Microbioz India, October 2023 Laboratory edition

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Microbioz India, October 2023 | 8 25 22 12 16 20 10 18 Cover Story Precision in Every Drop: Innovations in Liquid Handling Technology Featured Article First in class drug shows promise in preclinical neuropathic pain trials Business News Alder Therapeutics set to redefine cell therapy development Product Launches Revolutionizing Bioprocessing with Imalok: The Future of Sanitary Clamps 12 16 30 38

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Microbioz India, October 2023 | 10 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. ear Readers, Welcome to the latest issue of Microbioz India. As we delve into the pages of this edition, we are excited to bring you a collection of engaging stories, insightful features, and thought-provoking content that we believe will capture your imagination and enrich your knowledge. In a world constantly in motion, Microbioz India remains steadfast in its commitment to delivering high-quality content that informs, inspires, and entertains. We take pride in curating content that reflects the diverse interests of our readers, and in this issue, you will find a wide range of topics to explore. In our cover story, we shine a spotlight on Precision in Every Drop: Innovations in Liquid Handling Technology, delving deep into its intricacies and uncovering the stories and people that make it an intriguing subject. Additionally, you'll find articles on First in class drug shows promise in preclinical neuropathic pain trials covered by LGC Mikromol that we hope will pique your curiosity. As we embrace the digital age, Microbioz India continues to evolve to provide you with fresh, interactive experiences. Be sure to check out our website for additional content, multimedia features, and ways to connect with us through social media. We value your feedback and insights, which drive us to continually improve and innovate. Your voices shape the direction of Microbioz India, and we appreciate the trust you place in us to be your source for Pharma, Bio-Pharma, Laboratory and Analytical Industry news and product launches. Thank you for your continued support and loyalty. We look forward to embarking on this journey with you, exploring the worlds within the pages of Microbioz India, and sharing the stories that make our world so captivating. Enjoy the read!

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Microbioz India, October 2023 | 12 Precision in Every Drop: Innovations in Liquid Handling Technology he attainment of high levels of precision in liquid handling technology is of utmost importance across a range of industries, encompassing pharmaceuticals, biotechnology, diagnostics, and research laboratories. The advancements in liquid handling technology have significantly enhanced the precision, effectiveness, and consistency of procedures pertaining to the transfer and manipulation of liquids. These advances have played a pivotal role in the advancement of scientific research and the augmentation of productivity across diverse applications. Here are some key innovations in liquid handling technology: Automated Liquid Handling Systems: The advent of automation has brought about a significant transformation in the field of liquid handling, mostly by mitigating the occurrence of human errors and enhancing the overall throughput. Automated systems, such as liquid handling devices and robotic platforms, provide a high level of accuracy in controlling liquid quantities, hence facilitating the execution of highthroughput operations. T Cover Story

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Microbioz India, October 2023 | 14 Variable Volume Pipettes: Variable volume variants have been introduced as enhancements to traditional pipettes, enabling users to accurately adjust desired volumes with a high level of precision. Electronic pipettes are frequently utilized, hence decreasing the potential for operator error. Multi-Channel Pipettes: Multi-channel pipettes have the capability to simultaneously dispense or aspirate many samples, resulting in time savings and enhanced efficiency. These tools possess significant value in the context of high-throughput applications. Positive Displacement Pipettes: These pipettes are appropriate for the manipulation of liquids with high viscosity or volatility. A piston is employed to displace the liquid, thereby guaranteeing the delivery process is characterized by accuracy and precision. Electronic Pipette Controllers: Electronic pipette controllers provide a reliable and uniform performance in terms of both aspiration and dispensing rates. Additionally, these devices frequently possess adaptable configurations to cater to diverse categories of liquids and their respective viscosities. Non-Contact Liquid Handling: Technologies such as acoustic droplet ejection and inkjet-based liquid handling facilitate accurate and non-contact liquid transfers, thereby mitigating the potential hazards associated with contamination and cross-contamination. Lab-on-a-Chip Technology: The utilization of microfluidics and lab-on-a-chip technologies has facilitated the manipulation of minuscule liquid volumes for a wide range of applications, including point-of-care diagnostics and DNA sequencing. Integrated Software and Data Management: Numerous liquid handling systems are equipped with software that facilitates the design and implementation of liquid handling procedures, hence ensuring precision and consistency. Frequently, these systems exhibit integration with laboratory information management systems (LIMS) to facilitate the tracking and analysis of data. Customizable Liquid Handling Protocols: The current generation of liquid handling tools provides researchers with the capability to generate and retain personalized procedures, a feature of utmost importance for investigations necessitating accuracy and uniformity. Advanced Monitoring and Calibration: Contemporary liquid handling systems frequently incorporate sensors and monitoring mechanisms in order to validate the precision of pipetting, hence mitigating the likelihood of errors. Innovative Materials and Coatings: The objective of advancements in materials and coatings for pipettes and other liquid handling instruments is to reduce sample adherence, eradicate contamination, and improve precision in liquid dispensation. Calibration and Maintenance Tools: In order to uphold accuracy, liquid handling devices are equipped with calibration equipment and adhere to predetermined timetables to assure their sustained precision. The advancements in liquid handling technologies have had a substantial influence on the precision and effectiveness of liquid transfer operations. These instruments hold significant significance in industries that place a high emphasis on accurate measurements and small quantities, such as drug development, genomics, proteomics, and clinical diagnostics. The ongoing progress in scientific developments has shown to be advantageous for researchers and laboratory experts, enabling them to attain outcomes that are more dependable and can be replicated with more accuracy in their respective fields of study. The ongoing progress in scientific developments has shown to be advantageous for researchers and laboratory experts, enabling them to attain outcomes that are more dependable and can be replicated with more accuracy in their respective fields of study. “ Cover Story

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Microbioz India, October 2023 | 16 First in class drug shows promise in preclinical neuropathic pain trials “ridiculous idea” inspired by ocean submarines has led to the discovery of a non-opioid, first-in-class drug candidate for neuropathic pain. Scientists attached a ‘chemical anchor’ to the anaesthetic drug propofol – avoiding side-effects by preventing it from penetrating the brain, but allowing it to sink into peripheral nerve cell membranes and inhibit the activity behind nerve pain. The novel drug candidate not only significantly reversed neuropathic pain signs in laboratory rats, but also had no addictive properties or adverse effects elsewhere in the body. The researchers behind the designer molecule – from Weill Cornell Medicine and the Burke Neurological Institute – believe that more ‘anchor-tethered’ drugs like theirs can now be developed for “any number” of membrane targets. Previous studies, including work published by lead researchers Gareth Tibbs and Peter Goldstein, had established propofol as a promising candidate for inhibiting the activity of HCN ion channels that play a key role in nerve pain. A Featured Article

Microbioz India, October 2023 | 17 The difficulty with targeting HCNs, however, is that they are also widely expressed in heart and brain tissues, and so any novel drug would have to be designed to “spare the cardiac isoforms and… not cross the blood : brain barrier (BBB).” Dr Tibbs’ group theorised that attaching a chemical anchor comprising a hydrophilic moiety and a carbon-based chain to an HCN1-targeted pharmacophore “could limit molecule penetration of cell membranes and the BBB while permitting or even enhancing pharmacophore access to its inhibitory site via the plasma membrane.” The group tested the novel molecule via a combination of molecular dynamic simulation, electrophysiological recordings using Xenophus oocytes, plus an array of murine studies – and found that it performed precisely as expected. The orally-administered drug prompted a 4-fold slowing in ion-channel gating and thereby significantly reduced signs of hyperalgesia in the laboratory rats after both a single dose, and seven days of dosing. In addition, it proved non-addictive, and was also “poorly, if at all, penetrant to the brain.” Developing a new class of non-opiate antihyperalgesic drugs to treat nerve pain successfully would be a significant achievement, given the huge personal and economic consequences of the condition. Drs Tibbs and Goldstein noted in their British Journal of Anaesthesia paper that around a fifth of chronic pain cases around the world are due to aberrant neuronal activity – not just blighting lives but also causing hundreds of billions of dollars each year of associated economic costs. Current treatments are, moreover, not just largely ineffective but also accompanied by “appreciable dose limiting side effects.” Named BP4L-18:1:1 because of the 18 carbon atoms in its ‘anchor’, the new drug has been likened to a molecular ‘bathysphere’ – an early 20th-century submersible lowered into the ocean on a cable. “In some ways it was a ridiculous idea,” said Dr Tibbs, “but what the current paper shows is that with the right group of collaborators, the ridiculous can become a reality. “In so doing, we believe we have created a potential clinical anti-hyperalgesic, paving the way for developing an entire class of novel therapeutics that can be built to target any peripheral membraneembedded protein of therapeutic interest.” Dr Goldstein added: “These are encouraging results, and if further preclinical studies go well, we'll apply to begin an initial clinical trial.” LGC Standards - for all your research chemical and drug discovery needs As part of LGC Standards, TRC has more than 40 years’ experience working through some of the most complex synthetic pathways to deliver you high quality research chemicals. We have a uniquely large range - including APIs, bioactive molecules and SILS, as well as synthetic chemistry tools such as building blocks, linkers, spacers and coupling molecules. LGC’s TRC range includes a significant number of pain and inflammation relevant chemicals: including agonists and inhibitors of opioid, prostanoid, cannabinoid, neurokinin receptors as well as ion channels such as HCN1-4. Can’t find what you need? Our synthetic chemics are up to the challenge! Enquire at [email protected] To support neurobiology in general, ATCC offer a large collection of in vitro tools, including NPC, Schwann cells and more than 70 brain lines. Featured Article

Microbioz India, October 2023 | 18 Reaction scale-up using flow chemistry low chemistry, also known as continuous flow chemistry or microreactor chemistry, is an excellent method for reaction profiling and optimisation, particularly prior to scale up. Using this popular synthetic technique - reagents are combined in a T- piece shaped mixer which allows diffusion across a short distance and promotes rapid and controlled mixing. The resulting laminar flow provides for excellent reproducibility. The reactions take place in microchannels which promote excellent heat and mass transfer. FlowSyn Maxi™ high throughput flow reactor The high reproducibility of results, coupled with short processing times in continuous flow chemistry, allows rapid exploration of a range of reaction conditions, making flow chemistry an idea research tool. Other benefits of flow chemistry over traditional batch chemistry systems include: 1. Higher reaction yields. 2. Better selectivity. 3. Readily scalable. 4. Improved efficiency – time and materials. 5. Reduced handling of hazardous materials One of the major benefits of flow chemistry is seamless scale-up without re-optimisation. However, output has traditionally been limited to hundreds of grams per day. Using FlowSyn MAXI high throughput flow reactor from Uniqsis, chemists are now able to scale up syntheses from grams to many kilograms in a day by utilising high flow rate pumps and large-scale coil reactors up to 100ml, with temperature-controlled static mixers essential for some reactions. Because of benefits including efficient irradiation, high reproducibility, excellent selectivity, and the ability to perform multiphase chemistry – photochemical flow synthesis is a technique gaining popularity for reaction scale-up. With growing recognition of these benefits of photochemistry synthesis, Uniqsis has, over the last few years, introduced a range of high performance photoreactors for use with its flow chemistry systems. The Uniqsis PhotoSyn™ photoreactor eliminates problems associated with traditional batch methods enabling synthetic chemists to routinely scale-up their photochemistry reactions from milligrams to several kilograms / day. F PhotoSyn™ photoreactor “ Featured Article

Microbioz India, October 2023 | 19 The PhotoSyn™ is designed to provide scientists with a high-power LED light source for continuous flow applications. To maximise safety, PhotoSyn™ has been designed to operate without any light leakage, and therefore does not require a tinted or light-tight enclosure. Safety interlocks are also fitted to prevent the possibility of accidental exposure to high intensity LED light should an attempt be made to remove the PhotoSyn™ from the reactor module whilst in operation. To learn how the University of Cambridge, UK used a PhotoSyn™ photoreactor to scale-up a photoredox cross coupling of boronic acids reaction with 81% yield please visit https://www.uniqsis.com/fcPublications.aspx About Uniqsis: 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. Featured Article

Microbioz India, October 2023 | 20 Ensure High Degree of Accuracy & Precision With XPR Analytical Balances here can be no compromise when you need accurate results. Thanks to smart quality assurance features, XPR analytical balances deliver valid results first time, every time. Seamlessly integrating into your existing information system, XPR analytical balances support the highest requirements for security, efficiency, and compliance. With a range of intelligent quality assurance functions, you can depend on XPR to deliver rightfirst-time results. The patented StaticDetect™ technology, used in combination with the optional ionizing module, offers a complete electrostatic detection and elimination system to ensure accurate weighing results and highest process security. Optional modules and accessories make it easy to customize your XPR analytical balance to perfectly fit your process needs and improve comfort of everyday weighing. Even in highly regulated environments, XPR balances integrate seamlessly into your processes. The weighing principle of METTLER TOLEDO analytical balances is based on electromagnetic force compensation. The weighing cell inside the balance housing creates a counteracting electromagnetic force to the object that has been placed on the weighing pan. The analytical balance interprets the magnitude of this compensating electromagnetic force as the weight of the object. The result is displayed on the balance terminal in the appropriate unit (grams, milligrams, micrograms, etc.). The weighing pan of an analytical laboratory balance (0.1 mg readability or smaller) is placed inside a draft shield, which protects the sample and container from external environmental influences like air drafts, improving general weighing performance. This is particularly important in analytical weighing when the accuracy of results is of the utmost importance. Analytical balances are used for simple weighing applications, as well as for standard and sample preparation, formulation, density measurement, filter weighing, etc. Eliminate Static StaticDetect measures the weighing error due to electrostatic charging and provides a warning if tolerances are exceeded. In combination with the optional ionizer, you have a unique solution that guarantees static-free weighing Right-First-Time Results The integrated StatusLight™, Level Control and GWP Approved work actively together to ensure all the relevant conditions for correct weighing are satisfied, giving you the reassurance that your results are valid. Easy Automation Upgrade Optional modules make it easy for you to quickly upgrade your balance to provide automated powder and / or liquid dosing. Automated dosing enables you to achieve a level of accuracy that is impossible to match in a manual process. Effortless Data Integrity Connect all your Excellence laboratory instruments to LabX software for full support with regulatory compliance. LabX helps you meet FDA ALCOA+ requirements for data integrity. Advantages of METTLER TOLEDO's Analytical Balances: 1. Automated Weighing – With optional powder & liquid dispensing modules, XPR analytical balances are easily upgraded to prepare samples and solutions in a fully automatic process. T Featured Article

Microbioz India, October 2023 | 21 2. Easy Cleaning – Cleaning your analytical balance is quick & easy, thanks to clever design features, such as fast release draft shields & hanging weighing pans. 3. Easy Documentation – Simplify results handling & documentation with our EasyDirect Balance data management software for Advanced & Standard level analytical balances. 4. Comprehensive Data Management – For our Excellence level analytical balances, LabX™ laboratory software takes care of all data automatically, provides centralized control, and assists with compliance with 21 CFR part 11. 5. High – Performance Weighing Cells – METTLER TOLEDO weighing cells are expertly designed & precisely engineered to deliver accurate & reliable results. 6. Robustly Built for Longevity – Metal casings, overload protection, and highquality materials ensure your analytical balance will perform reliably for many years to come. 7. Avoid the Hidden Errors Caused by Static – Our antistatic solutions help to eliminate electrostatic charges and thus prevent one of the major hidden sources of weighing errors. XPR analytical balances also have static detection technology. 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/xpr-analytical Email us at – [email protected] Call us toll-free at – 1800 22 8884 & 1800 1028 460 Featured Article

Microbioz India, October 2023 | 22 Exploring the Role of UV Vis Spectroscopy in Pharmaceutical Analysis harmaceutical analysis relies on UV-Visible (UV-Vis) spectroscopy because it can reveal details about the electronic transitions of substances. In the pharmaceutical industry, this analytical method is often used for a variety of purposes, including quality control, drug formulation, and R&D. Here’s an outline of UV-Vis spectroscopy’s role in pharmaceutical analysis: Statistical Analysis Active pharmaceutical ingredients (APIs) in medicine formulations are frequently quantified using UV-Vis spectroscopy. It is possible to precisely quantify a substance by correlating its concentration to the amount of UV or visible light that it absorbs. Quality Assurance UV-Vis spectroscopy is used by pharmaceutical firms to check the uniformity and quality of their goods. It aids in impurity detection and confirms that the drug’s composition complies with regulatory requirements. Creation of formulations By examining the solubility, stability, and interactions of chemicals, UV-Vis spectroscopy assists in the creation of therapeutic formulations. It offers information on excipient selection and medication delivery system optimization. Finding impurities Pharmaceutical impurities, such as pollutants and degradation products, can be located and measured using UV-Vis spectroscopy. P Featured Article

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Microbioz India, October 2023 | 24 For evaluations of safety and effectiveness, this is essential. Studies on drug stability Over their shelf life, pharmaceuticals must maintain stability. In order to determine a drug’s shelf life, UV-Vis spectroscopy is used to track the degradation of pharmaceuticals under various environmental circumstances. Studies on bioavailability It is crucial to comprehend how medications are absorbed and bioavailable in biological tissues. In order to support pharmacokinetic research, UV-Vis spectroscopy is utilized to monitor drug levels in blood plasma and tissues. Testing for Dissolution In dissolution testing, UV-Vis spectroscopy is used to evaluate the release of medicines from dosage forms. Understanding how a drug is released in the body requires knowledge of this. Method Validation In pharmaceutical analysis, developing and validating analytical procedures is crucial. A flexible instrument for method validation, UVVis spectroscopy ensures testing’s correctness and precision. Research and Development The study and creation of new medicinal substances depend heavily on UV-Vis spectroscopy. It assists in describing the optical characteristics of new compounds. Compliance with Regulations Data from UV-Vis spectroscopy is frequently required by regulatory bodies like the FDA as part of the application procedure for new drug clearance. In conclusion, UV-Vis spectroscopy is a flexible and essential tool in the pharmaceutical sector. It encourages the development of novel pharmaceutical products and the assurance of the effectiveness, safety, and quality of medicines. Alder Therapeutics set to redefine cell therapy development The new biotech will use its unique development approach to bring transformative cell therapies to market, starting with a promising treatment for Retinitis Pigmentosa Featured Article

Microbioz India, October 2023 | 25 Understanding Centrifuge Diagrams for Efficient Process Optimization or the optimization of numerous processes in industries like biotechnology, chemistry, and food production, understanding centrifuge diagrams is crucial. A centrifuge is a machine that divides particles or mixture constituents according to their density and size. An overview of centrifuge diagrams is shown below: Components The main parts of a centrifuge, such as the rotor, which supports the sample containers, and the motor, which spins the rotor, are often shown in centrifuge diagrams. Sample Tubes In the centrifuge, the rotor is filled with sample tubes or containers. These keep the mixture that needs to be divided. Centrifugal Force The key idea is centrifugal force, which causes particles to be pushed outward as the rotor spins. Arrows that are pointing away from the rotational center are used to depict this force. Density Gradient A density gradient is a liquid with different densities that is used in some centrifuge procedures. This might be implied by the diagram’s use of color gradations inside the sample tubes. Separation Zones The various zones or layers in the sample tubes in the centrifuge stand in for the separated components. Lighter components rise to the top whereas denser components go toward the bottom. Speed and Time Settings Centrifuge diagrams may include show settings for speed (measured in revolutions per minute, or RPM) and time, both of which are essential for obtaining the desired separation. Lid and Safety Features To ensure safe functioning, safety elements like a lid or locks are frequently shown in the diagram. Understanding how to establish the right speed and time for a centrifuge operation, as well as how to analyze the separation’s outcomes, is crucial for process optimization. F Featured Article

Microbioz India, October 2023 | 26 How Spectroscopic Techniques Enhance the Synthesis of Nanomaterials y offering important insights into the structural, chemical, and optical aspects of nanomaterials, spectroscopic techniques play a significant role in improving their synthesis. These are the ways that these methods help: Chemical Composition Analysis The elemental composition of nanomaterials can be ascertained using spectroscopy techniques such as X-ray photoelectron spectroscopy (XPS) and energy-dispersive X-ray spectroscopy (EDS). This guarantees that the nanomaterial is synthesized with the desired chemical composition. Structural Characterization The crystal structure and phase purity of nanomaterials are revealed by methods including X-ray diffraction (XRD) and neutron scattering. This is crucial for customizing their qualities because even minor structural alterations can have a big impact on how they behave. Particle Size and Morphology Information on the size, shape, and morphology of nanoparticles is available through spectroscopic analysis, transmission electron microscopy (TEM), and scanning electron microscopy (SEM). This aids in regulating and streamlining the synthesis procedure. Surface Chemistry For researching the surface chemistry of nanomaterials, FTIR and Raman spectroscopy in the infrared range of the electromagnetic spectrum are helpful. Understanding surface changes and the presence of functional groups is aided by this, which is helpful for applications like catalysis. B Featured Article

Microbioz India, October 2023 | 27 Optical Properties UV-Vis spectroscopy is used to evaluate the optical characteristics of nanomaterials, such as their emission and absorption spectra. Applications in optics, photonics, and sensing depend on this. Electronic Properties Methods like electron energy loss spectroscopy and photoemission spectroscopy can shed light on the electronic composition of nanomaterials. For applications like electronics and energy storage, an understanding of electronic characteristics is essential. Ligand and Capping Agent Analysis Spectroscopic methods can be used to locate and measure the presence of ligands or capping agents on the surface of nanoparticles. For applications using functionalized nanomaterials, this is significant. In Situ Monitoring Spectroscopic techniques that can be used in situ make it possible to monitor the synthesis process in real-time. This makes it possible to better manage and optimize the production of nanomaterials. In conclusion, spectroscopic methods are essential for assessing and enhancing the characteristics of nanomaterials, guaranteeing that they satisfy certain requirements for a variety of applications, from energy and environmental research to medicine and electronics. Featured Article

Microbioz India, October 2023 | 28 Biosimilars vs. Biologics: Breaking Down the Similarities and Differences lthough both biologics and biosimilars are significant drug classes utilized in healthcare, they differ in terms of their properties, approval processes, and price points. Here’s a breakdown of their similarities and differences: Biologics: Origin: Complex medications known as biologics are derived from living things like bacteria, yeast, or mammalian cells. They consist of medicinal proteins, vaccinations, and monoclonal antibodies. Production: The creation of biologics is a difficult and drawn-out process that involves living cells and frequently necessitates the use of specialized facilities. Patent Protection: Compared to small-molecule medications, biologics often have longer patent protection periods, which can lead to exorbitant costs and little market competition. Regulation: Biologics must pass rigorous regulatory approval procedures, including clinical studies, carried out by regulatory agencies like the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA). Interchangeability: Due to the intricacy of these medications, there is no such thing as a “generic biologic” in contrast to generic medications. The use of biosimilars is proposed as a substitute. Biosimilars: Origin: Though they are very similar to biologics, biosimilars are not exact replicas. They were created with similar safety and effectiveness in mind. Manufacturing: Producing a biosimilar requires deriving a product that is similar to the reference biologic through reverse engineering. It must have the same structure and functionality as the reference product. A Featured Article

Microbioz India, October 2023 | 29 Patent Protection: Biosimilars are released after the reference biologic’s patent protection has run out, allowing for more competition and perhaps reduced prices. Regulation: Although the regulatory approval process for biosimilars is rigorous, it is not as thorough as the procedure for the original biologic. The objective is to show that in terms of potency, purity, and safety, the biosimilar is very similar to the reference product. Interchangeability: Some biosimilars might be regarded as interchangeable with the reference biologic, which would allow users to swap them out for the original medication without visiting a doctor. Regulation-related choices may cause this to change or not always be the case. Similarities: Biosimilars vs. Biologics Therapeutic Uses: Both biologics and biosimilars are used to treat a variety of illnesses, such as chronic disorders, autoimmune diseases, and cancer. Safety and Efficacy: To receive regulatory approval, both biologics and biosimilars must adhere to strict safety and efficacy requirements. Differences: Biosimilars vs. Biologics Complexity: Compared to biosimilars, biologics frequently have more intricate structures and functions. Cost: Because biosimilars are frequently less expensive than biologics, patients may find them to be more readily available. Regulatory approach: Biosimilars do not need to repeat all the clinical trials necessary for the reference biologic, hence their regulatory approach differs from that of biologics. Interchangeability: This idea does not apply to biologics, while some biosimilars are designated as interchangeable. In conclusion, biosimilars are created as extremely similar replacements that are presented after the patent protection of the reference biologic has expired. Biologics, on the other hand, are the original, complicated drugs derived from living creatures and go through significant regulatory processes. Biosimilars offer market competition, potentially driving down prices and expanding access to these crucial treatments. Nevertheless, the procedure for regulatory approval guarantees that biosimilars are secure and efficient for patient usage. Featured Article

Microbioz India, October 2023 | 30 Alder Therapeutics set to redefine cell therapy development The new biotech will use its unique development approach to bring transformative cell therapies to market, starting with a promising treatment for Retinitis Pigmentosa lder Therapeutics, a new preclinical phase stem cell therapy development company, is set to reshape the cell therapy sector with a novel, reduced-risk approach to cell therapy development and two promising cell therapy candidates for diseases with high unmet need. The company’s lead program, a mutation-agnostic cell therapy to treat patients with Retinitis Pigmentosa (RP), is backed by strong preclinical data and is set to enter clinical trials in 2026, pending a successful funding round, which opened in September 2023. The company will be attending several conferences in October and November to discuss their new approach to cell therapy development, as well as to give more information about their current programs. Pluripotent stem cell (PSC) therapies provide hope to patients with incurable diseases. But current approaches to bringing such therapies to market are challenging. Development is often risky and poorly planned, manufacturing processes are unpredictable and costly, and income models are unreliable. In 2022, Alder Therapeutics was formed to overcome these issues and unlock the benefits of PSCs for patients across the world, using a new approach to cell therapy development that reduces risks and embeds commercial considerations at the core of development programs. Using this approach, the company is progressing a transformative cell therapy for RP — a debilitating inherited blindness disease with limited treatment options — and one for chronic heart failure. Alder Therapeutics successfully raised €3m in seed funding from Swedish investment firms Flerie and Linc based on the promising RP and cardiovascular programs, which had already generated excellent preclinical data, and the robust manufacturing methods developed. The company now aims to raise €22m to progress its RP orphan drug program through Phase I/IIa by 2026, and to prepare its cardiac program for GLP toxicity studies. “Current RP treatments are limited to one singlemutation gene therapy, with only a fraction of patients eligible,” said Kristian Tryggvason, CEO of Alder Therapeutics. A Business News

Microbioz India, October 2023 | 31 “But our retinal therapy is mutation agnostic and potentially curative, meaning it could be suitable for the majority of RP patients. What’s more, it outcompetes many other cell therapy options, having a streamlined and highly scalable manufacturing process. We’ve already demonstrated the efficacy preclinically. Now we’re looking to progress it through clinical trials to unveil its true potential in the clinic.” Ricardo Baptista, Chief Technology Officer at Alder Therapeutics, added, “We’ve crafted an entirely new philosophy to cell therapy development. Right from the start, we create robust and scalable manufacturing processes, ensure we select suitable starting cell material, and conduct commercial viability assessments to estimate ROI. And, with a virtual, agile operational structure we can tap into the best expertise to help propel us forward. With this approach, we believe we can substantially derisk the path to cell therapy success.” Alder Therapeutics will attend the following events to share more information about their highly promising cell therapy programs: 1. 23rd Euretina Congress, Amsterdam, Netherlands (5–8 Oct) 2. LSX Nordic Congress, Copenhagen, Denmark (10–11 Oct) 3. World Orphan Drug Congress, Barcelona, Spain (31 Oct–2 Nov) 4. NLS Days, Copenhagen, Denmark (29-30 Nov) To find out more about Alder Therapeutics and track the progress of their cell therapy candidates, please visit: https://www.aldertx.com/ About Alder Therapeutics Alder Therapeutics is a virtual preclinical stem cell therapy development company that is shaping the future of regenerative medicine. Founded in 2022 by three seasoned cell therapy and industry experts, the company has two promising allogeneic stem cell therapy programs in the pipeline: one for degenerative eye diseases, and one for chronic heart disease. development that keeps the commercial product in mind from the start for a de-risked route to success. Cytiva opens new manufacturing facility and experience center in India 1. The manufacturing facility in Pune will double Cytiva’s manufacturing capacity in India and the Experience Center will provide critical training programs to accelerate the development of novel therapeutics. 2. According to Cytiva’s 2023 Global Biopharma Resilience Index, the manufacturing of biologics in India is likely to increase over the next three years. s India works to become a biologics manufacturing hub, global life sciences leader Cytiva is expanding with the opening of a 33 000 ft2 manufacturing facility in Pune. The new facility will manufacture Cytiva’s bioprocessing equipment including tangential flow, virus filtration, and inactivation systems. The facility will also be home to the Cytiva Experience Center which will provide immersive training programs for upstream and downstream technologies as well as digital and automation software. Additionally, customers will have greater access to thought leadership events and to demonstrations of Cytiva’s market-leading products, such as ÄKTA, Allegro, iCELLis and Sepax. Rajan Sankaran, Commercial General Manager, India, Cytiva, says, “Fortifying our manufacturing footprint in India is critical to Cytiva’s operations in Asia-Pacific and long-term growth strategy. We must also play a key role in developing and nurturing the talent needed to meet the demand for biologic medicines. A Business News

Microbioz India, October 2023 | 32 Our Cytiva Experience Center will provide the ongoing learning and development needed to accelerate the development of novel therapeutics and help India deliver on its Aatmanirbhar Bharat vision and mission.” Located at Hinjawadi Rajiv Gandhi Infotech Park, this new facility complements Cytiva’s existing facilities in Bengaluru which include a Fast Trak Center, and a center for research and development across bioprocess, discovery, medical, and genomic medicine businesses. According to Cytiva’s 2023 Global Biopharma Resilience Index, 65% of biopharma executives in India say that the manufacturing of biologics in their country is likely to dramatically increase over the next three years. This is 15% higher than the global average, and in line with India’s National Biopharma Mission to make India a hub for the development of novel and affordable vaccines and biologics to address the population’s health concerns. Additionally, 46% of biopharma executives in India say that they are focusing on onshoring drug manufacturing or increasing domestic sourcing over the next 12 months to boost supply chain resilience. However, 20% of executives say that access to new equipment has become worse over the last two years, indicating a need to improve local access to equipment so that Indian companies can deliver affordable life-changing therapeutics domestically and to the region. ӒKTA, Allegro, iCELLis, Fast Trak and Sepax are trademarks of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva. Interested in visiting our Cytiva Experience Centre? Please contact us here. https://info.cytivalifesciences.com/experienc e-centre-india Read the full 2023 Global Biopharma Resilience Index here. About Cytiva: At Cytiva, our mission is to advance and accelerate the development of therapeutics. With nearly 16 000 associates in more than 40 countries, we’re driven to use our expertise and talent to achieve better flexibility, capacity, and efficiency for our customers. Our broad and deep portfolio of tools and technologies, global scale, and best-in-class service provides critical support from discovery to delivery, for customers spanning researchers, emerging biotech, large-scale biopharma, and contract manufacturers. Learn more at cytiva.com. New hot start isothermal mixes boost sensitivity, specificity, and speed of DNA target detection CR Biosystems, a leading PCR reagent developer, has launched a new range of Bst polymerase reagents that offer greater sensitivity, speed, and specificity in all isothermal amplification applications. IsoFast™ Hot Start Bst Polymerase and associated ready mixes use proprietary AptaLock™ hot start technology to minimise non-specific amplification, leading to highly specific and sensitive results in as little as 30 minutes. A new colourimetric mix also enables analysts to detect results visually, vastly reducing equipment requirements. With these technologies, labs can now get reliable results more quickly, unlocking higher throughput testing. Isothermal mixes are important in a range of isothermal amplification applications, including whole genome amplification, point-of-care assay development and testing, and strand displacement amplification for synthetic biology. However, a common issue with isothermal mixes is non-specific amplification — where primers bind to unintended DNA targets — because amplification often takes place at a fixed temperature which may favour nonspecific primer interactions, contrary to PCR. P Business News

Microbioz India, October 2023 | 33 Isothermal mixes can also lead to primer dimer formation, where primers associate with each other and are extended by the polymerase. To avoid these issues, users must design primers carefully, and evaluate many more primer pairs for a single target than they would for standard PCR— both of which can be extremely time-consuming and complex. To help alleviate these concerns, PCR Biosystems’ newly launched IsoFast™ reagents use AptaLock™, a reversible hot start technology that inhibits polymerase activity below 40 °C. As such, both non-specific amplification and primer dimer formation are minimised. Once the mixture is activated on heating, results can be obtained in as little as half an hour, allowing analysts to achieve highly sensitive, specific, and rapid detection of DNA targets. High-throughput testing is also possible, as reaction plates can be set up at room temperature without any issues. What’s more, the colour mix contains a pH-based dye that changes colour when the desired target is amplified. As a result, the mix enables labs to visually identify positive or negative results without the need for plate readers or fluorometric PCR instruments. The mix is therefore particularly beneficial for regions where point-of-care or fieldtesting laboratories lack adequate facilities and instrumentation. “Existing isothermal mixes present a number of challenges for organisations looking for sensitivity, specificity, and speed in DNA detection,” stated Alex Wilson, Co-founder and Business Development Manager, PCR Biosystems. “With our new mixes, labs get greatly improved specificity and sensitivity in their amplification reactions, so they obtain highly reliable results. Our internal studies show that they can be up to 50% faster than competitor mixes on tested targets too, which can make a critical difference for diagnostic and medical labs that need results quickly.” Read more about IsoFast™ Hot Start Bst Mix and Colour Mix, or request a sample today. About PCR Biosystems PCR Biosystems is a leading developer of PCR reagents for molecular biology research, diagnostics and NGS. The company offer a wide range of solutions including high-performance polymerases, thermostable reverse transcriptases, lyophilisable and air-dryable reagents and proprietary hot start technologies to maximise yield and sensitivity from the simplest to most challenging of reactions. Founded by two PCR experts in 2012, the company believes scientists deserve better performance and value from their PCR reagents. The service provided is a core priority too. Alongside a broad range of standard and custom solutions, PCR Biosystems offers free samples, bulk supply, OEM manufacturing and tailored technical support to help customers achieve the most from their marketleading reagents. In addition, as an ISO-13485 certified company, customers can have the assurance that the products developed meet the design and manufacturing standards for medical device components. Cytel continues expansion of market access and medical communication capabilities with the acquisition of co. faktor ytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co. faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. C Business News

Microbioz India, October 2023 | 34 Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support. Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization. “The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.” “Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.” To learn more about Cytel’s access advisory capabilities, please visit: https://www.cytel.com/solutions#real_world___a dvanced_analytics About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia. Business News

Microbioz India, October 2023 | 35

Microbioz India, October 2023 | 36 U.S. FDA issues 8 observations for Natco Pharma unit in Hyderabad rugmaker Natco Pharma has received eight observations following a U.S. Food and Drug Administration inspection of the company’s pharma division in Kothur, Hyderabad. The inspection was conducted from October 9-18. The company is confident of addressing all the observations within the stipulated time and working with U.S. FDA to close them at the earliest, it said in a filing on Thursday. The company’s shares closed 1.27% lower at ₹833.75 apiece on the BSE. According to Natco Pharma website, it is a formulations facility and makes oral and solid dosages, including dry powder, cytotoxic and noncytotoxic orals and cytotoxic injectables. Zydus receives USFDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus ydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg. ZITUVIO™ contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The approval of ZITUVIO™ is based on research, development, regulatory and manufacturing work performed by Zydus teams. ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIO™ is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products. "The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited. "We are pleased to be able to receive such a milestone approval for Zydus. Through our industry leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients. We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives," said Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas. According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is US$ 10 bn. About Zydus The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. D Z Pharma News

Microbioz India, October 2023 | 37 USFDA gives approval to Granules India for its delayed-release capsule to treat GERD symptoms ranules India Limited announced on Thursday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg. According to the company’s statement, it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium DelayedRelease Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcer in adults at risk for developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Aurobindo Pharma's arm gets FDA nod for hypogonadism drug urobindo Pharma on October 23 said its wholly owned subsidiary company, Eugia Pharma Specialities, received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market a drug that treats hypogonadism. The company said it has received the approval to make Testosterone Cypionate Injection USP 1,000 mg/10 mL (100 mg/mL) and 2,000 mg/10 mL (200 mg/mL) in Multi-Dose Vial and 200 mg/mL in Single-Dose Vial, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Testosterone Injection, 100 mg/mL and 200 mg/mL of Pfizer Inc. Testosterone Cypionate Injection USP is indicated replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired). The product is expected to be launched in November 2023. The approved product has an estimated market size of US$ 226.8 million for the twelve months ending August 2023, according to IQVIA. G A Pharma News

Microbioz India, October 2023 | 38 Revolutionizing Bioprocessing with Imalok: The Future of Sanitary Clamps ri clamp sanitary flange are manufactured using a Nylon reinforced with glass fiber. It is designed to use as component for single use for transfer lines in a wide range of bioprocess system. The Entire manufacturing process is carried out in clean room with cautiously controlled from raw material to finished product manufactured. Nylon sanitary flange is most popularly used in Pharmaceutical, Biotech process & Chemical industries. It is designed for connecting and sealing two pieces of process equipment, such as pipes, valves, and tanks, in a hygienic and secure manner. It is essential to select right size of clamp because it will operate effectively in a given application. Choosing right size and type of clamp will help to eliminate leakage. These clamps are ideal for securing fluid transfer with flexible process line. Nylon sanitary clamps with sanitary adapters provide a corrosion resistant solution to hygiene clamps. Ami polymer offer multiple options in ImaLOK. These are offered in a wide range of internal dimensions to meet the process requirements. 1/2”- 3/4” 1”- 1.5” 4’’ Features: 1. It is more generally used to refer to all types of hygiene connections & fittings. 2. Connected with ASME-BPE & BPSA Standard 3. Non-metallic & stainless-steel flange ferrules 4. Batch traceability is ideal for increased security & safety 5. Meets FDA requirements & 3A sanitary standard 6. These clamps are made using latest technology 7. It can be sterilized by Gamma irradiation & steam sterilization. Benefits: 1. Lightweight 2. Autoclave & Gamma sterilization 3. Easy to use- one hand needed- no tool required 4. Efficient lock 5. Biopharmaceutical grade Applications: 1. Single use system 2. Pharmaceutical & Biopharmaceutical manufacturing 3. Research Laboratories 4. Vaccine & Bio therapeutic production 5. Applications where metal is incompatible Certifications: 1. Usp Class Vi 2. Usp Class 87 3. Fda 21 Cfr 177.1500 Authored By: Sapna Phate. Officer-International Marketing. Email- [email protected] Tel no- 9512243438 T Product Showcase

Microbioz India, October 2023 | 39 Dual-cap sample collection tube for genetic testing workflows zenta Life Sciences has launched Cap2TM - a new 0.2ml PCR microcentrifuge tube featuring a novel dual-cap design with both hinged lid and screw cap to preserve the integrity of samples used in genetic testing workflows. Acting as both a collection and processing tube, sample transfer can be minimized making for greater efficiency and less wastage. Designed to ensure sample traceability in wide ranging genetic testing workflows, including preimplantation genetic testing (PGT) – each Cap2 tube has a unique 2D datamatrix code as well as a numerical human readable identifier to prevent sample tracking errors. All Azenta tubes, including the new Cap2, are developed with broad compatibility in mind, performing without compromise in conjunction with automated code reading, capping and sample management systems from Azenta and all other industry-recognized manufacturers. Manufactured from high quality virgin polypropylene, in a class 8 clean room environment, each batch of tubes is tested to certify them endotoxin and DNase/RNase free as well as containing no detectable leachables or extractables. Vital considerations for sample collection tubes used in genetic testing workflows. To learn more about how to improve sample tracking, ensure sample integrity and drive process efficiency with the Cap2 PCR tube please visit https://www.azenta.com/products/0.2mldual-cap-sample-collection-pcr-tube Azenta is a market leader in the design and manufacture of consumables and bench top instrumentation for a wide range of life science and medical applications, including research into combatting cancer and infectious diseases, drug development, molecular diagnostics, and forensics. Our leading capabilities across genomics, cryogenic storage, automation, and informatics is dedicated to sample exploration and management. We help our customers bring impactful breakthroughs and therapies to market with greater speed and precision. A Product Showcase

Microbioz India, October 2023 | 40 Dual detector for demanding GPC/SEC applications he COMBO-ONE Viscometer/DRI detector from TESTA Analytical sets a new standard for demanding GPC/SEC applications such as those focused on investigating the structure and branching of polymers. Viscometry detectors for GPC/SEC, based on four matched capillary tubes arranged in a manner analogous to a Wheatstone bridge, have been around for decades but have operational and performance shortfalls. Carlo Dessy – developer of the COMBO-ONE said “By eliminating the fundamental drawback of the traditional online viscometer design, the known ‘sample breakthrough’ after each measurement, our dual detector allows much more rapid sequencing of samples. The result of our design innovation is to increase the total daily throughput of a GPC/SEC System by a factor of two. An additional benefit of eliminating ‘sample breakthrough’ is a significant reduction of solvent required for each measurement and consequently the amount of waste produced.” He added “Another benefit of our COMBO-ONE detector is its high sensitivity and resolution. This is achieved as our differential refractometer is an integral part of the viscometer, therefore both concentration and viscosity are measured at the same time on the very same sample segment. When branching calculations and structure investigations are the goal of your GPC/SEC analysis, then resolution and sensitivity are the most important parameters users must optimize for useful results Caption: COMBO-ONE Viscometer/DRI detector (courtesy: TESTA Analytical) Caption: COMBO-ONE as part of a multi-detector GPC/SEC system The COMBO-ONE Viscometer/DRI detector from TESTA Analytical is fully compatible with all modern GPC/SEC systems. For further information please visit https://www.testaanalytical.com/gpc-sec-chromatography.html or contact Testa Analytical Solutions on +49-30- 864-24076 / [email protected]. T Product Showcase

Microbioz India, October 2023 | 41 Flowmeter Software Driver for Chromatography Data Systems ESTA Analytical announce a powerful new software driver that allows control and collection of data from any of its AB-4XXXX Series liquid flowmeters using a chromatography data system (CDS) which supports the Agilent Technologies rapid control framework (rc.NET). Software developer – Carlo Dessy said “Including real-time flow rate data with each chromatogram is a valuable aid to achieving total quality assessment of any HPLC, UHPLC, LC/MS or GPC/SEC system. Chromatography data systems are widely used in labs around the world because they include functionality that enables timesaving in the analysis, interpretation, and reporting workflows while technical controls ensure work quality, effective records management, and enhanced data security. Easy integration and full compatibility of our flowmeters with chromatography data systems is a vital requirement for them to be routinely used with liquid chromatographs by analytical labs that need the highest level of data integrity”. Using the new software driver multiple flowmeters may be connected and supported on a single CDS, each connected to a USB Port. The driver supports stand-alone, networked and Client-Server configurations. Virtual servers are supported as well, as long as they meet Testa Analytical liquid flowmeter hardware requirements. Flowmeter Software Driver for Chromatography Data Systems (courtesy: TESTA Analytical) Liquid Chromatography flowmeter (courtesy – TESTA Analytical) The rapid control technology used by the TESTA Analytical flowmeter software driver is supported by popular CDS including Agilent Technologies OpenLab, WinGPC UniChrom and Clarity systems. For further information on the new flowmeter software driver please visit https://www.customchromatography.com/technologies.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. T Product Showcase

Microbioz India, October 2023 | 42 Optimised Photochemistry module for GSM chip reactors he new PHOTOCHIP™ high power LED photoreactor module from Uniqsis provides chemists with a benchmark tool to run photochemical reactions with highly efficient mixing and accurately controlled temperature. The PHOTOCHIP™ is an easy-to-use device - design optimised to perform photochemical reactions in the complete range of Uniqsis Glass Static Mixer (GSM) reactor blocks, also known as GSM chip reactors. Accommodating either one large format or two compact format Uniqsis GSMs - chemists can choose a PHOTOCHIP™ module operating at a wavelength (365nm, 385nm, 420nm, 450nm, 460nm or 525nm) to match the excitation wavelength of their desired photochemistry. The high-power LEDs used in the PHOTOCHIP™ module require liquid cooling and, where the reaction temperature is close to room temperature, either a cold-water supply, or a recirculating system can control both the reactor and LED temperatures by connecting the respective cooling circuits in series. Caption : PHOTOCHIP™ GSM photoflow reactor with power supply (Courtesy : Uniqsis) Each PHOTOCHIP™ module has an interlock which prevents exposure to high intensity light by cutting power to the LEDs if any attempt is made to remove the light unit whilst switched 'on'. A thermal switch protects the LEDs if they are powered without adequate cooling. For more information visit www.uniqsis.com/paProductsDetail.aspx?ID=PH OTOCHIP 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 Showcase

Microbioz India, October 2023 | 43 Veolia Water Technologies launches PURELAB® Pharma Compliance Story Source/Credit: Veolia Water Technologies UK Veolia Water Technologies UK (VWT UK) has launched its PURELAB® Pharma Compliance package for those who require a reliable supply of ultrapure water (UPW) for quality control (QC) laboratories and all the necessary validation and qualification software. This new package provides everything a QC laboratory could need in a tailored, easy to use combination of equipment and services. he PURELAB® Pharma Compliance package consists of a combination of water purification equipment, software and qualification documentation. As a result, it has the potential to streamline your approach for the delivery of UPW and simplify the subsequent purified water validation guidelines and processes. Utilising a combination of UV, DI purification and ultrafiltration technology, PURELAB® Pharma Compliance is capable of delivering 18.2 MÙ ultrapure water at a flow rate of up to 2 L/min through a flexible and ergonomically designed dispenser. Developed by ELGA’s industry leading specialist team, the package is designed, manufactured and tested using a quality management system compliant with ISO 9001 and fully approved by Lloyd’s Register Quality Assurance. As a result, it will provide the required water quality to support the QC tests necessary to validate pharmaceutical purity. Easily scalable, PURELAB® Pharma Compliance can meet the needs of all laboratories – no matter their size or scale – operating under the validation conditions stipulated in either GLP, GMP and GDP. The newest addition to the PURELAB® range utilises VWT UK’s intuitive software, enabling the equipment to integrate seamlessly into any lab with no disruption to water supply or quality. Once in place, PURELAB® Pharma Compliance’s admin functions, audit trail procedures and security and data integrity capabilities all meet the global regulators best practice for data management following GMP standards. The integrated software package provides all the documentation evidence needed to meet FDA and EU standards for digital record keeping – from labs needing GLP validation right through to those that require the latest FDA 21 CFR part 11 compliance. Installation Qualification (IQ) documents and Operational Qualification (OQ) documents are also supplied as part of the standard package; in addition to purification and servicing processes support that meets the requirements of USP643 and USP645 – the only accepted method of validation of TOC reading for any system. Peter Bridge, Head of Scientific Sales at Veolia Water Technologies UK commented: “Our quality engineering and expertise will allow customers to take advantage of a practical combination of equipment and services that have been optimised with a range of features specifically for QC labs. The PURELAB® Pharma Compliance package gives you an effective and compliant ultrapure water system – with the level of validation support you want.” T Product Launches

Microbioz India, October 2023 | 44 Waters Accelerates Oligonucleotide Bioanalysis with the Launch of OligoWorks™ SPE Workflow and Kits Story Source/Credit: Waters Corporation Faster time-to-results for expanded range of bioanalysis projects enabled through enhanced LC-MS sensitivity, and standardized protocols that reduce method development and sample processing time. aters Corporation announces the launch of OligoWorks™ SPE (solid phase extraction) Kits and components to improve sample preparation for LC-MS-based bioanalytical quantitation of therapeutic oligonucleotides. Pharma and biopharma companies developing oligonucleotide therapeutics and the Contract Research Organizations (CROs) that support them can now realize up to a 2x[i] increase over competing products in oligonucleotide recovery from biofluids. The Kits deliver greater reproducibility and LC-MS sensitivity, enabling lower limits of quantitation and reducing the need for repeat experiments. The pipeline for oligonucleotide therapeutics is rapidly expanding with thirteen FDA approved oligonucleotide therapeutics today, and 500+ in the pipeline. While potent, these highly modified oligonucleotides are challenging to precisely quantify during dosing, metabolism, and tissue distribution studies. "As a leader in supporting drug development, Waters is committed to solving customer pain points, and enabling greater analytical performance and productivity. Our new OligoWorks SPE Kits directly address oligonucleotide bioanalysis sample prep challenges across diverse oligo therapeutics," said Erin Chambers, Vice President, Consumables and Lab Automation, Waters Corporation. "The science and societal effects of these therapies are exploding given their ability to address human health issues. Our workflow and kits will drive an acceleration of oligo bioanalysis projects and drug development timelines; ultimately improving the experience for drug candidates." OligoWorks SPE Kits also use an innovative, enzyme-enhanced, and detergent-free sample pretreatment that reduces washing steps and improves mass spectrometer compatibility, thus enabling direct injection LC-MS analysis and lower limits of quantitation. They can also be fully automated for improved productivity, or to simply help scientists gain back time by reducing manual steps and oversight. Available immediately, OligoWorks SPE Kits and components are another high-performance tool within the growing portfolio of Waters chemistry solutions to support oligonucleotide bioanalysis. They complement Waters best-selling MaxPeak™ Premier Columns, ACQUITY™ Premier LC System and Arc™ Premier LC System, Andrew+™ Pipetting Robot, and the class-leading sensitivity of the Waters Xevo™ TQ Absolute Mass Spectrometer. W Product Launches

Microbioz India, October 2023 | 45 Astrea Bioseparations expands manufacturing and warehousing capacity to support growing demand for its chromatography solutions in North America Story Source/Credit: Astrea Bioseparations New 12,000 sq. ft. facility in Massachusetts will increase capacity for pre-packed column products and services and create up to 15 new fulltime positions strea Bioseparations (“Astrea Bio”), a leading provider of high-quality bioseparation and purification technologies that help to improve patient outcomes with safer and more effective production of therapeutics, announces the expansion of its manufacturing and warehousing capabilities in the US. The increased capacity reflects growing demand for the Company’s chromatography solutions in North American markets. The new ~12,000 sq. ft. facility allows Astrea Bio to bring its innovative products to customers within record lead times of 3-5 weeks for off-the-shelf products, and 6-8 weeks for large-scale resin orders. The site expands the Company’s US footprint by over fourfold, supporting its continued growth trajectory as it also increases its workforce by up to 9% over an 18-month period. Completing in Q4 2023, the facility, located in Canton, Massachusetts, will provide significantly increased manufacturing and warehousing capacity. Hosting a variety of workspaces, including cleanroom laboratories for column packing services, offices, warehousing, and column assembly spaces, the facility will provide a vital hub to Astrea Bio’s North American supply network, as well as locally available technical expertise and customer support. Dedicated column packing cleanrooms will increase production capacity for pre-packed column products and services. Increased warehousing space will be available for all products, including the Company’s broad range of affinity, hydrophobic interaction chromatography and ion exchange adsorbents and resins for commercial-scale biologic production, and its AstreAdept® range of nanofiber-based purification technology for efficient production of cell and gene therapies. Astrea Bio operates a global network of offices and manufacturing facilities, to ensure reliable supply of high-quality products. The Company’s 170 employees are located at its Cambridge, UK headquarters, manufacturing facilities in Gloucestershire, UK, the Isle of Man, Joliette, Canada and Canton, MA, alongside additional office facilities in Singapore. “Expanding our presence in the US reflects growing demand for our chromatography products and services to support effective development and production of cutting-edge biologics, including cell and gene therapies,” commented Chris Brown, Operations Director at Astrea Bioseparations. “The new site gives us greater capacity to support new and existing customers by providing innovative and high-quality products, within market-leading timeframes, as well as offering local technical expertise.” A Product Launches

Microbioz India, October 2023 | 46 NEW Chilling/Heating HPLC Column Temperature Controller from 4.0°C to 100.0°C Story Source/Credit: Torrey Pines Scientific Inc Torrey Pines Scientific, Inc. announces its NEW EchoTherm™ Model CO50 Programmable HPLC Column Chiller/Heater. he unit has a temperature range from 4.0°C to 100.0°C readable and settable to 0.1°C. The PID control software regulates temperatures to ±0.2°C, even at ambient. The CO50 has a Stable Temperature LED that illuminates when the target temperature is stable to within ±0.2°C. The Peltier-based CO50 has 5-program memory of 10 steps per program and the ability to repeat any program from 1 to 99 times automatically. It is ideal for chiral and biomedical chromatography where below ambient temperatures help preserve bioactivity. It can be used for stabilizing column temperatures from day to day at or near room temperatures for repeatable results. The CO50 holds columns up to 30cm long by ¼” or 3/8” diameter in mounting clips provided. Larger diameter columns can be used by removing the column clips that hold the smaller columns. The CO50 features RS232 I/O port for controlling the unit by a chromatograph, for programming gradients, and for data collection. Also included are an injection counter, 30-day timer with user settable Auto-Off, and chamber drain for spills. The unit comes with a bench top universal power supply for use anywhere in the world, 3-wire AC line cord for the country of use, twelve-month warranty and instruction manual. The Model CO50 is ETL, CSA, and CE compliant. Shimadzu announces the release of the new AIMsight infrared microscope. Story Source/Credit: Shimadzu Maximized automation significantly improves defect analysis efficiency himadzu, one of the world leaders in analytical instrumentation and testing equipment, announces the release of the new AIMsight infrared microscope. AIMsight builds on the high sensitivity of Shimadzu’s well-known AIM-9000 to offer an improved operational experience through greater automation. AIMsight is intended for industrial applications in a variety of sectors, including drug manufacturing, materials science, electrical devices and electronics, machinery, transportation equipment, and for the environment. Industry relies on infrared microscopes An infrared microscope such as AIMsight is used by connecting it to a Fourier-transform infrared (FTIR) spectrophotometer to measure microregions using the reflection and transmission of infrared light that cannot be measured by FTIR units alone. T S Product Launches

Microbioz India, October 2023 | 47 The main applications of this are in the analysis and identification of micro-contaminants, such as those adhering to pharmaceutical pills, dirt on electronic circuit boards and microplastics. Meeting new demands with new instruments In 2016, Shimadzu introduced the AIM-9000, an infrared microscope equipped with excellent sensitivity and an automatic contaminant analysis function. Since then, the demand for measurements using infrared microscopes has grown rapidly. At the same time – and partly as a result of this – the lack of analysts with experience in such measurements has also grown. The result is that there is now a very strong demand for highly sensitive instruments capable of quick, easy and trouble-free mea-surements of smaller targets. That’s where AIMsight[2] comes in. Automatic effects AIMsight meets that demand. It easily – and, importantly, automatically – measures micro-targets by irradiating them with infrared rays and by then investigating the reflectance and transmittance. It features easy determination of the measurement range via a wide-field camera as well as by automatic identification of measurement targets, automatic setting of measurement positions and automatic analysis via a contaminant analysis program. Discover the New 410 Flame Photometer Range from Sherwood Scientific Story Source/Credit: Sherwood Scientific Ltd New 410 Flame Photometer Range now consists of the Classic, Industrial and Scientific models ll three Models of 410 Flame Photometer come with a preloaded filter stick which houses a maximum of three element filters. The filter stick is easily removed and replaced within the chimney housing (no tools required) and as such it is a relatively simple operation to introduce alternative element specific filters. Filters available for use with all Model 410’s include, Sodium, Potassium, Lithium, Calcium, Barium, Strontium, Rubidium and Caesium, the most extensive range available from any Flame Photometer Manufacturer. The Model 410 Classic Flame Photometer comes with Sodium, Potassium and Calcium filters. The “Classic” design is, in essence, the one developed by Corning some 30 years ago. We still manufacture this highly successful unit due to popular demand. The Model 410 Classic Flame Photometer has Sodium, Potassium and Calcium NIST traceable 1000 ppm standard concentrates for each of those analytes (6 x 100 ml). The Model 410 Industrial Flame Photometer with digital output, for printer or PC connection, also has Sodium linearisation capability to allow higher concentrations of Sodium (to 50 ppm) to be directly measured using a single point calibration. That facility can be switched on or off according to the operator’s preference or protocol for Sodium determinations. The Model 410 Industrial Flame Photometer has Sodium, Potassium and Calcium specific filters and NIST traceable 1000 ppm standard concentrates for each of those analytes (6 x 100 ml). The Model 410 Scientific Flame Photometer is delivered with Na, K and Li filters pre-fitted and an appropriate multi-element calibrator in mmol/l. (1 x 100ml). The Model 410 Scientific instrument is also fitted with a Digital Interface and Sodium linearisation facility allowing direct, straight line, calibration of clinically significant concentrations of Sodium, up to 200mmol/l (assuming 1 in 200 dilution), as well as Potassium and Lithium, following suitable dilution. Sherwood’s Model 806 Continuous Flow Diluter, used together with the Model 410 Scientific Flame Photometer, gives nominal sample dilution ratios of 1:200 and 1:50. It has been designed to give consistent dilution of calibrator and samples to the Flame Photometer. Both Models 410 Industrial and Scientific Flame Photometers can be further enhanced by the use of Sherwood’s Model 410 BlueNotes software and Model 865 Autosampler. A Product Launches

Microbioz India, October 2023 | 48 Fully integrated and automated systems are possible, even for the Model 410 Classic Flame Photometer via our Update and Automate Modules and packages. Biotium Introduces New Highly-Selective Stains for Both Gram-Positive and Gram-Negative Bacteria iotium, a leading innovator of fluorescent dyes for life science research, proudly announces the launch of its breakthrough BactoView™ Dead Stains and BactoView™ Viability Kits. These products were carefully designed for easy usage and improved dead cell selectivity for enhanced microbial viability determination. With precise dead cell detection being vital for accurate analysis, Biotium’s BactoView™ Dead Stains deliver significant improvements in this procedure. Unlike the traditional viability dyes propidium iodide and ethidium homodimer, Biotium’s BactoView™ Dead Stains provide brighter dead cell staining with minimal background interference. The specially-designed chemical structures of the dyes effectively exclude them from live cells of both gram-negative and particularly gram-positive strains, selectively labeling dead cells. There is only a single 30-minute staining step with no additional wash requirements for ease-of-use, with the flexibility of seven available dye colors ranging from green to near-IR for microscopy or flow cytometry analysis. BactoView™ Dead is less permeant to live grampositive bacteria than other dead cell stains like EthDIII. S. epidermidis cultures were left untreated or heatkilled, then stained with 5 uM Ethidium Homodimer III (EthD-III) or 1X BactoView™ Dead 570/585. Cells were stained in medium for microscopy or PBS for flow cytometry. EthD-III stains many live S. epidermidis cells, resulting in poor live/dead discrimination, while BactoView™ Dead allows clear discrimination between live and dead cell populations. Gray peaks: Unstained cells; Blue peaks: stained live cells; Red peaks: stained heat-killed cells. BactoView™ Dead stains also are included in two new BactoView™ Viability Kits, enabling convenient two-color staining of both live and dead bacteria for clear viability assessment of all cells in a sample. Each kit includes a BactoView™ Dead Stain, with either red or far-red fluorescence for dead cell labeling, and a BactoView™ Viability Green Counterstain for staining both live and dead bacteria. The kits are compatible with gram-positive and gram-negative strains and need only a single halfhour incubation without washing, offering both flexibility and convenience. Caption: Live or heat-killed cultures of B. subtilis stained with the BactoView™ Viability Green/Red kit and imaged by confocal microscopy. Dead cells are stained red with BactoView™ Dead 570/585, all cells are stained green with BactoView™ Green Viability Counterstain. Co-stained cells appear yellow in the merged images. B Product Launches

Microbioz India, October 2023 | 49 "These dyes and kits are a much-needed improvement for microbiological research, particularly for gram-positive stains that don’t work well with existing dead cell dyes," Biotium’s Director of Bioscience, Dr. Lori Roberts, excitedly comments. With both BactoView™ Dead Stains and Viability Kits, researchers can now attain unprecedented flexibility and accuracy in their experiments. These products grow Biotium's vast repertoire as part of our commitment to life science innovation. Features and Benefits of the BactoView™ Dead Stains Highly Selective: Vibrant staining of dead cells with minimal background. Compatibility: Works seamlessly with both grampositive and gram-negative strains. Simplicity: Requires a single 30-minute staining step, eliminating additional wash steps. Versatility: Available in 7 colors ranging from green to near-IR for diverse experimental needs. Features and Benefits of BactoView™ Viability Kits: Two-Color Staining: Labels both live and dead bacteria for comprehensive analysis. Compatibility: Works seamlessly with gram-positive and gramnegative strains. Ease of Use: Requires only a single 30-minute staining step, eliminating additional wash steps. Options: Available with either a red or far-red BactoView™ Dead Stain. For more information about BactoView™ Viability Kits, please visit the product page. Biotium also offers a wide variety of other fluorescent dyes and assays kits for staining bacteria, yeast, and fungi. Dyes for assessing cell viability and bacterial gram stain type, and a complete toolkit of reagents for microbial viability PCR are available as well. Product Launches

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