Microbioz India, February 2024 Laboratory Edition

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Microbioz India, February 2024 | 8 18 46 12 42 20 14 32 Cover Story Inside the Lab: Exploring Cutting-Edge Technologies in Pharma Analysis Featured Article Short Introduction to Extractables and Leachables in Pharmaceuticals Business News Biotium Expands Selection of Novel Nuclear Stains for Enhanced Multiplexing Flexibility for Microscopy and Flow Cytometry Applications Product Launches Certification for Liquid Flowmeters 12 44

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Microbioz India, February 2024 | 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 thoughtprovoking 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 Inside the Lab: Exploring Cutting-Edge Technologies in Pharma Analysis, delving deep into its intricacies and uncovering the stories and people that make it an intriguing subject. Additionally, you'll find articles on Short Introduction to Extractables and Leachables in Pharmaceuticals covered by LGC Standards 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, February 2024 | 12 Inside the Lab: Exploring Cutting-Edge Technologies in Pharma Analysis utting-edge technologies in pharmaceutical analysis encompass a range of advanced tools and methodologies that are revolutionizing the way drugs are developed, manufactured, and tested. “Inside the lab: A look into pharmaceutical analysis through advanced technologies” provide a comprehensive discussion on how pharmaceutical industry has recently updated its technology of analysis. Again, this section can give more information about these modern technologies. Mass spectrometry analysis: In principle, it is a process of identifying the quantity and molecular structure of substances by considering their mass-to-charge ratio. Pharmaceutical industry employs this technique in drug discovery, metabolite identification, impurity profiling, and pharmacokinetic assessment among other areas. Nowadays high-resolution mass spectrometers with improved sensitivity and specificity are able to detect trace impurities and compounds in low abundance due to advancement in ionization techniques like matrix-assisted laser desorption/ionization (MALDI) and electrospray ionization (ESI). High-performance liquid chromatography (HPLC): High-performance liquid chromatography (HPLC) is based on partitioning or adsorption interactions of sample components between two phases; stationary phase and mobile phase. C Cover Story

Microbioz India, February 2024 | 13 Applications: In pharmaceutical analysis it finds major applications such as purity assessment, impurity profiling stability testing of drug substances/formulations or quality control procedures. Advancements: Recent advances made related to column chemistry development have resulted in improved resolutions; detectors’ technology has also undergone significant improvements leading to enhanced sensitivities whereas chromatographic methodologies have been modified so as to be faster than before. Besides, combining HPLC with mass spectrometry (LC-MS) enables qualitative as well as quantitative capabilities of detection. Nuclear Magnetic Resonance (NMR) Spectroscopy: Principle: NMR spectroscopy reveals molecular structure dynamics and interaction depending on magnetic nuclei interaction with external magnetic field Applications: Pharmaceutical uses include structural elucidation stereoisomer characterization, formulation characterization, and quality control. Advancements: There are new NMR instruments that have been introduced in recent times which include higher magnetic fields, cryogenic probes as well as multidimensional NMR techniques leading to increasing sensitivities, spectral resolutions and acquisition rates thereby making analysis of complex pharmaceuticals more efficient and accurate than it was before. Ion Mobility Spectrometry (IMS): Principle: The separation of ions based on the size, shape and charge using IMS in gas phase yields structure related information and enables a quick analysis of complex mixtures. Applications: The use of ion mobility spectrometry includes drug screening, impurity detection, counterfeit detection and formulation analysis for pharmaceutical purposes. Advancements: Miniaturization; hyphenation with other analytical techniques such as mass spectrometry (MS), improved data analysis algorithms among others have made this method find extensive application in pharmaceutical analysis by providing quick results with high sensitivity for detection of pharmaceutical compounds including their metabolites. Raman Spectroscopy and Surface-Enhanced Raman Spectroscopy (SERS): Principle: Photon scattering from molecules involves vibrations or rotations of these molecules giving qualitative or quantitative analytical information obtained through Raman spectroscopy. Applications: The use of Raman spectroscopy/SERS involves identification of raw materials used in production process, polymorph characterizations, counterfeit detection and monitoring real-time processes involved in drug production within the affected companies especially those found below the poverty line. Advancements: Over the past few years there have been improvements in raman instruments such as handheld devices which are portable while confocal raman microscopy has made the technique possess a better spatial resolution; besides SERS has led to an increase sensitivity towards various types analyses as well as it has enhanced versatility so far whereby nondestructive investigations were carried out on numerous different forms when concerning about drugs available at pharmacies. Automation and Artificial Intelligence (AI): Principle: Automation and AI technologies streamline analytical workflows, enhance data processing capabilities, and enable predictive modeling and decision-making. Applications: They are utilized in pharmaceutical analysis for interpretation of data, optimization of methods, quality assurance, design of experiments in drug development, and prediction during drug discovery stages. Progress: In this process, the merging of robotics, laboratory automation platforms, machine learning algorithms, and predictive modeling software has speeded up pharmaceutical analysis workflows, reduced human error rates and encouraged databased judgment making thus leading to shorter drug development timelines alongside better product quality and safety. This integration enables pharmaceutical researchers and analysts to understand more about the molecular properties, behaviors and interactions of drug compounds which in turn will enhance the development of safer medications that are more effective hence facilitating personalized healthcare delivery for patients. Cover Story

Microbioz India, February 2024 | 14 A Short Introduction to Extractables and Leachables in Pharmaceuticals Extractable and leachable (E&L) impurities can occur when drug products interact with a wide and complex range of packaging, drug delivery, and manufacturing components. But a lack of internationally-agreed guidance on E&Ls is hampering our efforts to understand them. Fortunately, this situation looks set to change in the near future - with positive developments on ICH 3QE, the International Council for Harmonization’s proposed new E&L guideline, as well as the US Pharmacopeia’s work on developing new system suitability standard mixtures under USP-NF49(4). xtractables and leachables are an impurity subset resulting from the interaction of pharmaceutical products with their packaging, drug delivery systems, and manufacturing components. Common E&Ls include plasticisers, antioxidants and Polycyclic Aromatic Hydrocarbons (PAHs), and they can migrate from numerous sources into a dosage form. An extractable may be defined as a substance that can be ‘pulled out’ of devices, components and packaging materials using deliberate ‘stressing’ conditions – such as strong solvents, high temperatures, and increased surface area. Leachables, meanwhile, are substances that are “released under the gentler conditions of on-shelf storage.” Extractables are also regarded as representing “the worst-case scenario” in terms of impurities that can be released from manufacturing and packaging components, while leachables mostly – but not always - represent a subset of chemical species that can be extracted. The purpose of attempting to identify potential E&L impurities is “to determine the impact to human health and/or drug efficacy that those chemicals pose.” E Featured Article

Microbioz India, February 2024 | 15 Perhaps the main negative effects that a leachable can have on a pharmaceutical product stream are 1) that it is toxic, and thus poses a risk to consumers; 2) that it interacts with the drug and alters its stability or potency; or 3) it interferes with an assay that measures the drug’s essential properties. Extractable and Leachable Sources The very complex processes involved in producing packaging materials, drug delivery systems, implantable medical devices, and bioprocess materials mean that E&L impurities can derive from multiple potential sources. Amongst these are packaging materials such as vials, foils, inks, and coatings, as well as production components like bags, tubing, and filters. An additional risk factor is that many of today’s manufacturing components are made from singleuse plastic and elastomeric materials – the nature of which can significantly increase potential exposure to extractables, or lead to “a much greater chance of having... leachables with direct health risks .” Risk assessment and analysis Experts agree that, given the “plethora of component parts used during product manufacture and storage”, and the large number of potential leachables, “a structured and thorough E&L study” is essential to guarantee the safety and efficacy of each drug product. Due to the many different types of materials used during production, such studies must also be tailored to the specific product to ensure accurate assessment. One way of ensuring that all risks are covered is to take a Quality By Design (QBD) approach to E&L studies, based on a thorough understanding of the manufacturing process, from sourcing of raw materials to disposal. The purpose of the extractables study is then to identify compounds that could migrate into the pharmaceutical product upon storage under normal conditions, and establish “a baseline for the following leachables study, a series of tests carried out at predefined time-points on the pharmaceutical product for the duration of its shelf-life.” The drug product is screened in order to discover, identify and quantify leachables, which can then themselves be assessed for their potential adverse effects in a chemical safety risk assessment – a process that compares a consumer’s exposure to individual leachables with toxicologically established exposure thresholds. Analysts will also refer to general E&L risk considerations, such as those set out in USP 1664, which classifies the likelihood of interaction between packaging components and dosage forms based on the drug’s route of administration. Meanwhile, to generate a complete leachables profile, “an analytical strategy involving multiple, orthogonal analytical methods is necessary” – including qualitative screening by GC-MS and/or LC-Q-TOF. For quantitative leachables testing, GC/MS, TDS-GC MS/MS and GC-FID can all be employed for volatile/semi-volatile impurities; while UPLC-UV/MS/MS, HPLC-UV/PDA-FLD and LC-Q-TOF are suitable for non-volatiles. Ion chromatography is, meanwhile, useful for the analysis of anionic impurities, with ICP-MS and ICPOES preferred for elemental impurities. ‘Disconnected’ regulations There are currently no safety-based International Council for Harmonisation (ICH) guidelines specifically addressing E&Ls, as general guidance papers on impurities in pharmaceuticals (ICH Q3A-C) focus primarily on impurities caused during drug synthesis and degradation, or by residual solvents. Although they make reference to “extraneous contamination that should not be present” and should be controlled by good manufacturing practices, these documents do not directly address extractables or leachables. Published in 1999, the US Food and Drug Administration (FDA) Guidance for Industry on Container Closure Systems for Packaging Human Drugs and Biologics still offers some of the most specific advice available to laboratories on E&Ls, although some observers have criticised its “very general” risk assessment advice on leachables, as well as its failure to discuss further purification steps. In 2013, the US Pharmacopeia published general chapters 1663 “Assessment of Extractables” and 1664 “Assessment of Leachables”, which establish critical dimensions for extractable and leachable assessments respectively. However, neither chapter establishes specific analytical methods, extraction methods, leachable specifications or acceptance criteria for any dosage form, packaging system or drug product combination. Featured Article

Microbioz India, February 2024 | 16 In addition, USP 661.1 “Plastic Materials of Construction” and 661.2 “Plastic Packaging Systems for Pharmaceutical Use”, provide bases for the assessment of “established tests and acceptance criteria to ensure packaging systems do not materially impact the effectiveness of the drug product”. Both chapters become official guidance on December 1, 2025. Despite the existence of the advice above, many within the E&L testing community believe that “Extractables and leachables risk assessments, testing, and safety-based limits, have become disconnected from other relevant impurity initiatives, particularly ICH M7, ICH Q3C and ICH Q3D.” Specifically, they would like to see E&L regulations based on metrics such as Permitted Daily Allowances (PDEs) and Thresholds of Toxicological Concern (TTC) – arguing that the current system of assessing leachables against a Safety Concern Threshold (SCT) is “an overly conservative approach”, which “wastes time, money and effort” and reduces industry efficiency. Significantly, this view appears to be shared within the ICH, which also stated in 2020 that a lack of internationally harmonised guidance on E&Ls “generates uncertainty for industry and regulators.... (and) ultimately creates potential delays in the approval of regulatory applications, (which) can lead to variable interpretation (and) may cause delays in the accessibility of medicines to patients.” It has therefore tasked a committee of experts with drafting new guidelines that specifically address E&L issues. Known as ICH Q3E, the committee's final guidance paper is expected to be published by November 2025. ICH Q3E – closing the guidance gap The committee's 2020 concept paper anticipates that ICH 3QE’s scope will include: “chemical, biological and biotechnicological products, including drug-device combination drug products” – but not medical devices. It will, however, include “all associated dosages forms and take into account the extracting/leaching conditions, the route of administration, drug indication and patient exposure.” The concept paper also sets out a series of key E&L issues it hopes to resolve with the introduction of the new guideline, including: 1. Agreeing a global ICH guideline for E&Ls, “to harmonize current expectations covering all medicines, allowing clearer definition of scope and focus on critical quality and safety aspects.” 2. Developing principles for E&L control strategies and studies, based on science and risk-based principles for container closure and manufacturing systems, plus drug delivery device components. 3. Introducing harmonised, futureproofed, thresholds for reporting and identifying E&Ls and qualifying leachables, in the context of route of administration, drug indication and patient exposure. 4. Establishing safety limits taking into account route of administration, drug indication and patient exposure, and agreeing a common strategy for additional safety studies. 5. Investigating additional options for mitigating and controlling processderived leachables. 6. Using existing principles to align Q3E with current ICH impurity guidelines (ICH 3-7 and M7). 7. Aligning existing national and regional E&L standards under a new guidance framework. USP-NF49(4) - further improving standards In another sign that the international testing community is becoming more aligned in its approach to E&L issues, a US Pharmacopeia Pharmaceutical Forum published a stimuli article in July, inviting comments on its proposals to develop system suitability standard mixtures supporting the screening of organic E&Ls. Featured Article

Microbioz India, February 2024 | 17 The article provided details of the proposed mixture’s performance using HS-GC/MS, GC/MS, LC/MS-APCI and LC/MS-ESI, and also discussed next steps in the project: including feedback from stakeholders, revisions to the mixtures, qualifying batches of the materials as reference standards, stability assessments, and the development of additional mixtures LGC Standards – for all your E&L testing needs LGC Standards provides a large portfolio of reference materials and research tools for extractable and leachables – enabling you to have confidence in the integrity of both your results and the safety of your products. Why not browse a selection of our USP 661.1-related products below, or see our full extractables and leachables range? USP 661.1 Related Substances Standard USP 661.1 Featured Article

Microbioz India, February 2024 | 18 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 Co-operation 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. G Featured Article

Microbioz India, February 2024 | 19 Your Benefits 1. The accuracy of your weighing instruments is matched to your process tolerances. 2. A comprehensive summary report provides an overview of the status of all weighing equipment. 3. An optimized routine testing and calibration schedule results in sustainable cost savings. 4. 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 Featured Article

Microbioz India, February 2024 | 20 Laboratory 4.0 & Liquid Chromatography n the world of analytical chemistry, liquid chromatography stands as a cornerstone technique, enabling scientists to separate, identify, and quantify components with unparalleled precision. As technology continues to advance, so too does the field of liquid chromatography, ushering in new capabilities and possibilities. To shed light on the latest innovations and emerging trends in this dynamic field, we had interaction with Carlo Dessy, Managing Director of Testa Analytical Solutions eK, a respected developer of liquid chromatographic instruments, related detectors and software. Please tell our readers about the concept of Laboratory 4.0. We are in the early stages of an exciting workplace transformation where digital technologies connect automated processes and equipment, monitor, and control supply chains, and work alongside automated systems programmed to leverage artificial intelligence (AI). This transformation, known as ‘digitalization,’ enables you to use digital technology to collect data, establish trends, automate processes, and make better business decisions. In scientific labs the application of these principles is often referred to as Laboratory or Lab 4.0. What are the driving forces for this next generation of smarter, networkable lab equipment and automated workflow tools? Lab 4.0 has the potential to accelerate innovation by streamlining and automating processes and enabling more insightful data analysis. Successful digitalization within a laboratory requires connecting as many processes, instruments, people, systems, and consumables as possible. Using this connected laboratory framework, you can build automated end-to-end workflows that accelerate science and improve productivity. Connected technologies can reduce or even eliminate some of the repetitive, manual work that scientists and technicians need to carry out. If scientists conduct experiments using connected instruments, data can be instantly fed into a laboratory information management system (LIMS). This removes the need for manual data input or transfer, and reduces the risk of transcription errors, improving data quality. With connected technologies you can access, manage, and report data in real-time throughout laboratory workflows, rather than just at the end. This can be particularly important in highly regulated environments, where every process must comply with good manufacturing practice (GMP). I Interview Caption: Real-time flow monitoring of HPLC systems

Microbioz India, February 2024 | 21 By connecting everything to a LIMS it becomes possible to manage, track and report on samples, tests, and test results at every step, from raw material analysis through to finished product, supporting auditing requirements and making it easier to demonstrate compliance. Finally, the improved data quality and integrity achieved through connectivity provides a robust foundation for more advanced analytics. What technologies do you think will have the largest influence on these developments? Any kind of machine intelligence requires reliable input signals or information in order to operate correctly. These inputs must fulfil by themselves a set of requirements in terms of reliability, function, and self-diagnostics in order to deliver useful information. A new generation of intelligent sensors capable of supplying information which can be directly used without any further processing will be an integral part of achieving the benefits of Lab 4.0 systems. Are current generation liquid chromatography systems equipped to master this evolution? Real-time monitoring of solvent flow, detection of air bubbles, and even auto identification of the solvents used are fundamental parameters that any liquid chromatography system which targets to fit in the lab 4.0 philosophy should ideally deliver. In my opinion, no commercial liquid chromatography system is currently fully equipped for this challenge. I have recently noticed small steps in the right direction for manufacturers of the next generation of HPLC, UHPLC and GPC/SEC systems to have more intelligence built in. What experience does TESTA Analytical have in developing next generation Laboratory 4.0 automation tools? Most manufacturers still rely on a simple measurement of pressure for assessment of presence of flow in their HPLC systems. Unfortunately, this gives you only a limited view of what is really going on. A few years ago, TESTA Analytical started an R&D program to create intelligent sensors for monitoring and validating in real-time the performance of liquid chromatography systems. The first intelligent sensors we produced were simple sensors capable of detecting critical levels of solvent in a reservoir or waste bottle. We then moved onto the more challenging task of noninvasive measurement of flow rate of any solvent commonly used in HPLC. This development resulted in a family of real-time flowmeters capable of covering the range from micro flow to preparative flow rates. More recently we launched a powerful, yet easy-to-use software tool capable of integrating data generated by our flowmeters into chromatography data systems from several different manufacturers. This data integration represents an important step into Lab 4.0 as it allows validation of each single chromatogram produced by your HPLC system and documentation of flow data alongside the data obtained by the detectors of the system. Interview Caption: Next generation flowmeter software driver for HPLC systems

Microbioz India, February 2024 | 22 Please describe a typical custom product development by TESTA. Our custom product development business arose from instrument companies enquiring about TESTA’s willingness and ability to rapidly develop and deliver optimized versions of our GPC/SEC and HPLC detectors for their particular application challenges. What is our product development process is a question we are asked frequently and typically discuss at length? For the context of this interview, I will try to condense my answer to a few sentences. We always start by asking the customer the goal of their planned product development. This might sound very simplistic but product definition by itself is complex as it involves multiple considerations ranging from technical, administrative, and financial to market and competitors. We therefore take great care to discuss all these matters with our clients to ensure the best possible target product definition. Once the product is defined, we then can check our detector module portfolio to see whether components we already have in repertoire might be adapted. This has a number of advantages in technical, financial and time terms. If we have an existing detector module that can be adapted - we then work to produce a prototype that demonstrates proof of function. Once proof of function is demonstrated we work to shape the prototype into a reliable product backed by the necessary technical and service documentation. Ultimately the success of our client’s new product is our success. This is our motivation. This is why we want to supply customers with the best possible solution for their application or process, using the most advanced technology, designed for reliable long operation at a price that enables the product to be competitive. We never take shortcuts or make compromises in our custom product developments as ultimately this is a path to an unhappy customer. About Author: Carlo Dessy is Managing Director of Testa Analytical Solutions eK, a respected developer of liquid chromatographic instruments, related detectors and software. He may be contacted on [email protected] Interview

Microbioz India, February 2024 | 23 Revolutionizing Bioprocessing: The use of SingleUse 2D, 3D Bags, and Liners ingle-use bioprocessing bags are increasingly favored over stainless steel vessels, addressing issues of corrosion, cleaning, sterilization, cost, weight, and handling. With the introduction of single-use 2D and 3D bags, they bring revolutionary changes—providing convenience, scalability, and reduced crosscontamination risks, while eliminating cleaning and sterilization needs, using high-quality flexible materials for bioprocessing advantages. Current market and future demand: The market size was valued at $ 2.8 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.20% from 2023 to 2029, reaching nearly $ 4.8 billion by 2029. (Source: www.maximizemarketresearch.com) Growth factor for ongoing demand of single use bioprocessing bags: The bioprocess bags market is experiencing significant growth due to the increasing demand for biopharmaceuticals, advancements in bioprocess technology (single-use systems, disposable bags), and the rise of modular manufacturing. Additionally, the impact of the COVID-19 pandemic and the demand for personalized medicine further drive the need for 2D and 3D bioprocess bags in biopharmaceutical manufacturing. Single use bioprocessing bags market. The global bioprocess bags market is characterized by strong consolidation, with major industry players dominating sales. However, Ami Polymer has emerged as a notable manufacturer of 2D and 3D single-use bioprocess bags. Ami Polymer offers high-quality single-use bags and liners manufactured and packed in ISO Cleanroom Class 7, catering to biopharmaceutical processes like vaccines, antibodies, gene and cell therapies. Our single-use bags are made from 9101 RENOLIT Infuflex film, exhibiting low extractable, low precipitation, excellent physical strength, chemical compatibility, biocompatibility, and meeting diverse storage and transportation requirements in biopharmaceutical processes. S TYPES OF BAGS (2D, 3D & LINERS) Featured Article

Microbioz India, February 2024 | 24 Applications: Buffer and Media storage| Cell Culture| Cell Separation & Harvest| Chromatography Feed & Collection| Ultrafiltration & Difiltration Capacity: Certification: Film Composition/Specification: Featured Article

Microbioz India, February 2024 | 25 Using Ion Exchange Chromatography to Purify Proteins roteins can be separated according to their net charge using the potent protein purification method known as ion exchange chromatography (IEC). Ion exchange chromatography can be used to demystify protein purification in the following ways: The Ion Exchange Chromatography Principle: The variations in net charge determine the protein separation of IEC. There are charged groups, either cationic or anionic, bonded to a solid support in the stationary phase. Proteins with opposite net charges to those in the stationary phase are retained, whereas those with similar charges flow through quickly. Sample Preparation: Adjust pH and ionic strength to optimize protein stability and solubility during sample preparation for interaction with the ion-exchange resin during chromatography. Equilibration of the Column: Prior to sample application, equilibrate the ionexchange column using buffer at pH conditions compatible for protein binding as well as ionic strength conditions. Sample Loading: Put prepared protein sample onto ion-exchange column in conditions promoting binding of target protein to resin; monitor elution absorbance or conductivity for tracking protein elution Washing: Use buffer solution for washing out unbound proteins and other contaminants from the column while retaining target proteins in its resin. Elution: Altering buffer conditions such as pH or ionic strength cause elution of bound proteins leading to disruption of interactions between these molecules and resins thereby releasing bound target protein collect fractions containing desired protein based on absorbance or conductivity measurements. P Featured Article

Microbioz India, February 2024 | 26 Analysis of Fractions: Assess purity and yield by analyzing eluted fractions using techniques like SDS-PAGE or spectroscopy Pool together only those fractions containing purer forms that have a target protein for further downstream applications. Regeneration of the Column: After every use, wash with proper solutions that remove bound proteins and regenerate resin for subsequent purifications Troubleshooting: During purification process, such as poor binding, excessive column backpressure or protein aggregates, monitor flow rate, column pressure and elution profile in chromatography parameters. Scale-up: While retaining a consistent purification performance and protein yield it is necessary to scale up the purification process when dealing with larger sample volumes. Understanding the principles and best practices of ion exchange chromatography will enable you to purify proteins with high yield and purity for various downstream applications in biochemistry, biotechnology and pharmaceutical research. Featured Article

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Microbioz India, February 2024 | 28 The Science Behind the Wobble Hypothesis Explained NA wobble hypothesis gives a molecular biology explanation of the interpretation of genetic code during protein synthesis. The clarification of how one tRNA molecule can recognize more than one codon in the course of translation is given by the wobble hypothesis, formulated by Francis Crick in 1966. Science behind Wobble Hypothesis: Genetic Code and Codons: It is a set of rules that determine which amino acids are coded for by each codon during protein synthesis in a genetic code comprising other things. The triplet of nucleotides in messenger RNA, namely codon, dictates which amino acids are coded for by the 64 different varieties of codons or marks the beginning and end of translation. Transfer RNA (tRNA): During ribosomal complex translation, tRNAs serve as intermediaries between mRNA and proteins. These molecules, attached to specific aminoacyl-tRNA synthetases, take specific amino acids and add them to growing polypeptide chain. They pair with the right codon on messenger RNA because they contain anticodon sequences at both ends. Degeneracy of Genetic Code: It’s known as degenerate because it’s possible for several different codons to specify one particular protein component. For example, six codons correspond to leucine: UUA, UUG, CUU, CUC, CUA and CUG. Non-Watson-Crick Base Pairing in Third Codon Position: The third position (5′ end) of anticodon(tRNA) and first position (mRNA) within third positions(mRNA) are involved in nonstandard based pairs like G-U or I-containing pairs since those A-U and G-C pairing rules at antiparallel Watson-Crick interaction between codonanticodon interactions appear relaxed in respect to relaxed Watson-Crick interaction at antiparallel complementary RNAs. D Featured Article

Microbioz India, February 2024 | 29 Role of Inosine(I): A modified nucleotide present within some tRNAs’ anticodon loop at first position is inosine. With a single tRNA containing inosine at the anticodon, binding to multiple codons that only differ by the third position could be facilitated: for example, an anticodon sequence of 5′-I-C-A-3′ would allow binding of a tRNA to both UAU and UAC codons which code for tyrosine as inosine can pair with either A or C at third codon position. Efficiency and Accuracy of Translation: The wobble hypothesis decreases the number of tRNA molecules necessary for interpreting all possible codons per amino acid thereby promoting translational efficiency. Moreover, it prevents errors due to mismatched codon-anticodon pairing during translation. In short, wobble hypothesis explains that tRNA detects similar but slightly different combinations of triplet codes thus extending protein synthesis possibilities by expanding genetic code variety through translation. Featured Article

Microbioz India, February 2024 | 30 The Science Behind the Functionality of a Laboratory Water Bath everal scientific principles, such as temperature control, heat transfer and thermal equilibrium form the basis of the functionality of a laboratory water bath. Therefore, understanding these principles is important in order to use it well and optimize its performance in various laboratory operations. The following is a breakdown on how it works scientifically: Heat Transfer: The working of a water bath is based on an essential process called heat transfer. Turning the water bath on allows energy to be passed from the heating element located at either bottom or side edges of the bath to the water contained thereby leading to rise in its temperature. This can occur through conduction, convection or radiation. Conduction: There’s transfer of heat from heating element directly to water molecules which are in contact with it. These molecules then laterally pass on heat through collisions with adjacent ones leading to progressive heating up of whole-body volume. Convection: When close to heater water expands thus becoming less heavy whereas colder one falls down taking its place. By that way there appears natural movement within bathing area providing better distribution of warmth and making possible for even temperature everywhere. Temperature Control: Energy supplied by a power source into a water bath can be regulated using temperature control mechanisms so that desired setpoint can be reached and maintained accordingly. Usually this involves thermostat or temperature controller connected with heating element. S Featured Article

Microbioz India, February 2024 | 31 Thermostat: It controls different temperatures which are being set by adjusting degrees depending on whether they want higher or lower amounts when dealing with liquid amounts like this one here now used mainly has computerized thermoregulation technology allowing accurate regulation at given values. Thermal Equilibrium: Water bath attains thermal equilibrium when uniformity sets in throughout its volume and desired set point becomes stable; thermal equilibrium ensures consistency as well as reproducibility during experiments conducted under similar conditions. Insulation: To minimize losses due to convection, insulation materials surrounding the outer surface help conserve heat hence informing energy efficiency while minimizing fluctuations in temperatures experienced by water baths. Examples of insulation materials include doublewalled construction, foam insulation, and reflective surfaces. Evaporation and Condensation: Water baths are subject to evaporation especially at higher temperatures. This can lead to reduction in the water volume and change in concentration of dissolved substances. Sometimes, covers or lids may be used with some water baths so as to minimize evaporation as well as keep sample intact. Safety Features: Safety measures such as overheating protection and low-water level detection avoid accidents or destruction of instruments or specimens; this is important for safe operation of laboratory’s water bath. Therefore, researchers who know these scientific principles that underlie how a lab water bath functions are able to optimize its use hence precise temperature control, even heating and consistent experimental outcomes in different scientific application areas. Featured Article

Microbioz India, February 2024 | 32 Biotium Expands Selection of Novel Nuclear Stains for Enhanced Multiplexing Flexibility for Microscopy and Flow Cytometry Applications Greater selection of NucSpot® Nuclear Stains promotes further precision, efficiency, and reliability in cell imaging with selective nuclear targeting and exceptional photostability iotium, a leader in fluorescent dyes for life science research, announces the expansion of its NucSpot® Nuclear Stains lineup, offering unprecedented specificity and flexibility for nuclear counterstaining. NucSpot® Nuclear Stains are membrane-impermeant, targeting the nucleus selectively with minimal fluorescence until binding to DNA, enabling convenient no-wash nuclear staining. Unlike traditional options such as propidium iodide (PI), TO-PRO®, or TOTO®, NucSpot® achieves nuclear specificity in fixed and permeabilized cells without the need for RNase treatment. Now with an extensive selection of 9 colors spanning the fluorescence spectrum from green to near-infrared (near-IR), NucSpot® Nuclear Stains provide greater panel flexibility, compatible with FITC, Cy®3, PE, Texas Red®, Cy®5, APC, Cy®5.5, and Cy®7 channels. Several options are non-toxic, suitable for cell cycle profiling by flow cytometry, and can be incubated in live cultures for multi-day imaging. "These new additions to our cellular stains line provide a major improvement by broadly expanding scientists’ color choice for nuclear counterstaining. Plus, NucSpot® Nuclear Stains are much more photostable than existing cyaninebased nuclear stains, and there’s no need to treat with RNase for nuclear staining." says Dr. Lori Roberts, Director of Bioscience at Biotium. "These novel dyes are products of our commitment to providing cutting-edge and convenient tools for cell biology research." Features and Benefits of NucSpot® Nuclear Stains 1. Bright & Specific: Selective nuclear counterstains with exceptional sensitivity. 2. Versatility: Suitable for fixed cells or dead cell staining in live cultures. 3. User-Friendly: No-wash, no RNase staining protocol for efficient and consistent results. 4. Exceptional Photostability: Maintains excellent imaging quality during prolonged sessions. 5. Wide Color Selection: Available in 9 colors for flexible panel design. 6. Validation and Quality Assurance: Rigorous in-house testing guarantees reliability and consistency. For more information about NucSpot® Nuclear Stains, visit the product page. B Business News

Microbioz India, February 2024 | 33 About Biotium Biotium is a leading life science reagent manufacturer and supplier devoted to facilitating scientific discovery with high-quality and innovative fluorescent tools. At the forefront of fluorescent dye design, our collaborative team of expert chemists and biologists applies chemistry-based principles towards solutions for unmet challenges in life science and medical research. Since its founding in 2001, Biotium has developed over 30 patented technologies that have been licensed to global leading life science technology companies. ENPICOM partners with Erasmus University Medical Center in groundbreaking effort to discover nanobodies against cancer Erasmus University Medical Center uses ENPICOM’s IGX Platform and services to advance their research on identifying cancer nanobodies NPICOM, an innovative bioinformatics software solutions provider, has announced a collaboration with Erasmus Medical Center, Rotterdam, a distinguished leader in cancer research. The aim of this partnership is to identify and develop nanobodies against cancer by utilizing ENPICOM’s immune repertoire data analysis services and software solutions. "We selected ENPICOM to support our project because of their unique software that is specifically designed for antibody discovery workflows and their ability to operate as an extension of our team," said project lead Dr. Guido Jenster, professor of Experimental Urological Oncology at Erasmus MC. "By combining the strengths of our team and ENPICOM's expertise, we are wellpositioned to make significant progress in our pursuit of discovering novel cancer therapeutics." The collaboration is funded by the Ministry of Economic Affairs by means of the PPP Allowance made available by the Top Sector Life Sciences & Health to stimulate public-private partnerships. "We are excited that Erasmus MC, a distinguished leader in cancer research, has chosen ENPICOM to advance the frontier of nanobody-based treatments.” stated Paul van der Velde, CEO at ENPICOM. “Nanobodies hold immense potential as a transformative tool in cancer therapy.” Compared to traditional antibodies, nanobodies are much smaller, enhancing tissue penetration and tumor infiltration. Moreover, nanobodies tend to have longer CDR3 regions, enabling them to better recognize hidden epitopes. E Business News

Microbioz India, February 2024 | 34 Their simple single-chain structure also grants nanobodies greater stability and ease of production and engineering. ENPICOM’s IGX Platform is specifically designed to analyze antibody sequencing data and discover a diverse set of developable candidates. The software seamlessly integrates sequence and experimental assay data, allowing for efficient cluster, phylogenetic, and display enrichment analyses in a secure and scalable environment. Moreover, to ensure the best antibody candidates are selected for follow-up studies the platform enables highthroughput structural modeling of antibodies to accurately identify and annotate exposed liabilities. This makes it a powerful solution to streamline any antibody discovery workflow and easily identify the best antibody candidates for further development. In addition to the IGX Platform, ENPICOM offers full-service immune repertoire sequencing and analysis in collaboration with Cerba Research. Furthermore, ENPICOM offers on-demand repertoire analysis and custom development to support non-standard R&D – a solid combination of immunology, bioinformatics and software engineering to take on anything touching adaptive immune repertoires. ENPICOM Media Contact Svitlana Lozova +31 85 250 0575 [email protected] About ENPICOM ENPICOM is an innovative bioinformatics software engineering company delivering groundbreaking products and customized solutions to decode the immune system and improve human health. With a diverse team of experts in various disciplines, ENPICOM serves customers from all over the world, ranging from academic research centers doing basic research related to the immune system to biotech and global pharmaceutical companies focusing on the discovery and development of novel antibodies and vaccines. Leveraging a unique mix of immunology knowledge, bioinformatics methods, and software development skills, ENPICOM offers a worldclass repertoire sequencing data analysis solution – the ImmunoGenomiX (IGX) Platform. IGX is an innovative platform to manage, analyze, visualize, and interpret immune repertoire sequencing data from T and B cell receptors. Moreover, together with its partners, ENPICOM also delivers full immune repertoire sequencing and analysis on demand. For additional information, please visit enpicom.com Effortless Measurement of All Four NADs and Glutathione for Laboratories n response to the escalating demand from clinicians and researchers for precise and fast NAD measurement, NADMED unveils an innovative technology designed for extracting and measuring all four NADs and two glutathiones. The method is founded on colorimetric quantification, applicable to blood, tissue, or cells. The distinguishing feature of the NADMED method lies in its ability to measure metabolites individually, setting it apart from other methods and delivering exceptional accuracy comparable to mass spectrometry. I Business News

Microbioz India, February 2024 | 35 Based on transparent scientific research from the University of Helsinki, NADMED's technology presents fresh business opportunities for laboratories. NADMED's laboratory technology is available in kits, with the first EU IVDD compliant (CEmarked) kits for blood NAD+ and NADH already for sale. Kits for the remaining metabolites are slated for production by the year's end. Measuring NAD metabolites and glutathione has long been hindered by the absence of a rapid and reliable method, impeding both research and the development of clinical applications for these REDOX molecules. NADMED's technology presents a fast, scalable, and cost-effective solution. Unlike mass spectrometer analysis, which may take days, NADMED analysis yields results within hours. Moreover, NADMED makes this analysis accessible for laboratories without mass spectrometry, at a fraction of the total cost. “We believe that the NADMED method will advance science and medical practice by enabling larger and quicker clinical trials and in due course, diagnostics. NAD measuring should be seen as a first-line diagnostic tool in the future to fight for example degenerative diseases and metabolic disorders.”, says Jari Närhi, CEO of NADMED. About NADMED NADMED is a spin-out company from the University of Helsinki. NADMED offers kits and laboratory services for accurate, quick, and costeffective measurement of NADs from any biological sample. NADs (nicotinamide adenine dinucleotides) are coenzymes that are essential to metabolism, regulating hundreds of biochemical reactions in all our cells. They exist in four different types: NAD+, NADH, NADP+, and NADPH, the ratios of which in different cells and tissues signal for nutrient availability and cellular growth and repair. NADs are necessary for all living creatures, from plants to animal kingdom. Business News

Microbioz India, February 2024 | 36 Orchid Pharma’s Exblifep gets USFDA approval; stock surges The company based in Chennai has received the United States Food and Drug Administration (USFDA) approval rchid Pharma stock surged over 6 per cent on the NSE on Friday, following the receipt of approval for its Enmetazobactam injection, a Beta-Lactamase Inhibitor invented in the country. The company based in Chennai has received the United States Food and Drug Administration (USFDA) approval for its Exblifep, it said in a stock exchange filing and added that the development comes in close succession to the recent recommendation for approval by the European Medicines Agency (EMA). The product is expected to be launched in the US market within a couple of quarters. The New Drug Approval (NDA) allows the use of Exblifep (Cefepime and Enmetazobactam) as an injection for the treatment of patients aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible microorganisms such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex. Manish Dhanuka, Managing Director at Orchid Pharma, said, “While the EMA recommendation for the grant of marketing authorization last month was a big achievement, the USFDA approval reinforces Orchid’s position on the safety of the drug and its innate need in the times of increasing Antimicrobial resistance.” The stock surged by 6.64 per cent to close at ₹1,225 on Friday. Sun Pharma, Cipla, Dr Reddy's, Lupin in race for slice of a $100 billion a year pie Indian pharma companies have started developing their own versions of Novo Nordisk's wildly in demand Wegovy. • • un Pharma, Cipla, Dr Reddy's and Lupin are aiming to grab a slice of the burgeoning weight-loss treatment sales pie, both at home and abroad They have started developing their own versions of Novo Nordisk's wildly in demand Wegovy. With some analysts predicting a weight-loss market reaching $100 billion a year or more by the end of the decade, executives at Indian pharma firms have started work on Wegovy versions. Novo Nordisk, according to Reuters report, has been unable to produce enough Wegovy to meet demand in more than half a dozen countries where it has already launched, amid record global obesity rates and people looking for easier alternatives to diet and exercise. US rival Eli Lilly likewise has been unable to meet demand for its weight-loss drugs Zepbound and Mounjaro. Novo has not provided a clear timeline for introducing Wegovy globally, but told Reuters it aims to launch in India in 2026. The move by Indian drugmakers could go a long way toward improving global access to weight-loss drugs and make them far more affordable, analysts said. O S Pharma News

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Microbioz India, February 2024 | 38 "We expect volume expansion to increase multifold by the time patent expires, which is a few years from now," Systematix analyst Vishal Manchanda said. "They will also be available at a much lower price by generic drugmakers." "There is big potential in India... given the lifestyle choices," Cipla Global CEO Umang Vohra said in post-earnings call in January. India has high obesity rates, especially among women, and has the world's second highest number of people with type 2 diabetes, trailing only China. Around 11% of adults in India will be obese by 2035, according to the World Obesity Federation Atlas. Novo's patents for Wegovy, given as a weekly injection, expire in China in 2026, in Japan and Europe in 2031, and in the U.S. in 2032, according to its annual report. The Danish drugmaker is the sole patent holder of semaglutide, the active ingredient in Wegovy and diabetes treatment Ozempic, which are not yet approved in India. It declined to comment on when its patent would expire in India. Sun Pharma is working on its own experimental drug to treat type 2 diabetes and obesity. Others are taking a more traditional generic drug path. "Dr. Reddy's and Cipla are making a copy of the innovator drug more like a generic version, while Sun is working on its own innovator drug. So, Sun will have to do clinical trials. Its drug will be novel and patented," Manchanda said. Mankind Pharma records block deal of 6.49 million shares round 6.49 million shares or 1.62 percent stake changed hands in 24 block deals on Mankind Pharma on February 8, Bloomberg reported. Buyers and sellers of the deal were not known immediately. Moneycontrol had reported Mankind Pharma promoters Sheetal Arora, Arjun Juneja and Puja Juneja have decided to sell a combined stake of 1.62 percent in the company to comply with the requirements of minimum public shareholding. According to guidelines laid out by market regulator Sebi, all listed firms should maintain a minimum public shareholding of 25 percent. A block deal of around Rs 1,330 crore has been launched for the February 8 divestment at a floor price of Rs 2,050 per share, the Moneycontrol report added. Kotak Mahindra Capital and IIFL Capital acted as advisors on the deal. The Mankind Pharma stock has risen by nearly 20 percent in the last six months. The aggregate promoter and promoter group shareholding as on February 7 stood at is 76.5 percent of the total paid-up equity share capital of the company. After completion of the sale, the aggregate promoter and promoter group shareholding in the company is now reduced to 74.88 percent, as per the regulatory filing. Aurobindo Pharma shares fall 3% as USFDA issues 9 observation to subsidiary urobindo share price slipped more than 3 percent in the opening trade on February 5 after the company paused some of the manufacturing at one of its units after the United States Food and Drug Administration (USFDA) issued nine observations for its subsidiary. At 9.23 am, Aurobindo Pharma was quoting at Rs 1,030.55, down Rs 35.80, or 3.36 percent, on the BSE. The USFDA inspected Unit-III, a formulation manufacturing facility of Eugia Pharma Specialties, a wholly owned subsidiary of Aurobindo Pharma, in Telangana’s Sangareddy district from January 22 to February 2. A A Pharma News

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Microbioz India, February 2024 | 40 The company has decided to temporarily stop manufacturing on certain lines to conduct holistic investigation and corresponding partial distribution thereto. At this point in time, company sees no material impact on the business, it told exchanges. Eugia US Manufacturing LLC, USA, a wholly owned step-down subsidiary of Aurobindo Pharma, has entered into an asset purchase agreement with Empower Clinic Services New Jersey, LLC to dispose of its business assets as a going concern with related assets and liabilities and employees. A sum of $52 million will be received in cash from the disposal plus $ 58 million in lease payments made to Eugia US Manufacturing LLC and/or its affiliates, over the 20 years lease term including extensions. The transaction is expected to close within 90 days from the date of definitive agreement, subject to fulfilment of closing conditions referenced in the definitive agreement including financial closure by the buyer, the company said. The company's board will meet on February 10 to consider and approve the unaudited standalone and consolidated financial results for the December quarter and nine-month period ended on December 31, 2023. Cipla partners with CSIRCDRI to advance Ophthalmic Antifungal Treatment Development ipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) announced today that the company has entered into a collaborative research agreement with CSIR-Central Drug Research Institute (CSIR-CDRI), a constituent laboratory of the Council of Scientific and Industrial Research, Government of India, to jointly develop a novel ophthalmic formulation for fungal keratitis. The collaboration aims to leverage the combined expertise and resources of both organizations to develop a safe and efficacious drug for fungal keratitis. Globally, approximately 1.2 million cases of fungal keratitis are reported every year with tropical countries recording a higher incidence. Fungal keratitis often occurs following ocular trauma and exposure to fungal pathogens from organic matter, thus putting agricultural workers at greater risk. Other risk factors include the use of local steroid eye drops, injury, poor personal hygiene, and regular contact lens wear. Left untreated, the condition can result in corneal destruction, leading to a profound loss of vision. Existing therapies have limitations, such as the need for prolonged and frequent use of drugs, and emerging drug resistance. CSIR-CDRI has developed a prototype formulation for an antifungal drug to optimize its delivery in the eye. In preclinical studies, this formulation supports faster resolution of the infection. Cipla will scale up the product, conduct the required studies and seek regulatory approvals for commercialization, ensuring accessibility for those in need. Commenting on this association Mr. Umang Vohra, Managing Director, and Global CEO, Cipla, said, “At Cipla, our growth is centered on our commitment to patients, extending care to communities through patientcentric innovation. This collaboration with CSIRCDRI is a testament to our commitment to providing innovative and top-quality healthcare solutions to all those in need, encompassing drugs, devices, and diagnostics. With this, we are sustaining our antimicrobial resistance stewardship by investing in anti-infectives and leading industry voice in the fight against AMR.” C Pharma News

Microbioz India, February 2024 | 41 Welcoming this partnership, Dr Radha Rangarajan, Director CSIR-CDRI said, “Our research focuses on finding innovative, costeffective solutions for India’s unmet clinical needs. CDRI scientists have developed a unique ophthalmic formulation of the antifungal drug. This in turn, is expected to accelerate cure and lead to better outcomes. Our collaboration with Cipla will enable the translation of the research into a drug product, with the potential to reduce the burden of disease.” This research and development endeavor unite both Cipla and CSIR-CDRI in their commitment to affordable healthcare. The two partners have an ongoing collaboration for the development of Levormeloxifene for contraception. Pharma News

Microbioz India, February 2024 | 42 CBD vs. THC: Understanding the Key Differences annabidiol, known as CBD, and tetrahydrocannabinol, abbreviated THC, are some of the most known cannabinoids in cannabis. They have similarities but also have different legal definitions, consequences and potential uses in medicine. Chemical Structure: THC Vs CBD THC and CBD are both types of cannabinoids that can be found in the marijuana plant. THC is a psychoactive component which alters your mood hence causing a feeling of “high”. CBD has no any psychoactive impact therefore it does not produce high effects at all. Psychoactive Effects: CB1 receptors in the brain bind to THC like the endocannabinoids thereby causing their psychoactivity and highness feeling when used. On the other hand, CBD is associated with low affinity for CB1 receptors hence no psychoactivity. Medical Uses: CBD vs THC Other therapeutic applications of THC include analgesic efficacy, antiemetic properties, appetite enhancer activity, muscle relaxant capabilities and it could be administered to chemotherapy patients suffering from vomiting among others. It is commonly used for various conditions such as chronic pain, multiple sclerosis and chemotherapyinduced vomiting in medical marijuana. CBD has gained attention due to its potential benefits such as anxiolytic action against anxiety disorders; reduction in pain measured by analgesiometry; suppression of inflammation via inhibition prostaglandin E(2) synthesis; facilitation of sleep via sedation; while maybe treating epilepsy. Oils, capsules or topical forms can be used. C Guest Post

Microbioz India, February 2024 | 43 Legality: This is because THC makes people high hence outlawed by many countries across the globe due to this illicit nature at times attracting abuse charges. But there are places where THC is legal for either medical uses or recreational uses based on prevailing regulations. However according to certain rules CBD derived from hemp plants with less than 0.3% THC content is legal mostly in United States. However, CBD derived from marijuana containing more than 0.3% THC content may have different legal restrictions or even be illegal in some jurisdictions. Side Effects: THC can sometimes impair memory, coordination and judgement, causes dry mouth, reddening of the eyes, raises heart rate as well as induce anxiety or paranoia especially when taken in large doses. While rare, CBD has been reported to cause a few side effects including dizziness. Some people may experience sleepiness and diarrhea. Interactions: It’s important for patients considering using any THC or CBD product to speak with their physician first about potential drug interactions because both substances may affect how other medications are metabolized in the body. Towards the end of this article it will be made clear that while THC and CBD belong to the cannabinoids family found in cannabis plants; they stand apart from each other due to such differences related to their psychotropic effects; medicinal applications such as pain relief and inflammation reduction; legalization issues as well as possible adverse reactions. With its nonpsychoactive profile, CBD might offer substantial health benefits without leading to a high sensation which makes it very appealing to people who seek relief without getting intoxicated by THC. Guest Post

Microbioz India, February 2024 | 44 Certification for Liquid Flowmeters ESTA Analytical offers a choice of certification services to demonstrate the reliability and quality of each Liquid Chromatography flowmeter or microflowmeter it delivers to a customer lab. Caption: Conformity or Calibration – which certification tech note All flowmeters come with a free Certificate of Conformity demonstrating compliance of each individual device with the company’s published performance specifications. This certification is typically sufficient for any application involving constant monitoring of flow rate. For labs looking to validate or certify the performance of a pump within its range of operation this requires the use of flowmeters which are themselves validated. For this TESTA Analytical offers a traceable calibration service for its range of flowmeters. Traceable to known reference or standard, each Certificate of Calibration certifies that a 10-point calibration protocol has been undertaken covering the full range of operation for a supplied flowmeter. In regulated labs, traceable calibrations often require re-validation on an annual basis. Traceable calibration provides increased confidence in your obtained results and therefore in any validation based upon these results. Both certificates play vital roles in quality assurance and are essential for maintaining consistent and reliable flow rate measurement. For further information please visit https://testaanalytical.com/app-chromatography.html to download the ‘Conformity or Calibration - which certification do you require for your Flowmeter?’ technical note 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 end user and 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]) T Product Showcase

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Microbioz India, February 2024 | 46 Lauda presents the First Mobile Battery-Powered Ultra-Low Temperature Chest Freezer Story source/Credit: LAUDA he constant temperature equipment manufacturer LAUDA is launching a new product on the market to start the new year: the Mobifreeze M 270, the first mobile batterypowered ultra low-temperature chest freezer. Valuable samples or APIs can be safely stored and transported from -86 °C to -50 °C with high temperature resistance – without dry ice. Natural refrigerants are used to provide active temperature control instead. Safe storage AND transport of valuable samples The actively temperature-controlled, mobile ultralow-temperature chest freezer with sophisticated insulation technology has a battery life of four hours and therefore enables the cold chain to be reliably maintained in intralogistics and for interfactory transport in road logistics. Delicate and temperature-sensitive substances such as gene therapy medicinal products, monoclonal antibodies or vaccines, which require storage under validated conditions, can now be transported under identical conditions. Cooling is freely adjustable between -86 °C and -50 °C. If the set limits are exceeded, a warning is provided by an acoustic and visual signal. An integrated data logger stores the temperature and alarm data. In addition to this, a customerspecific monitoring system can be installed. The Good Distribution Practice (GDP) Guidelines for pharmaceutical products can therefore be complied with to the full extent. Furthermore, the Mobifreeze can be used as a hybrid system with flexible switching between battery and mains operation, stationary use for storage, or mobile use for transport. Transfer processes that pose a risk of damage and contamination to the samples are avoided, which means that the overall logistics are more product-friendly. Safe, comfortable handling, cost savings, and environmentally friendly operation Battery operation also means that dry ice, which is a hazardous material, and phase-change materials (PCM for short) can be dispensed with during transport. In particular, dispensing with the former eliminates significant health risks for employees. At the same time, expensive exhaust air systems and specific personal protective equipment are no longer required. Together with the elimination of the PCMs and dry ice as a consumable, this represents a significant cost saving. Natural, futureproof refrigerants are used in the refrigeration unit of the Mobifreeze. The ultra-low temperature chest freezer therefore eliminates health risks, offers flexibility, and cuts operating costs. The freezer is operated via a 4.3" touch screen, whose functionality is also not restricted by gloves. Password-protected user management prevents unauthorized access to configuration parameters. The mobile ultra-low temperature chest freezer is equipped with two rotating heavy-duty casters, which make movement and steering easy in spite of the volume of 270 l. The ergonomic handles provide a secure grip and the dead man's brake offers extra safety. In addition to this, the bottom panel and wheels are safeguarded by ram and impact protection. The stable design enables it to be loaded with a forklift truck. T Product Launches

Microbioz India, February 2024 | 47 This transport innovation for the biopharmaceutical industry is now available. LAUDA, the temperature control specialist, demonstrates once again that it acts upon its claim “Empowering Excellence. For a better Future” and re-thinks established methods. About LAUDA We are LAUDA – the world leader in precise temperature control. Our constant temperature equipment and systems are at the heart of important applications, contributing to a better future. As a complete one-stop supplier, we guarantee the optimum temperature in research, production and quality control. We are the reliable partner for electromobility, hydrogen, chemicals, pharmaceuticals/biotech, semiconductors and medical technology. We have been inspiring our customers for almost 70 years with our expert mentoring and innovative solutions – every day anew and all over the world. In our company, we always go one step further. We support our employees’ development and are constantly developing ourselves: to create a better future together. INTEGRA's innovative modules simplify magnetic bead purification workflows Story source/Credit: INTEGRA Biosciences AG INTEGRA Biosciences is excited to announce the launch of its MAG and HEATMAG modules for efficient, automated magnetic bead purification. hese innovative solutions allow researchers to streamline several processing steps in molecular biology and proteomics workflows for maximum lab throughput. These time-saving devices are complemented by the COLDPLATE and BIOSHAKE – for precise temperature control and orbital shaking of magnetic beads, respectively – to further streamline protocols. The MAG and HEATMAG modules are designed to revolutionize the speed and simplicity of magnetic bead purification. They boast exceptionally powerful magnets that automatically move up and down for fast and precise magnetic bead collection, removing the need to manually move plates and tubes to and from the magnet. The magnet height is also adjustable to match the volume requirements, and the modules are fully compatible with various labware formats to offer versatility like never before. The HEATMAG provides all of these capabilities with the addition of a unique heating element for superior temperature transmission, making it the ideal solution for lysis and elution workflows. Both MAG and HEATMAG can be used as standalone devices, or paired with INTEGRA’s ASSIST PLUS pipetting robot to offer seamless, walk-away magnetic bead purification with total confidence. Alternatively, combine the modules with the MINI 96, VIAFLO 96 or VIAFLO 384 pipetting platforms to process whole plates or multiple tubes simultaneously. COLDPLATE and BIOSHAKE modules offer automated thermal and shaking control for greater reproducibility. The systems can be combined with the ASSIST PLUS, VIAFLO 96 and VIAFLO 384 platforms for high throughput workflows, or used as standalone plug-and-play modules. “These top-of-the-range modules are incredibly exciting additions to our offerings for molecular biology and proteomics labs,” said Jan-Peter Baldin, Project Manager at INTEGRA Biosciences. “They make it easier than ever to achieve high quality magnetic bead purification, heating, cooling and shaking with minimal hands-on time, streamlining workflows and boosting productivity.” Visit the INTEGRA Biosciences website to learn more T Product Launches

Microbioz India, February 2024 | 48 EVIDENT Launches Fifth Annual Image of the Year Contest with New Video Category Story source/Credit: Evident Evident, formerly a wholly owned subsidiary of Olympus Corporation, announced its fifth annual Image of the Year competition is now open for entries through April 30, 2024. Each year, the contest recognizes the best in scientific imaging worldwide. or the first time, the 2024 contest will welcome video submissions to show the art of capturing small changes in motion under the microscope. Contestants may enter by uploading up to three images and three video files, with a description of the equipment used, at Olympus-LifeScience.com/IOTY. Winners will be selected by a jury and announced in fall 2024. Contest Details The global prize and three regional prizes will be awarded to the scientific images that receive the highest scores. The grand prize for the global winner is an Olympus SZX7 stereo microscope with a DP23 digital camera or X Line™ objectives. Prizes also include an Olympus CX23 upright microscope or SZ61 stereo microscope for the global winner of a new dedicated category for video and for the regional winners in Asia, Europe and the Americas. An additional prize of an SZ61 stereo microscope will be awarded to the winner of a dedicated category for materials science and engineering images. The international jury consists of experts in science and imaging. Returning from last year are Geoff Williams, manager of the Leduc BioImaging Facility at Brown University; Harini Sreenivasappa, microscopy facility manager of the Cell Imaging Center at Drexel University; and Rachid Rezgui, research instrumentation scientist at New York University Abu Dhabi. New to the jury are Professor Wen-Tai Chiu, Department of Biomedical Engineering at National Cheng Kung University; Nicolas Schilling, microscopy application specialist at the Center for Microscopy and Image Analysis, University of Zurich; and Songhai Shi, professor and doctoral supervisor at the School of Life Sciences, Tsinghua University. All entries will be evaluated based on artistic and visual aspects, scientific impact and microscope proficiency. About the Image of the Year Award Evident’s Image of the Year Award began in 2017 as the Image of the Year European Life Science Light Microscopy Award with the aim to celebrate both the artistic and scientific value of microscopy images. Today, the competition stays true to this mission by encouraging people around the world to look at scientific images in a new way, appreciate their beauty, and share images with others. To learn more about our past award-winning images and the microscope techniques used to captur them, visit Olympus-LifeScience.com/IOTY. F Product Launches

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Microbioz India, February 2024 | 50 About EVIDENT In 2022, Olympus Corporation spun off its Scientific Solutions Division, including its life science and industrial solutions businesses, to establish a new company called Evident. Although our name is different, our expertise, manufacturing capabilities and commitment to our customers, which defined us over the past 100 years, remain unchanged. At Evident, we are guided by the scientific spirit—innovation and exploration are at the heart of what we do. Committed to making people’s lives healthier, safer and more fulfilling, we support our customers with solutions that solve their challenges and advance their work; whether it’s researching medical breakthroughs, inspecting infrastructure, or exposing hidden toxins in consumer products. Evident’s industrial solutions range from microscopes and videoscopes to nondestructive testing equipment and X-ray analyzers for maintenance, manufacturing and environmental applications. Backed by state-of-the-art technologies, Evident products are widely used for quality control, inspection and measurement. In life science, Evident empowers scientists and researchers through collaboration and cutting-edge solutions. We’re dedicated to meeting the challenges and supporting the evolving needs of our customers, continuing to advance a comprehensive range of microscopes for pathology, hematology, IVF and other clinical applications as well as for research and education. Cloud hosted LIMS - 10 Things to Know Before You Jump Story source/Credit: Autoscribe Informatics Autoscribe Informatics (A Xybion Company) took the opportunity in a recent webinar to discuss the much-misunderstood subject of cloud hosted laboratory software solutions. aboratory Information Management Systems (LIMS) are the heart of any modern laboratory, recording and storing all sample and associated meta data, as well as inventory, quality, staff training, and instrumentation information in one place. The choice of whether to keep the application and its associated data local to the laboratory and onpremise, or remotely in the cloud, is a more complex choice than it may seem. Considerations should go well beyond the resource needed to maintain the software and data and the costs of doing so, but often do not. L Product Launches