations in both animal models and human subjects. This issue's interview-based featured article, "Flow Chemistry Innovations," is an interview-based featured article authored by Steve Evans, the Chief Commercial Officer at Uniqsis. Despite its many benefits, transitioning from batch methods for the synthesis of chemical entities to continuous flow protocols based on microreactors still varies in different parts of the world and from industry to industry. The flow chemistry approach, which has been widely adopted by pharmaceutical scientists and production engineers in recent years, perhaps shows a glimpse of the future. Uniqsis is a manufacturer of entry-level and fully integrated continuous flow reactors designed by chemists for chemists. Dear subscribers, there is nothing better than having your constructive criticism and recommendations because they enable us to consistently produce far better content. Please send an email to [email protected] if you have any recommendations or comments.

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Microbioz India, August 2023 | 10 The Science of Drug Analysis: All you need to know he field of drug analysis encompasses various components, such as the identification of new medications, evaluation of their binding affinity and selectivity, characterization of their molecular structures, and assessment of their efficacy through in vitro and in vivo experiments. The application of nuclear magnetic resonance (NMR) spectroscopy is extensively employed in the screening of new pharmacological compounds, as well as in investigations related to structural analysis and binding interactions. In industrial applications, the substantial expenses associated with NMR equipment necessitate the implementation of acceleration solutions to enhance throughput for large-scale drug screening. Specifically, in the context of efficiency testing, the desired level of high throughput has yet to be achieved. Hence, Nuclear Magnetic Resonance (NMR) is typically not utilized in such tests. Magnetic resonance imaging (MRI) facilitates in vivo examinations in both animal models and human subjects. While magnetic resonance imaging (MRI) is commonly employed for the purpose of monitoring disease development in patients, its utilization for medication evaluation purposes is hardly observed. Instrumental methods are often used to analyze chemicals in bulk and in pharmaceutical forms and to study how stable they are. Their sensitivity, methods, and the chemicals they use are all different. This part will give an overview of these different methods and how they can be used. It will also explain how to build and create simple, sensitive, and accurate methods for routine quality control of a certain compound based on its molecular structure. The analytical method will be talked about in terms of quality control and assurance. Methods that are often used to test drugs The composition, physical and chemical properties, legitimacy, purity, and amount of active ingredients in a drug can be studied through pharmaceutical analysis and testing. T Cover Story

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Microbioz India, August 2023 | 12 This makes sure that people can use drugs safely and effectively. Before you can analyze drugs, you need to have the right testing equipment and other tools, which are the foundation of drug quality testing. Method of instrument study Instrumental analysis is used for high-sensitivity micro and trace research. It mostly includes the visual method, the electrochemical method, chromatography, electrophoresis, the enzymatic method, and the immune method. Use of chemicals Gravimetric and titration methods are both types of chemical methods. Gravimetric method means separating the substance or chemical that is related to the component to be tested. The mass of the component is then used to figure out how much of the component there is. Gravimetric method is used to measure both chondroitin sulfate and the amount of fat in pancreatic enzymes. Titration is the process of figuring out the amount of a material based on how much of a standard solution is used. At the moment, the titration method is used to figure out how much amino acid and sugar a drug has. Bioassays This is a way to measure how a drug affects a living thing or a part that has been taken out of the body. It can be used to check drugs for impurities, find out how dangerous they are, and figure out their titers. The test method is usually very close to how drugs work and how well they work, and the results are usually easy to understand. But the use of a big number of animals, the complexity of the experiment, and other factors all make the results less accurate. The following are typical Analytical approaches to drug analysis: Gravimetric analysis Gravimetric analysis is a quantitative analytical technique used in various scientific disciplines to determine the amount of a particular substance present in a Gravimetric analysis serves as the fundamental chemical technique employed in the examination and testing of pharmaceutical substances. The term "it" pertains to the process of acquiring a specific weight of a sample, employing a suitable technique to isolate the measured component from other constituents within the sample, subsequently transforming it into a specific form for weighing, and ultimately determining the quantity of said component. Cover Story

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Microbioz India, August 2023 | 14 Acid-base titration The process of acid-base titration involves the controlled addition of a reagent solution, whose concentration is accurately determined, into a solution containing the drug under investigation. This addition continues until the chemical interaction between the reagent and the substance being evaluated reaches completion. The determination of the measured component's content can be achieved by researchers by the manipulation of the concentration and volume of the reagent solution employed. Acid-base titration is a commonly employed chemical analysis technique in practical manufacturing processes. PH value determination method The pH of a solution is defined as the negative logarithm of the hydrogen ion activity, and it serves as a measure of the solution's acidity. The instrument employed for the determination of pH is commonly referred to as a pH meter or acidity meter. This apparatus comprises two essential components, namely a pH measurement electrode and a pH indicator. Spectroscopy Spectroscopy is a scientific technique that involves the study and analysis of the interaction between The fundamental tenet behind spectroscopic technology is that the drug under examination can be subjected to radiation across several frequencies. When certain compounds are exposed to frequencies within a specific range, they undergo vibration and rotation. Upon the completion of data recording, specifically pertaining to the measurement of wavelength, the resultant outcome will be the acquisition of the spectrum. Chemiluminescence Chemiluminescence technology refers to a scientific method that involves the emission of light as a result of a chemical reaction. The chemiluminescence method is frequently employed in drug analysis and detection. This technical approach relies on the principle that there exists a linear quantitative relationship between the concentration of the substances being detected within the chemical detection system and the intensity of chemiluminescence exhibited by the system. This relationship is observed under specific conditions. Chromatography Chromatography is a widely used analytical technique in the field of chemistry. It is Chromatography, referred to as "chromatographic analysis" in academic circles, is a technique employed for the purpose of separation and analysis. The separation process primarily relies on the selective distribution of various substances across distinct phases. Elution is performed by the mobile phase present in the stationary phase, causing the different substances in the mixture to move at varying velocities, ultimately resulting in separation. Electrophoresis Electrophoresis is a laboratory technique used to separate and analyze charged molecules, such as Electrophoresis is a crucial technique utilized in the fields of biotechnology and biochemical drug analysis. The aforementioned technique possesses several merits, including heightened sensitivity, excellent reproducibility, a broad spectrum of detectable substances, and straightforward operational procedures. DNA amplification The process of DNA amplification refers to the replication of a certain DNA sequence in vitro, resulting in an increased number of copies of DNA amplification technology, specifically polymerase chain reaction (PCR) technology, enables the exponential amplification of DNA fragments within test tubes, resulting in a millionfold increase in quantity. This amplified DNA can be visually seen without the need for specialized equipment. Cover Story

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Microbioz India, August 2023 | 16 Flow chemistry innovations An interview with Steve Evans* of Uniqsis espite its many benefits, transitioning synthesis of chemical entities by batch methods to continuous flow protocols based on microreactors still varies in different parts of the world and from industry to industry. The flow chemistry approach, which has been widely adopted by pharmaceutical scientists and production engineers in recent years, perhaps shows a glimpse of the future. Uniqsis is a manufacturer of entry-level and fully integrated continuous flow reactors designed by chemists for chemists. Here's a fascinating interview I had with Steve Evans, the Chief Commercial Officer at Uniqsis. Please tell us about Uniqsis and its specialisation in flow chemistry? Since our formation in 2007 we’ve been committed to developing innovative flow chemistry products for customers across the chemical and pharmaceutical research sectors. A good example of this is our FlowSyn range of fully integrated flow reactors which has become the flow chemistry tool of choice for many research chemists across the world. Our aim over the last 15+ years has been to make flow chemistry easily accessible to both novices and experienced users and to provide expert technical and applications support to our growing user base in Europe, North America and across Asia. To enable chemists to realise the many benefits of using photochemical methods in synthetic chemistry, Uniqsis has in the last few years developed an exciting range of high-performance flow and batch photochemical reactors. Caption: Uniqsis at ChemExpo India exhibition Why should Indian labs consider switching from batch to flow chemistry? For many years – research chemists heavily relied on well-established batch synthesis techniques based upon technology that had remained relatively unchanged for decades. Starting from the petrochemical industry the many benefits of implementing a continuous flow chemistry reactor have become increasingly evident to chemical researchers worldwide. These benefits include: 1. Reactions can be run faster by superheating reagents under pressure. 2. Reactions can be run much more safely and reproducibly as smaller volumes per unit time are run compared to equivalent conventional batch methods. 3. Flow Chemistry is much easier to scale up to generate larger quantities once optimum conditions have been established in smaller scale reactions. 4. Flow chemistry uses less energy and creates less waste – consequently it is a greener technique plus it reduces costs. These undisputed flow chemistry benefits facilitate bringing a product faster to market by cutting down the number of reaction steps, increasing product yields and reducing required downstream purification/processing. D Our aim over the last 15+ years has been to make flow chemistry easily accessible to both novices and experienced users and to provide expert technical and applications support to our growing user base in Europe, North America and across Asia. “ Interview

Microbioz India, August 2023 | 17 Flow chemistry has also enabled research chemists to gain the full benefit of chemistries previously not possible using conventional batch technologies. What advantages does photochemistry offer synthetic chemists and what products does Uniqsis offer in this area? Many chemical processes benefit from the interaction of light at various wavelengths to initiate and drive a reaction. This is particularly relevant for flow processes where the penetration depth of the light is generally much lower than in a batch process, hence much more efficient. Uniqsis has developed a series of flow photoreactors operating at optimum wavelengths to cover a wide range of synthetic chemistry methods performed at different scales (mg to kg). Our Borealis range of flow photoreactors are an excellent tool for reaction optimisation on a smaller scale. The photochemical reaction, once optimised on the Borealis can then be scaled up using a PhotoSyn flow photoreactor. The PhotoSyn is a totally unique reactor comprising of 2 semi-circular LED arrays focused on a coil reactor. The PhotoSyn offers unrivalled power to efficiently and safely facilitate scale up. Caption: Borealis photoreactor Why is efficient mixing important in flow chemistry and how is it best achieved? To achieve high reproducibility and facilitate scaleup the control of mixing and temperature is essential. Efficient mixing is particularly important for highly exothermic or fast, mixing-dependent reactions. Using glass static mixer (GSM) chips or reactor blocks have become a widely trusted method for producing an efficient, turbulent mixed reagent stream that is not diffusion dependent. Our glass static mixers can be used as mixing modules prior to a coil reactor residence time unit, or as reactor blocks suitable for rapid exothermic reactions including metalation and nitration. Reagent input streams run through the tempering channels of the GSM to equilibrate temperatures prior to merging at the mixing point. These 'chips' are precision machined from inert borosilicate glass to withstand a wide temperature range and can be conveniently attached to our FlowSyn column heater module or on top of either the Cold Coil and Polar Bear Plus cryogenic reactor modules. Connections to a GSM chip can be conveniently made using standard threaded HPLC fittings utilising an 'O'-ring seal to ensure effective fingertight sealing without the need for any tools. Caption: Glass Static Mixer chips improve flow chemistry reproducibility Industrial labs are often looking for ways to increase productivity - what Flow chemistry automation innovations have Uniqsis developed? We have developed an Auto Loop Filling system which enables pharmaceutical chemists to run combinatorial flow library synthesis and optimisation in an unattended fashion freeing up valuable time to perform other tasks. Using such a system - chemists can run up to 100 independent optimization experiments by automatically filling sample loops with the different reagents in many different combinations in a 2 or 4 reagent channel flow chemistry reactor configuration. Using an Auto Loop Filling system is easy. You simply set up the required automated reaction protocols and leave the system to do the rest. Interview

Microbioz India, August 2023 | 18 Caption: FlowSyn Auto LF II™ for Automated Synthesis How does Uniqsis support its flow chemistry systems in India? For several years - Ultra Instruments Pvt has been our knowledgeable local agent supporting our expanding Flow Chemistry business activities in India. Ultra have offices located in many parts of India and they have staff trained to offer comprehensive pre-sales and post-sales support for our complete range of products. Indian customers also have access to technical and application support advice from world leading flow chemistry experts based at Uniqsis HQ in the UK. About Steve Evans: Steve Evans is the Chief Commercial Officer at Uniqsis. He has a wealth of experience in flow chemistry having previously held a number of commercial positions including sales, account development/management, sales team/distributor management, product/business development, global sales & marketing management in the industry. Steve has a BSc in chemistry. Interview

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Microbioz India, August 2023 | 20 Metals Analysis in Pharmaceutical Goods harmaceutical element analysis and trace metals testing are crucial for medication product quality management and commercial release. Understanding the elemental composition of your raw materials, active pharmaceutical ingredients (APIs), excipients, or formulations aids in the quality and purity of your product. When the elemental composition is unknown, a strategic strategy is essential to rationalize effort and expense. Trace metals are hazardous and can impair formulation stability and catalyst degradation. As a result, control during the manufacturing process is critical. The presence of trace species at extremely low quantities, as well as materials with low solubility, can all provide analytical obstacles to elemental analysis. The ICH Q3D guidelines have now been revised and implemented, with the correction of Permissible Daily Exposures (PDEs) for gold (updates to oral, parenteral, and inhalant PDEs), silver (updates to parenteral and inhalant PDEs) and nickel (update to inhalant PDE only) as well as the correction of gold and silver monographs. Furthermore, limits have been added for elemental impurities by the Cutaneous and Transcutaneous administration route. Update of ICH Q3D Trace metals in pharmaceuticals Trace metal impurities, originating from raw materials or production processes, pose risks to human health as well as the quality and efficacy of pharmaceutical products. Regulatory guidelines require the specific quantitative analysis of pharmaceutical products – primarily utilising inductively coupled plasma techniques such as ICP-MS. These analytical techniques require frequent calibration and may also require spike and recovery tests, and reference standards for control samples. In addition, traceable standards are necessary for IQ/OQ reports. ICH Q3D Guidelines, USP <232> and USP <233> have been in routine use for many manufacturers and distributors of pharmaceuticals and related products. The allowed Permissible Daily Exposure (PDE) is specific to each impurity metal. Concentrations for calibration and spikes in the analytical run are determined by a calculated J-value (see Figure 1), as in the example shown. P Featured Article

Microbioz India, August 2023 | 21 ICH Q3D (R2) The ICH Q3D guidelines have now been revised and implemented, with the correction of PDEs for gold (updates to oral, parenteral, and inhalant PDEs), silver (updates to parenteral and inhalant PDEs) and nickel (update to inhalant PDE only) as well as the correction of gold and silver monographs. Furthermore, limits have been added for elemental impurities by the Cutaneous and Transcutaneous administration route. Certified Reference Materials to Support Your Analysis LGC Standards ICH-USP Certified Reference Materials (CRMs) can greatly simplify the calculations needed to achieve method conformance for the widest range of analytes in a given sample because we have configured the stock concentrations according to specified PDE. LGC CRMs are at concentrations that allow a simple dilution to meet the required J value for any product. This allows for the greatest degree of efficiency of each analysis, reduction in the potential labor of sample preparation and elimination of the often-complicated calculations involved when using single element CRMs. Oral and Parenteral administration routes have unique PDE values according to the method, thus we have certified reference materials available for each supporting both revision 1 (R1) and revision 2 (R2) of ICH Q3D. For ICP-MS, proper choice of an internal standard is also critical to success. Use of internal standards with the ICP-MS technique is different than those employed with familiar liquid chromatography (LC) methods. Internal standard elements are chosen for (a) mass proximity to analytes, (b) suitably matched ionization to each analyte, especially for low ionization elements such as arsenic (As). LGC Standards have optimized multi-element products for internal standard implementation, well suited across the range of available ICP-MS instrument commercial brands. Single element internal standard stock CRM are also available for a wide range of elements. Kits for ICH (R1 and R2) / USP Methods are available that are concentration-matched for both Oral and Parenteral type sample groups. These kits bundle the necessary CRM products required for the particular sample group that applies. Custom blends of nearly any configuration can also be provided; as well, to meet unique needs based on analyte, concentration or blend arrangement. Please contact one of our offices to inquire about custom CRM to meet your needs. All products are prepared from high purity raw materials, high grades of acids and 18 Mohm DI water. Total confidence in certified concentrations is ensured by VHG brand advanced QC and assay procedures known as the NIST High Performance ICP-AES method with ICP-MS purity verification. Each standard that LGC produces for USP and ICH Q3D compliance meets the stringent requirements of ISO 17034 and ships with a comprehensive, NIST (National Institute of Standards and Technology) traceable certificate of analysis. LGC’s reference standards for pharmaceutical testing include more than 5,000 APIs, their impurities, excipients and primary reference standards. Featured Article

Microbioz India, August 2023 | 22 Introducing the DVS Carbon: A Revolutionary Advancement in CO2 Capture Research Surface Measurement Systems proudly presents the future of carbon capture research - the DVS Carbon, a cutting-edge gravimetric sorption analyser designed for advanced carbon capture applications. This purpose-built instrument boasts unique features tailored to enable precise measurements of CO2 uptake in materials under real-world conditions. By providing comprehensive control over temperature and humidity across a broad range of high and low CO2 concentrations, the DVS Carbon empowers researchers with unprecedented insights. The DVS Carbon emerges as an innovative tool in the realm of Carbon Capture, Utilization, and Storage (CCUS) applications, promising a plethora of benefits for future research and development: Enhanced Carbon Capture Efficiency: Leveraging the DVS technique to precisely characterise material properties, researchers can calibrate factors like pore size and surface area, significantly enhancing CO2 uptake for critical industrial purposes such as power plants and emissions reduction. Expand Carbon Capture, Utilization, and Storage (CCUS) development: The DVS Carbon is a catalyst for progress in Carbon Capture, Utilization, and Storage endeavours. It facilitates the development of advanced materials that improve efficiency and safety while fostering a truly circular economy. Embracing a sustainable future: By actively researching and designing new materials for CO2 capture, scientists play a crucial role in building a sustainable future. The DVS Carbon offers unparalleled detail and precision in CO2 generation and measurement DVS Carbon: The next step in CO2 capture research Featured Article

Microbioz India, August 2023 | 23 These materials have the potential to be instrumental in achieving global climate goals and reducing greenhouse gas emissions. Evolving solutions for an evolving issue: CO2 emissions emanate from diverse sources, including power plants, industrial processes, and transportation. The DVS Carbon's capabilities allow researchers to analyse materials under a range of real-world conditions, enabling thorough assessment of new materials' performance. Extensive instrument capabilities: The DVS Carbon offers an array of extended capabilities, from in-situ sample activation to extended humidity generation, all possible at a wide temperature and CO2 concentration range, making it the most versatile carbon capture analyser on the market. Controlling and reducing carbon emissions is one of the biggest global challenges of our generation. Scientists have an ever-increasing need to understand the performance properties of materials they wish to employ in carbon capture, utilization, and storage. This is where the story of the DVS Carbon began. The beginnings of the DVS Carbon trace back to September 2021 when Prof. Daryl Williams, Founder & MD of Surface Measurement Systems, identified a considerable demand for an instrument capable of measuring CO2 uptake capacity in materials. This marked the start of an intensive R&D effort and combined resourcing from our multidisciplinary team. The Road to the DVS Carbon: November 2021 - Surface Measurement Systems’ patented Speed-of-Sound sensor is reinvented to measure precise carbon concentrations, enabling accurate carbon concentration generation and readings. February 2022 - Our diligent R&D team develop the first working prototype of this exciting new instrument. May 2022 - The instrument is dubbed the DVS Carbon. October 2022 - A highly desired application among the research community is added to the capabilities of the instrument: to measure adsorbent's CO2 sorption capacity for Direct Air Capture Performance. May 2023 - Findings developed on the DVS Carbon are published for the first time with our overview of DVS gas capture applications. July 2023 - The DVS Carbon launches to the global research community, opening a new frontier for carbon capture determination. By introducing the DVS Carbon, Surface Measurement Systems has pioneered a groundbreaking tool in the field of Carbon Capture, Utilization, and Storage. Its unmatched instrument design and measurement capabilities empower researchers to characterize materials' CO2 capture potential across a range of concentrations and humidities, enabling precise measurement under dynamic real-world conditions and beyond. You can find out more about DVS Carbon and download the Product Brochure at www.surfacemeasurementsystems.com. Catalyzing research for advanced Carbon Capture, Utilization, and Storage research Featured Article

Microbioz India, August 2023 | 24 NEW: PRESTO W58x- JULABO's Highly Dynamic Temperature Control System ULABO, a world-renowned manufacturer of premium temperature control solutions, is expanding the cooling performance of its PRESTO series with the introduction of this new juggernaut. The new power pack from JULABO enables temperature control processes to be conducted even faster and more efficiently. With a very high cooling capacity of 33 kW at +20 °C, the W58x offers large power reserves over the entire working temperature range, especially at temperatures around -30 °C to -40 °C in connection with waterglycol mixtures. The gear pump installed in the W58x also enables the use of media with higher viscosity. As the pump is magnetically coupled, it further allows for optimal adjustment of pump performance to the application, even across greater distances and elevations. "With the PRESTO W58x, we are offering a premium unit with even more power," emphasizes CMO and Director of Sales Mark Bitterwolf. "Especially in automotive testing, we thus enable our customers to carry out their temperature control processes even faster and more efficiently. The W58x leaves nothing to be desired in this regard," Bitterwolf continues. Perfect for Automotive Applications Tailor-made solutions from a single source The new PRESTO W58x leaves nothing to be desired, especially for automotive clients. Not least because JULABO can offer individual solutions from a single source depending on requirements. An expansion kit allows pressure-overlaid temperature control with water-glycol up to a working temperature of +150 °C. A specialized flow control system extends the performance range of the W58x to applications requiring precisely defined volumetric flow rates of the utilized medium. For more information: Scientific Research Instruments Company Private Limited +91 9900674407 | [email protected] | www.srico-labworld.com About Julabo: Since JULABO’s foundation in 1967 the company has pioneered the development of technology for liquid temperature control. JULABO equipment is used successfully around the world providing application solutions for science, laboratories, technology centers and process industries. J Featured Article

Microbioz India, August 2023 | 25 The current program features heating and refrigerated circulators, highly dynamic temperature control systems, recirculating coolers, water baths and additional special equipment. Their integrated highly precise control technology is unique. It guarantees highly accurate temperatures and rapid reaction to temperature changes. Another special feature of JULABO units: no side vents. Operation of JULABO instruments is intuitive. All important information is displayed intelligibly and easy to read. The parameters for any application are set quickly using only a few keys. JULABO also offers specialized equipment for individual applications and an extensive list of accessories for all products. About SRICO: SRICO is a professionally managed Laboratory Equipment Company established to deliver the best solutions available from internationally reputed manufacturers in the field of Research and Development and Quality Control for industries and educational institutions. SRICO is founded by a qualified engineer experienced in Scientific Instrumentation industry both in India and several countries in Asia for the past 25+ years. Featured Article

Microbioz India, August 2023 | 26 FibertecTM 8000: First fully automated fiber analysis solution following official reference methodologies he FibertecTM 8000 is a fully automated system for measuring crude fiber, detergent fiber, and associated characteristics using industryrecognized reference "crucible" methods like Weende, van Soest, etc. A fiber solution with the shortest operator time Up to six samples can be measured unattended, freeing up staff time for other tasks. Time is saved, and the possibility of human error is eliminated, thanks to on-board heating, automatic distribution of all chemicals, antifoam, and water rinsing. Results from the official reference method with unmatched precision As sample residue stays in the crucible throughout the process, there is no sample transfer and no chance for error. Reliable reference results are ensured by discretely analyzing each sample in accordance with official procedures, and repeatability is guaranteed by a constant heating rate and time to boiling. Safest fiber analysis method currently obtainable Automated processes can help to ensure safety by distributing reagents to prevent contact with chemicals and fumes, reducing the temperature at the boiling point to prevent spills, and adding enzymes and anti-foam as needed. For more information: Contact No: +91-022-6908 6000 / 6110 Email ID: [email protected] Website: www.labindia-analytical.com About FOSS & Lab India: Labindia Analytical and FOSS India have joined forces to bring you unparalleled expertise in the field of Chemical Analysis. As partners, Labindia Analytical will distribute FOSS India's cutting-edge solutions, specializing in this domain. Together, we aim to revolutionize your analytical processes, delivering accurate, reliable, and efficient results for Protein, fat and fibre analysis. Labindia Analytical's commitment to customer satisfaction, combined with FOSS Analytical's exceptional product line, ensures that you will have access to the most advanced instruments and unmatched support. About Lab India: Labindia Instruments was founded and promoted in 1982 by a group of visionary technocrats and entrepreneurs who envisaged the need for highquality and technologically advanced analytical instrumentation across India. Industries in India were growing at fast pace and needed precision instruments that were at par in quality with the global leaders, reasonably priced, and backed by robust after-sales-service. T Featured Article

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Microbioz India, August 2023 | 28 Everything you need to know about how to buy the best lab mixers ab mixers facilitate the blending of relatively smaller volumes of substances, often ranging up to 100 gallons (380 liters). The laboratory mixer is capable of accommodating solutions with viscosities of up to 150,000 cps, a characteristic that is contingent upon the torque, horsepower, and speed of the mixer. The available types of lab mixer motors include permanent magnet, universal, and air-drive. Select various mixer mounts suitable for installation on tanks or support stands. The diverse range of impellers and paddles available for selection enhances the versatility of the laboratory mixer. What are the different types of mixers? Types of lab mixers in laboratory There are a variety of fundamental categories of laboratory mixers: Dual-shaft mixers utilize a three-wing or helical anchor to generate flow and eliminate mixed substances from the vessel wall. Double-planetary mixers deliver material to an orbiting high-speed dispenser (HSD) via a rectangular or finger-shaped blade. Single-stage rotor/stator machines use a stationary stator to rapidly rotate an immersed rotor. The blades pass through each stator inlet and expel material at high velocity into the surrounding environment. Rotor/stator mixers with multiple stages enhance shearing to generate smaller particle sizes and more homogenous batches. When two to four rotor/stator pairs are nested concentrically, the combined material that moves outward from the center of the unit is sheared rapidly and sequentially. Tips of buying perfect lab mixers Numerous factors exhibit variation between different laboratory mixers and shakers: 1. The initial stage in the process of selecting an appropriate machine involves making a determination between opting for a lab mixer or a shaker. 2. When considering the selection of a shaker, it is advisable to examine the vibration speed, the degree of adjustability in speed, and the presence of plate tilting capabilities in addition to vibration. 3. When considering the mixer as the subject of analysis, there exist numerous qualities that may be compared. L Featured Article

Microbioz India, August 2023 | 29 4. The capacity of the container, mixing speed, speed variability, ability to manage liquid viscosity, and horsepower will exhibit variation. An additional factor to take into consideration is to the inclusion of a mixer that is accompanied by a container, or alternatively, the requirement of a mount to affix it onto pre-existing containers. 5. The compact dimensions of laboratory mixers are often regarded as a significant benefit, as they may be conveniently accommodated inside a laboratory environment. 6. Consequently, it is imperative to take into account not only the limited spatial capacity but also the desired quantity of mixers. The utilization of a bench allows for the simultaneous operation of many mixers, facilitating the execution of numerous tests concurrently. 7. When choosing a mixer, it is important to take into account the size of the mixtures that will be prepared. Various applications necessitate varying volumes, and certain mixers address this requirement by providing a broad capacity range spanning from a few millilitres to several litres. It is important to consider that the capacity of a tool will have implications for the type of tool needed for specific applications as well as the rotating speed. The mixer design can be influenced by the type of beaker and accessories utilized, such as lift table, water bath, and hot plate. It is vital to ensure that these accessories possess the capability to smoothly glide into the mixing area. Laboratory Mixers Frequently Asked Questions (FAQs) What is a mixer used for in a lab? Mixers and shakers are types of laboratory equipment that help to create a consistent mixture out of multiple components by agitating and mixing them together. Laboratory mixers and shakers are an essential component of many different types of research facilities. These machines find use in a wide variety of industries, including those dealing with life sciences, wastewater treatment, and biotechnology, in addition to the food and beverage, cosmetic, pharmaceutical, and electronic product manufacturing sectors. Players in Laboratory Mixer market IKA-Werke, Eppendorf AG, Thermo Fisher Scientific, Shuanglong Group Co. Ltd, Bio-Rad Laboratories Inc., REMI GROUP, Benchmark Scientific Inc, Silverson, Cole-Parmer, INXIS Group, and SARSTEDT AG & Co. KG are only few of the market leaders. Featured Article

Microbioz India, August 2023 | 30 Accurate Weighing Through GWP® - The Global Weighing Standard ood Weighing Practice™ (GWP®) is the science based global weighing standard for the efficient life cycle management of weighing systems. It ensures consistent accuracy, quality and compliance in any weighing process. GWP’s risk-based approach ensures that all your weighing devices meet your own accuracy requirements and adhere to quality standards such as ISO, GMP and GLP. It is applicable to new or existing weighing devices from any manufacturer in any industry or workplace. Regular verification and control of weighing equipment is an essential part of ISO, GLP or GMP quality management systems, ideally conforming to a risk management process. It ensures that instruments continually perform to a high standard, meeting specifications and fulfilling current regulatory demands. This requirement is made clear in the OECD (Organisation of Economic Cooperation and Development) publication “Principles of Good Laboratory Practice, Chapter 4.2: Use, Calibration, and Maintenance of Equipment“, which states that ‘Apparatus used in a study should be periodically inspected, cleaned, maintained and calibrated according to Standard Operating Procedures (SOPs). It is the responsibility of test facility management to ensure that instruments are adequate and functioning according to their intended use’. The US Pharmacopeial Convention takes this one step further, with “USP Chapter 41” recommending the adoption of a risk management approach to scheduled calibration and routine testing of weighing equipment. The first, and essential, step in any laboratory application or workflow is to ensure that all balances are correctly calibrated and routine testing of equipment is up to date; optimizing maintenance procedures and balance verification intervals will help eliminate inaccurate readings and reduce downtime. Generally, laboratory balances are checked on a regular basis for any deviation in sensitivity – the difference between the calibrated weight and the displayed value, ideally measured at the maximum capacity of the balance – and repeatability, defined as the standard deviation of 10 measurements of a weight below 5% of the capacity of the balance. Further testing, including linearity and eccentricity, is best performed by a fully trained service technician during annual / biannual balance calibration procedures. METTLER TOLEDO developed GWP®, Good Weighing Practice™, as a standardized scientific methodology for secure selection, calibration and operation of weighing equipment. Benchmark Your Quality Management System GWP® Verification helps you assure accurate weighing results as part of your quality management system. Applicable for all balances and scales, it provides an optimized testing and calibrating scheme which may translate to sustainable time and cost savings. Your Benefits • The accuracy of your weighing instruments is matched to your process tolerances. • A comprehensive summary report provides an overview of the status of all weighing equipment. G Featured Article

Microbioz India, August 2023 | 31 • An optimized routine testing and calibration schedule results in sustainable cost savings. • Audit-proof and up-to-date documentation complements your quality management system. For your success: you focus on your process, we take care of the measurement. About METTLER TOLEDO METTLER TOLEDO is a leading global manufacturer of precision instruments. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. The Company also holds top-three market positions for several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection systems used in production and packaging. Additional information about METTLER TOLEDO is available at www.mt.com. Visit us: www.mt.com/gwp Email us at – [email protected] Call us toll-free at – 1800 22 8884 & 1800 1028 460 Featured Article

Microbioz India, August 2023 | 32 Aseptic connections for fluid transfer in Biopharma and Pharma industry here is a wide range of processing technologies Aseptic connections, they can be supplied as either discrete components or more often as pre-validated, pre-sterilized single-use systems – ready to open and use. They are used to connect single-use fluid paths – these falls into two basic categories based on how the connection is achieved: those that connect by welding or fusing together two fluid paths and those that mechanically couple two components installed in the fluid pathway. The advantages of aseptic connectors are not only that they provide more robust sterility assurance, the connectors also permit the operation to be conducted within a lower classification for the surrounding cleanroom (for example, where a traditional connector would require ISO class 5 / EU GMP Grade A, and ISO class 7 / EU GMP Grade B area could be used). Aseptic Connectors Sterile connectors for aseptic processing (commonly referred to as ‘aseptic connectors’) enable two lines of tubing to be joined while maintaining a sterile fluid pathway. Each line of tubing is pre- connected to one connector end. At the end of the connector is a removable membrane which facilitates the two pieces of tubing to connect (mechanical coupling). Once the two connectors ‘connect’ the membrane is removed. Through the act of connection, the process line is maintained as closed and sterility ideally assured. Furthermore, whereas the risk with traditional connectors includes the operator and hence finger plates are typically taken, the aseptic connector does not require finger plates to be taken as the impact of the operator and the level of bioburden carried on gloved hands will not affect the assurance of sterility as the connection is made. Traditional biologics like vaccines and mAbs as they have been early adopters of aseptic connectors and single-use technologies (SUT) overall. Some of the main benefits that led to SUT adoption are: 1. Cost- Reduced manufacturing cost by elimination of cleaning and sterilisation steps 2. Speed – Time and labour savings during setup and between operational cycles 3. Sterility – Elimination of cross contamination between batches Thermoplastic elastomer tubing and Sterile welder To create an aseptic connection between the two lengths of complementary thermoplastic tubing, sterile tubing welders were built. Two ends of tubing from the same module are firmly inserted into the tube clamp mechanism as part of the welding process configuration. Sterile tubing welders make connections quickly and safely while maintaining a functionally closed system, whether dry tubing or wet tubing is being attached. Crosscontamination is limited because each wafer is thrown after a single-use. A functionally closed system is maintained by the ideal sterile welder. A general question that can arise is how to determine if you should use a tube welder or an Aseptic connector. Tube welders are commonly used when a small number of connections are to be made per day and when only one dimension of tubing is used. As the number of connections increase use of aseptic connectors is preferred as they provide more flexibility of using multiple tube sizes and take less time as tube welding takes more time. Aseptic connectors are available in both gendered and genderless versions. Gendered connectors are composed of two different connectors (typically male and female component) connected together to create a fluid pathway. T Featured Article

Microbioz India, August 2023 | 33 In Genderless connectors two components brought together to make a connection are identical. Genderless connector offers various significant advantages over gendered connector leading to time saving, reduced inventory, increased operational and design flexibility. Assembly Considerations A single-use assembly provider should be flexible when working on a client's design that includes sterile connectors. Tubing types, methods of securing tubing onto connectors (i.e., cable ties, barb locks), and willingness to use customerspecified components (i.e., those of their competitors) are aspects that should be considered when customers are selecting suppliers. Other factors to consider are sterilization options, genderspecific assemblies, and pricing. Typically, two options are available for sterile connectors. The manufacturer may provide the connector on an assembly that has been presterilized by gamma irradiation. Alternately, connectors may be autoclaved along with assemblies made in-house. Testing Needs and Documentation Expectations Various tests should be performed on Aseptic connectors to ensure connector has been challenged using worst case condition for proper selection and to mitigate risk. Some of the common tests performed are: Bacterial Challenge: The bacterial challenge test typically is done by exposing the connector mating surfaces to a bacterial solution (by direct soiling or by aerosol) with a minimum colony forming unit (CFU) concentration, assembling the connection, passing sterile media through the connection, and collecting it. After incubation of the collected sample, absence of microbial growth confirms prevention of ingress of a contaminant. Proper controls must be demonstrated. Pressure and temperature tests are other important tools in validating components for use within specific applications. Bubble leak testing is performed to verify the integrity of these components in a variety of temperature and pressure conditions potentially found in certain bioprocessing applications. Another key assessment for components utilized for bioprocessing are bioburden and endotoxin particulate tests, which are designed to validate that components are free of a range of living organisms (bioburden) and gram-negative bacteria (endotoxins) that could compromise a system. End users are responsible for evaluating the functionality and performance characteristics of a connector or component before integrating it into a bioprocessing application. Training Training in the use of these consumables is highly recommended to ensure they provide an integral connection. Implementing these products involves a number of steps and some require careful attention to avoid such mishaps as over- or underactuation, misalignment, displacement of o-rings, and interference with membranes (i.e., peeling them off inappropriately). Conclusion Sterile connectors make operation easier and faster than other methods of connections in an aseptic environment, such as open manipulations, while completing the path of a sterile closed system. Nonetheless, due diligence is required to ensure that an appropriate connector type is selected and tested to satisfy the user, product requirements, system integrity, and safety. Written By: Mr. Prabhat Balyan Asst. Manager - Business Development Ami Polymer Private Limited [email protected] Featured Article

Microbioz India, August 2023 | 34 NIH and Exothera collaborate to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US he National Institutes of Health (NIH), the US’s medical research agency, selected Exothera S.A., a full-service Contract Development and Manufacturing Organization (CDMO) specialized in gene therapy, vaccines, oncolytic viruses, and nucleic acid-based therapeutics, to develop the manufacturing process for NIH’s intranasal vaccine against SARS-CoV-2. As part of the Cooperative Research and Development Agreement, CRADA, they will be joined by researchers from Dartmouth Health’s Dartmouth Hitchcock Medical Center (DHMC) and Dartmouth’s Geisel School of Medicine with special expertise in mucosal immunity and the design and conduct of early phase clinical trials. Live, replicating, intranasal vaccines have the promise of effectively interrupting transmission of coronavirus, COVID-19 by inducing the development of immunity in the respiratory tract. Further, intranasal vaccines are a potentially valuable alternative to injected vaccines as no specific medical training is required to perform the vaccination, similar to the oral drops given globally to prevent polio. The World Health Organization (WHO) lifted the Public Health Emergency of International Concern for COVID-19 on May 5, 2023, but adequate levels of vaccination of the global population remain crucial to reduce morbidity, mortality, and the risk of emerging new virus variants. Intranasal vaccines are also an impactful tool for the distribution of a vaccine against SARS-CoV-2 in remote areas with the potential to slow transmission of COVID-19 in these regions. In the past, intranasal vaccines have been used to fight several mucosa-entering pathogens (e.g., respiratory viruses, measles, rubella). NIH’s candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials, produced in an A549 cell line. Exothera will generate cGMP material using NIH's current manufacturing and analytical processes for use in US and African Phase I/II clinical trials. The project includes tech transfer, stability study, CMC study and AS development and QC testing, before initiating manufacturing of the drug product in its GMP facility in Jumet, Belgium - one of the biggest dedicated viral vectors plants in Europe that can accommodate projects from development to commercial manufacturing scale. Hanna Lesch, Chief Technology Officer at Exothera commented "We are proud NIH selected us for this project. T Business News

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Microbioz India, August 2023 | 36 Exothera has had significant expertise with adenovirus viral vectors and COVID nasal vaccines in the last three years, thanks to successful collaborations with partners and clients specialized in viral vector-based vaccines". Peter Wright, MD, infectious disease, and international health physician at DHMC and Professor of Paediatrics at Geisel. "We are pleased to join this collaborative effort to develop and assess the safety, immunogenicity, and effectiveness of an adenovirus type 4-based vaccine expressing the SARS-CoV-2 spike protein as a novel approach to the prevention of COVID-19. Although unique in the COVID field, the vaccine has precedent in the highly successful prevention of adenovirus respiratory disease in the United States military." This content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. About Dartmouth Health Dartmouth Health, New Hampshire’s only academic health system and the state’s largest private employer, serves patients across northern New England. Dartmouth Health provides access to more than 2,000 providers in almost every area of medicine, delivering care at its flagship hospital, Dartmouth Hitchcock Medical Center (DHMC) in Lebanon, NH, as well as across its wide network of hospitals, clinics, and care facilities. DHMC is consistently named the #1 hospital in New Hampshire by U.S. News & World Report and is recognized for high performance in numerous clinical specialties and procedures. Dartmouth Health includes Dartmouth Cancer Center, one of only 53 National Cancer Institutedesignated Comprehensive Cancer Centers in the nation, and the only such center in northern New England; Dartmouth Health Children’s, which includes the state’s only children’s hospital and multiple locations around the region; member hospitals in Lebanon, Keene and New London, NH, and Windsor and Bennington, VT; Visiting Nurse and Hospice for Vermont and New Hampshire; and more than 24 clinics that provide ambulatory and speciality services across New Hampshire and Vermont. Through its historical partnership with Dartmouth and the Geisel School of Medicine, Dartmouth Health trains nearly 400 medical residents and fellows annually and performs cutting-edge research and clinical trials recognized across the globe with Geisel and the White River Junction VA Medical Center in White River Junction, VT. Dartmouth Health and its more than 13,000 employees are deeply committed to serving the healthcare needs of everyone in our communities, and to providing each of our patients with exceptional, personal care. About Dartmouth’s Geisel School of Medicine Founded in 1797, the Geisel School of Medicine at Dartmouth strives to improve the lives of the communities it serves through excellence in learning, discovery, and healing. The Geisel School of Medicine is renowned for its leadership in medical education, healthcare policy and delivery science, biomedical research, global health, and in creating innovations that improve lives worldwide. As one of America’s leading medical schools, Dartmouth’s Geisel School of Medicine is committed to training new generations of diverse leaders who will help solve our most vexing challenges in healthcare. Website: https://geiselmed.dartmouth.edu/ About Exothera SA Exothera is a contract development, and manufacturing organization (CDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers process development/optimization to rapidly reach GMP clinical and commercial production of vaccines, viral vectors, and nucleic acids. At Exothera and Univercells, our mission is to make life-changing therapies available to all. Website: www.exothera.world Contacts Exothera For Media: Jonathan Lecocq, [email protected], +32 476 81 12 44 Business News

Microbioz India, August 2023 | 37 Lonza Launches Nebula® Absorbance Reader for Streamlined Endotoxin and Pyrogen Testing 1. Lonza adds new Nebula® Absorbance Reader to its portfolio of Lonza-developed and optimized microplate readers for streamlined endotoxin and pyrogen testing 2. The instrument is fully integrated with Lonza’s latest WinKQCL® Software to enable data integrity compliance, streamline training, and reduce validation burden 3. The optimized reader offers premium performance when used in combination with Lonza reagents onza has launched the Nebula® Absorbance Reader, a new absorbance microplate reader which joins the company’s portfolio of optimized instruments for streamlined endotoxin and pyrogen testing. Pharmaceutical quality control (QC) laboratories worldwide rely on the traditional absorbancebased Limulus amebocyte lysate (LAL) and Tachypleus amebocyte lysate (TAL) assays to assure the safety of raw materials in-process samples and manufactured products. However, the industry-standard absorbance reader for these assays — the ELx808™ Absorbance Microplate Reader (ELx808™) — will no longer be sold by Lonza from late 2023. The Nebula® Absorbance Reader represents a technologically advanced, highperformance replacement reader, which delivers results comparable to those typically found with ELx808™ and will facilitate the smooth continuation of current pyrogen and endotoxin testing programs. Similar to the Nebula® Multimode Reader, the Nebula® Absorbance Reader is designed for use alongside Lonza reagents. It is optimized to work with, and meet all the specifications of, Lonza’s absorbance-based endotoxin assays such as the Lonza PYROGENT® 5000 Turbidimetric and Kinetic-QCL® Chromogenic Endotoxin Assays. The new reader also supports the readout for monocyte activation tests (MAT) such as Lonza’s PyroCell® MAT System. The Nebula® Absorbance Reader provides QC labs with new and improved functionality. It features high-performance optics and monochromator-based wavelength selection to enable precise and accurate measurements of endotoxin levels. Its compact design requires minimal laboratory space and allows for workflow flexibility. The reader is fully integrated with the latest version of Lonza’s WinKQCL® Endotoxin Detection and Analysis Software (v6.4), enabling users to meet the latest data integrity requirements. This reduces training burdens by removing the need for existing WinKQCL® Software users to learn new software in order to use the new reader. In addition, the Nebula® Absorbance Reader is similar in design and build to the Nebula® Multimode Reader – using the same user manual, service tools, and similar qualification procedures – which simplifies system maintenance. L Business News

Microbioz India, August 2023 | 38 Orla Cloak, Vice President, Head of Bioprocessing, Lonza, commented: “As we developed the new Nebula® Absorbance Reader, we focused on optimizing functionality to enable it to provide the very best results for our customers. QC teams can now access a thoroughly tested absorbance reader, specifically optimized for use with Lonza reagents and fully integrated with our WinKQCL® Software. This launch will allow customers to confidently continue endotoxin workflows in the same smooth and streamlined way they are used to, with the support of new and improved testing functionality.” Lonza will present data from the Nebula® Absorbance Reader used with Lonza endotoxin assays during a poster presentation at the 2023 PDA Pharmaceutical Microbiology Conference in Washington, DC (US) from 2–4 October 2023. Additional Information For more information on the Nebula® Absorbance Reader, please visit: www.lonza.com/absorbance-nebula Lonza Contact Details [email protected] Disclaimer Certain matters discussed in this media advisory may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forwardlooking statements included in this media advisory due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this media advisory. All trademarks belong to Lonza, and are registered in USA, EU or CH or belong to third party owners and are used only for informational purposes. Business News

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Microbioz India, August 2023 | 40 SSI Strategy and NDA Group Combine to Form Best-in-Class Global Life Sciences Consultancy Combination Creates a Leading, Integrated Provider of Drug Development and Regulatory Consulting Services Serving a Complementary Client Base SI Strategy ("SSI" or the "Company") a leading Life Sciences consultancy, today announced that it has entered into a definitive agreement to acquire NDA Group AB ("NDA Group"), a leading regulatory affairs and drug development consultancy. This strategic combination will create a premier consultancy, specializing in guiding drug development companies from concept to commercialization, helping optimize the development process and maximize the therapeutic value of complex and novel treatments. The merger marks an exciting milestone following years of successful collaboration across numerous clients, resulting in the launch of the most innovative therapies available in the world today. Financial terms of the transaction were not disclosed. SSI is a premier Life Sciences consultancy that has been working with clients to accelerate all stages of drug development since 2007. SSI’s core competencies include clinical development, translational medicine, clinical operations, medical affairs, pharmacovigilance, health economics and outcomes research (HEOR), and real-world evidence (RWE) services. With a team of experts spanning the U.S. and Europe, the Company works closely with drug development clients to provide an innovative and bespoke support model including embedding fully functional teams. SSI’s R&D experts and clinicians’ partner with clients to close gaps and achieve objectives across the drug development landscape. In December 2020, SSI partnered with Amulet Capital Partners, a middle-market private equity investment firm focused exclusively on the healthcare sector, to fuel its expansion and grow its capabilities in adjacent Life Sciences functions. Founded in 1997, NDA Group has an extensive presence across the EU, UK, Switzerland, and the U.S. For over 25 years, NDA Group has provided the life science industry with unmatched regulatory expertise, ensuring that they meet the rigorous demands of the regulatory agencies. The team at NDA Group comprises over 100 exregulators, industry experts and highly experienced consultants dedicated to helping drug developers make the right decisions to secure the safest and most efficient pathway to approval for their products. "NDA Group is regarded as the premier regulatory consultancy for Life Sciences companies across the U.S. and Europe, and we’re delighted to build upon our longstanding partnership with this combination," said Doug Locke, Chief Executive Officer of SSI Strategy. "This transaction brings together two highly regarded consultancies to create an integrated, end-to-end provider of drug development and regulatory consulting services. Combined, we will provide our common client base with best-in-class clinical development and regulatory expertise. S Business News

Microbioz India, August 2023 | 41 Over years of collaboration between our businesses, we have proven our ability to execute together and are confident the success we have shared on prior partnerships will translate into more value for our clients from day one." Johan Strömquist, CEO of NDA Group, commented, "SSI’s unparalleled combination of business acumen and medical expertise has formed a unique space in the Life Sciences market. We are excited to join forces with them to expand upon this platform together. While NDA Group has been a world leading regulatory development consultancy for the past 25 years, there are still challenges that biotechs face that we have not been able to fully address. Together with SSI, we can not only optimize the regulatory path, but now also partner with our clients to execute the entire development program. For our clients, this will mean reduced risk, reduced costs, increased success rates and faster time to market. For the patient, this means higher quality treatments without unnecessary delay." Avi Uttamchandani, Principal at Amulet added, "Together, SSI and NDA will create a leading Life Sciences and drug development consultancy positioned to support both emerging and established biotechnology companies at every stage of the drug development and approval process. This combination will significantly enhance SSI’s regulatory support services and grow its industry leading team of experts while positioning the Company to grow its geographic footprint and expand its presence serving clients across the U.S. and Europe." Following the close of the transaction, NDA will operate as a strategic business unit (SBU) under SSI. SSI Strategy President Adam Schwartz will continue to lead SSI’s operations while the NDA management team will continue leading the NDA SBU under the guidance of President Johan Stormiest. Interested in partnering with SSI? Contact [email protected]. About SSI Strategy SSI Strategy combines business acumen with medical, clinical, pharmacovigilance and regulatory domain expertise to provide best-in-class support for our clients. Our staff of ex-chief medical officers, former heads of medical affairs, clinical, safety, regulatory, and health authority leaders will work to ensure the right balance of scientific and commercial focus to drive unparalleled client outcomes. SSI Strategy is headquartered in Parsippany, NJ, with offices in Boston, London, Munich, New York, San Francisco, Stockholm, and Zurich. Learn more at www.ssistrategy.com About NDA Group NDA Group is a world-leading regulatory and drug development consultancy company, with 25 years of unparalleled expertise and an extensive portfolio of services through all phases of drug development. Our dedicated team of over 150 consultants combined with the unique NDA Advisory Board provide drug developers with unmatched regulatory expertise, ensuring the safe development of complex & innovative treatments that meet the rigorous requirements of the regulatory agencies. Over the last three years, NDA Group has supported a quarter of the new medicinal products approved in the US and Europe. www.ndareg.com About Amulet Capital Amulet Capital Partners is a middle-market private equity investment firm that focuses exclusively on creating long-term value for market leaders in the healthcare sector. The experienced principals at Amulet currently manage over $1.8 billion in healthcare investments. With over 50 years of deep industry experience and strategic relationships, Amulet helps solve complex and dynamic challenges in a wide range of healthcare segments. www.amuletcapital.com Contact: SSI Strategy / Amulet Jon Keehner / Erik Carlson Joele Frank, Wilkinson Brimmer Katcher (212) 355-4449 NDA Group Denise Strömquist Global Head of Marketing & Communications, NDA Group [email protected] Business News

Microbioz India, August 2023 | 42 Cipla launches CIPLAMED 2.0 – knowledge-sharing platform for Healthcare Practitioners (HCPS) ipla announced the launch of CiplaMed 2.0, an enhanced version of the industryleading knowledge platform for the medical fraternity. In line with its digital transformation agenda, Cipla is pioneering an integrated omnichannel experience for healthcare professionals that seamlessly combines in-clinic interactions with digital engagement and access to medical information. This initiative underscores the growing importance of digital platforms in the medical education and the use of technology to empower HCPs with vital information to cater to their patients. CiplaMed is designed to provide healthcare professionals with reliable, accurate and current updates and clinically relevant content across 19 specialities from the global medical fraternity, with a strong focus on patient care. This includes scientific articles, webinars, podcasts, expert talks, patient education resources and content integrated from CiplaMedX, Cipla’s exclusive video content platform. The revamped platform also offers access to content which is tailored to the doctors specialization, allowing users to conveniently share and bookmark information. With a steady monthon-month growth rate of approximately 2x over the past three months, the platform has garnered a dedicated user base of 12,000 professionals. Since its inception, constant user acceptance testing adoptions and the use of customer engagement tools helps the platform adapt with the evolving needs of healthcare practitioners. CiplaMed 2.0 leverages advanced analytics and automation, which have the potential to transform knowledge-sharing in the pharmaceutical industry. Dr Reddy's application for biosimilar candidate accepted for review by USFDA Dr Reddy's rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. r Reddy's currently collaborating with Fresenius Kabi, a global healthcare company, to commercialise the proposed biosimilar of rituximab in the US. Dr Reddy's Laboratories on Wednesday said its biologics licence application for its proposed biosimilar rituximab candidate has been accepted for a substantive review by the US Food and Drug Administration (USFDA). This closely follows acceptance of the rituximab biosimilar dossier for review by two other regulatory agencies -- the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). Rituximab is used to treat certain autoimmune diseases and types of cancer. "This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets," Dr Reddy's Global Head of Biologics Jayanth Sridhar said in a statement. It also reinforces the potential of the product as a safe and effective treatment option for patients across the globe, he added. Development and commercialisation of biological drugs is an important growth lever for the company's business, Sridhar noted. "We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030," Sridhar said. Dr Reddy's rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with Fresenius Kabi, a global healthcare company, to commercialise the proposed biosimilar of rituximab in the US. The Hyderabadbased company intends to commercialise the product in Europe and other geographies directly, it added C D Pharma News

Microbioz India, August 2023 | 43 Lupin Receives Approval from U.S. FDA for Doxycycline Hyclate DelayedRelease Tablets USP lobal pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-Release Tablets USP, 50 mg, 60 mg, 75 mg, 80 mg, 100 mg, 120 mg, 150 mg, and 200 mg, to market a generic equivalent of Doryx® Delayed-Release Tablets, 50 mg, 75 mg, 80 mg, 100 mg, 150 mg, and 200 mg and Doryx® MPC Delayed-Release Tablets, 60 mg and 120 mg, of Mayne Pharma International Pty. Ltd. This product will be manufactured at Lupin’s Pithampur facility in India. Doxycycline Hyclate Delayed-Release Tablets USP (RLD Doryx ®) had estimated annual sales of USD 9 million in the U.S. (IQVIA MAT June 2023). About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the antiinfective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector Glenmark gets USFDA nod to market generic diabetes drug lenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca’s Onglyza1 tablets, the Mumbai-based drug maker said in a statement. According to IQVIATM sales data, for the 12- month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million. Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA. (PTI) Micro Labs Ltd introduces Trisopt: World’s first triple drug fixed-dose combination for Glaucoma Management icro Labs Ltd, a renowned pharmaceutical company, proudly announced the launch of Trisopt, the world’s first fixed-dose combination of Brimonidine, Timolol, and Brinzolamide ophthalmic suspension for glaucoma management. Trisopt is an indigenous development from Micro G G M Pharma News

Microbioz India, August 2023 | 44 Labs, manufactured in their state-of-the-art facility located in Sikkim. Glaucoma remains one of the leading causes of irreversible blindness in India, affecting numerous lives. A significant number of glaucoma patients require multiple eye drops to control the disease progression, leading to challenges in medical management due to the high cost of therapy. At the recent annual conference of the All-India Ophthalmological Society held in Kochi, experts discussed the challenges faced by glaucoma patients, especially those on multi-drug regimens. Trisopt addresses this issue as the first triple drug fixed-dose combination for glaucoma management in India, offering improved efficacy and safety for patients who are not adequately controlled with a two-drug therapy. Trisopt will significantly enrich Micro Labs’ robust ophthalmic portfolio and extend support to numerous glaucoma patients in India, particularly those who require multi-drug therapy to control the progression of the disease. Micro Labs Ltd Introduces Trisopt Dilip Surana, Chairman and Managing Director of Micro Labs Ltd commemorated the launch of Trisopt on the occasion of the organization’s 50th anniversary. He stated, “Our endeavor has always been to listen, understand the needs of patients, and then provide best-in-class quality medications at affordable prices. Trisopt exemplifies this commitment and will empower ophthalmologists in their efforts to manage glaucoma effectively. Trisopt also underscores Micro Labs’ unwavering commitment to advancing healthcare in India.” He also emphasized Trisopt as a testament to our nation’s vision of “Make in India.” He also extended gratitude to the entire ophthalmic fraternity for their encouragement and guidance throughout this journey. He also acknowledged the relentless efforts of Micro Labs’ R&D, medical affairs, and manufacturing teams in making Trisopt a reality. Founded in 1973 by Sri. GC Surana in Chennai, Micro Labs has emerged as a leading pharmaceutical company, celebrating five decades of excellence in manufacturing high-quality, affordable generic medicines. With a diverse portfolio covering Cardiology, Diabetology, Pain Management, Dermatology, Ophthalmology, Veterinary, Neurology, and more, Micro Labs has been a trusted name in the healthcare industry. Micro Labs has grown exponentially, expanding its manufacturing presence across India and establishing a global footprint with offices in the US, UK, Germany, Australia, and Nigeria. Accreditations from esteemed international regulatory authorities, including US FDA, MHRA (UK), Health Canada, Medsafe (New Zealand), and Therapeutic Goods Authority (TGA) Australia, have earned Micro Labs the trust and confidence of healthcare professionals worldwide. With a team of over 13,000 employees globally and a legacy of awards for manufacturing excellence, responsible business practices, quality excellence, and patents, Micro Labs continues to be a driving force in the pharmaceutical industry. Pharma News

Microbioz India, August 2023 | 45 How to improve the reproducibility of your flow chemistry o enhance the reproducibility of flow chemistry scale-up - precise control of mixing and temperature in highly exothermic or rapid reactions is essential. The expanding range of Glass Static Mixer (GSM) chip reactor blocks from Uniqsis produce an efficient, turbulent mixed reagent stream for flow chemistry reactions that is not diffusion dependent. Available in sizes from 270µl to 20 ml, the Uniqsis range of high-quality GSM chips can be used to perform reactions from -80°C to over 150°C. GSM chips up to 2 ml can be operated up to 40-bar and are available in 2-channel or 3-channel inlet configurations. Larger GSM chips of 10ml and 20 ml have a premixing channel followed by a residence domain and can operate up to 10-bar. Glass Static Mixer chips can be used as mixing modules prior to a coil reactor residence time unit, or as reactor blocks for rapid exothermic reactions. GSM chips from Uniqsis are precision machined from inert borosilicate glass to withstand a wide temperature range and can be conveniently attached to a FlowSyn column heater module, Cold Coil or Polar Bear Plus cryogenic reactor module. For further information please visit https://www.uniqsis.com/paProductsDetail. aspx?ID=ACC_CHIP or contact Uniqsis on +44- 1223-942004 / [email protected] Since 2007, Uniqsis has specialised in the design and supply of mesoscale continuous flow chemistry systems for a wide range of applications in chemical and pharmaceutical research. The company’s aim is to make flow chemistry easily accessible to both novices and experienced users. T Product Launches

Microbioz India, August 2023 | 46 Automated software for HPLC pump validation ESTA Analytical Solutions e.K. announce a new software tool for its AB4000X range of flowmeters to enable labs to automatically validate the performance of HPLC, uHPLC and GPC/SEC pumps. The Pump Validation Software Suite has been designed to accept raw data generated by the TESTA Analytical flowmeter PC-App and perform all necessary flow calculations automatically. Caption: Pump flow validation test report generated using the new software tool Using this powerful software tool - all data and parameters are automatically validated for fitness of use for validation and a summary report generated which can be stored or printed for hard copy documentation. This powerful software tool comes with a Standard Operating Procedure (SOP) detailing the whole validation protocol. In addition, this new software can also be used to calculate ancillary pump performance parameters, such as real-time pulsation, which can be used to identify transient changes in pump performance. The AB4000X flowmeter range from TESTA Analytical sets the benchmark for real-time monitoring devices for continuously measuring the performance of pumps serving HPLC, uHPLC, LC/MS, GPC/SEC, and flow chemistry systems. Compatible with all common solvents, the compact AB4000X flowmeter powers itself from a USB connection. At the heart of each TESTA flowmeter is a highresolution thermal flow sensor that is both extremely accurate and sensitive. Caption: an AB4000X range flowmeter monitoring pump flow This non-invasive sensor enables the device to operate over a wide dynamic range. Each TESTA flowmeter is supplied with an easy-to-use PC based App that allows users to continuously record, and store measured flow rate data from a HPLC system. T Product Launches

Microbioz India, August 2023 | 47 Current flow rate is displayed on the devices integral high-resolution OLED display. For further information on the new software tool for automated validation of pump flow, using a AB4000X range flowmeter, please visit https://www.testa-analytical.com/hplcchromatography.html or contact Testa Analytical Solutions on +49-30-864-24076 / [email protected]. TESTA Analytical Solutions is a leading specialist supplier of liquid chromatography instruments and detectors. Drawing upon over 30 years’ experience, TESTA Analytical Solutions has established itself as a respected creator and supplier of top quality, innovative, high performance chromatography instrument kits, and detectors with OEM clients around the world. For Further Information: Media: Bill Bradbury (tel. +44-208-546-0869 / email [email protected] ) Technical: Carlo Dessy (tel. +49-30-864-24076 / email [email protected]) Product Launches

Microbioz India, August 2023 | 48 Fast and simple retrieval whole tissue samples The Mohawk 48 tube selector and picker from Ziath is designed to select and pick wide, heavy, or tall tubes making this new system perfect for retrieving individual whole tissue samples from storage. The Mohawk 48 uses forty-eight solenoid pins to enable a specific frozen or thawed sample tube to be raised and selected when a 48-position tube rack is presented according to a pick list from Excel or a LIMS system. Alternatively, specific individual tubes can be manually selected and picked via the user interface. Individual sample tubes can be picked from a single rack, or users can create a picklist to select tubes across multiple racks. Pick lists can be created by connecting the Mohawk to a Ziath whole-rack reader, such as the Mirage. The advantage in that case is that Destination racks of picked tubes can also be verified for accuracy on the same reader. Proven in installations worldwide – Mohawk tube selection and picking technology avoids the need for slow and costly robotic systems – importing a pick list, selecting, and picking larger whole tissue sample tubes in just seconds. Connecting the Mohawk 48 directly to a 2Dbarcode scanner for tube confirmation provides extra sample tracking and security. Operating in this configuration it is also possible to generate picklists directly from the tube barcodes. For further traceability, a 1D-scanner for reading the rack barcode is included as standard. For further information on the Mohawk 48 tube selector and picker please visit https://ziath.com/newmohawk48 or contact Ziath +44-1223-855021 / +31-6 431-41195 / +1-858- 880-6920 / [email protected] Founded in 2005, Ziath specialise in the development of innovative instrumentation control and information management products using 2D DataMatrix bar-coded tubes to simplify automation processes in life science organisations, from academia to the biotech and pharma industries. For further Information: MEDIA: Dr Bill Bradbury Primetek Solutions tel. +44-208-546-0869 / email [email protected] CORPORATE: Steve Knight Ziath Ltd tel. +44-1223-855021 / email [email protected] Product Launches

Microbioz India, August 2023 | 49 New robotized station aimed to develop robotic and automatic loading applications for terminal sterilization processes Telstar’s innovative station is fitted with several robots to assess the handling of stackable trays according to the type of product such as bags or bottles elstar has set up a fully automated test station to assay and develop robotic solutions for terminal sterilization applications. Intended to serve manufacturing companies in the pharmaceutical industry sector, the station is designed to conduct loading and unloading tests of their products conveyed towards an autoclave in automated sterilization processes. This station is located in the new Telstar facilities in the O40 complex in Terrassa (Barcelona). Telstar’s station is fitted with several robots to assess the handling of stackable trays according to the type of product loaded. In addition, the station is also equipped with a wide range of grippers that allow testing different types of bag and bottle formats. Designed to develop customized solutions to automate the customer's sterilization plant, from the process of stacking, transport and loading to the autoclave, as well as the subsequent unloading, adapted to the characteristics of a sterilization process for packaged pharmaceutical products. Thus, this station makes the design easier of the most appropriate complete and integrated solution for the customer in the initial phase of the investment. This system allows companies to take advantage of the inherent benefits of automated processes. These include saving on manual procedures, greater efficiency, improvement of cycle times and reduction of operational costs. This new infrastructure is complemented by the process laboratory service in the field of sterilization available for customers to develop different recipes that ensure the integrity of the container and find the optimal sterilization conditions for the product, avoiding its possible degradation, and optimizing sterilization cycles. For more information: TELSTAR Phone: +34 93 736 16 00 Website: www.telstar.com E-mail: [email protected] Merck Invests € 23 Million to Expand Cell Culture Media Production in Kansas, USA Story source/Credit: Merck Lenexa, Kansas, USA facility becomes company’s largest dry powder cell culture media facility and Center of Excellence in North America erck has announced the expansion of its facility in Lenexa, Kansas, USA adding 9,100 sq m2 of lab space and production capability to manufacture cell culture media. “The Lenexa expansion reflects our commitment to meeting the dynamic needs of our customers worldwide and delivering on our growth plans,” said Darren Verlenden, Head of Process Solutions Life Science business sector, Merck. T M Product Launches

Microbioz India, August 2023 | 50 “This expansion makes Lenexa the company’s largest dry powder cell culture media facility and Center of Excellence in North America. Investing in the region reflects our strategy to expand and diversify our supply chain to ensure we meet current and future demand for cell culture media.” Cell culture media is an essential raw material used in the manufacture of life-saving therapies and in processes as varied as vaccine manufacturing, gene therapy, and monoclonal antibody manufacturing. Because of its central role in biomanufacturing, a consistent supply of high-quality media is required to deliver the necessary concentration and protein quality for therapeutics. “Governor Kelly’s administration knows that supporting private sector efforts to strengthen supply chains benefits Kansas workers,” said David Toland, Lieutenant Governor and Secretary of Commerce, Kansas, USA. “These new opportunities offered by the Life Science business of Merck will allow even more families throughout the region to prosper.” The company’s strategic investments to expand capacity with the new dry powder media manufacturing lines in existing production facilities in the Lenexa, Kansas, and Nantong, China, sites will increase both local and global production capacity to meet current demand and ensure a robust supply for future demand surges. The company has a total of three Centers of Excellence for dry powder cell culture media manufacturing: in addition to the site in Lenexa, Kansas, serving the Americas region, and Nantong, China, for the Asia Pacific region, the third site is located in Irvine, Scotland, serving Europe, the Middle East and Africa region. About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 64,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2022, Merck generated sales of € 22.2 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. Product Launches