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The field of drug analysis encompasses various components, such as the identification of new medications, evaluation of their binding affinity and selectivity, characterization of their molecular structures, and assessment of their efficacy through in vitro and in vivo experiments.
The Science of Drug Analysis: All you need to know is this month's cover story, contributed by Microbioz India editorial.

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Published by Kumar Jeetendra, 2023-09-09 00:41:21

Microbioz India, August 2023 Lab edition

The field of drug analysis encompasses various components, such as the identification of new medications, evaluation of their binding affinity and selectivity, characterization of their molecular structures, and assessment of their efficacy through in vitro and in vivo experiments.
The Science of Drug Analysis: All you need to know is this month's cover story, contributed by Microbioz India editorial.

Microbioz India, August 2023 | 51 Looking for a versatile XYZ platform Story source/Credit: Prior Scientific Instruments Ltd. The MOST Versatile XYZ Platform for 2P/3P/Multiphoton/Confocal/Ephys Microscopy Systems he new H189 XYZ High Precision Motorized XYZ Deck is purposely designed to match the increased size and versatility of the latest generation of 2P/3P/Multiphoton/Confocal microscopy systems utilizing all the potential of the added sample space and microscope power of these new microscopes. Important features of the XYZ Deck include: 1. Large removable metric breadboard is ideal for remote sample prep 2. Sample height adjustable from 79.5mm to 410mm 3. 50mm of motorized XY and Z travel 4. Compatible with Queensgate Piezo Z models 5. Ideal for a range of samples from whole animal invivo studies to slides & petri dishes 6. 100 kg XY stage capacity, 25kg Z axis lifting capacity 7. Fast up/down control at the touch of a button 8. Ideal for use with manipulators, probes or other sensory devices 9. Includes deck plate compatible with standard 160mm x 110mm Prior sample holders 10. Compatible with most imaging software via the Prior ProScan III controller Agilent Inaugurates First Integrated Biology Center at Monash University in Malaysia Story source/Credit: Agilent Technologies New facility builds local research capabilities and provides scientists with greater outcomes in support of their research across Malaysia gilent Technologies Inc. has announced the opening of a new full-scale Integrated Biology Center located at Monash University in Malaysia, focused on building local capabilities to accelerate research and development (R&D) in the field of science. The inauguration was held in conjunction with the company’s AcademiaIndustrial Day 2023, hosting distinguished guests from the research community. Housed at the university’s Jeffrey Cheah School of Medicine and Health Sciences at Sunway, the facility is equipped with Agilent’s complete workflow solutions, including high-performing liquid chromatography and mass spectrometry (LC/MS) and gas chromatography (GC/MS) systems, to provide analytical expertise in applied biology research for publications and potential clinical usage. This new facility is the third center of excellence (CoE) established through a long-term partnership with Monash University, including a genomic research lab in 2011, and a proteomics and metabolomics platform in 2016. T A Product Launches


Microbioz India, August 2023 | 52 "The Integrated Biology Center stands as a testament to the university's commitment to research excellence and its strategic plan, Impact 2030. Through Impact 2030, the university strives to be at the forefront of research and actively address global challenges, such as climate change and the creation and sustenance of thriving communities. With Agilent's cutting-edge technologies and expertise, this center will accelerate breakthroughs in applied biology research and its potential clinical applications. We look forward to fostering industry collaborations and making significant contributions to the scientific community in Malaysia and beyond," stated Professor Dato' Dr Adeeba Kamarulzaman, President and Pro Vice-Chancellor of Monash University Malaysia. Chai Meng Fee, Agilent Malaysia General Manager, commented, “Growing scientific knowledge advancement and support is a top priority for Agilent Malaysia. The addition of the Integrated Biology Center strengthens our expanding presence locally and provides scientists with greater outcomes in support of their research work across Malaysia.” In addition to Agilent’s competency training for the center’s lab professionals, this collaboration will provide the opportunity for Agilent and Monash University to explore potential partnerships with start-ups, academia, and other laboratories in Malaysia. Today, Agilent has a 200,000 sq ft facility manufacturing key products for the company’s spectroscopy line, diagnostics and genomics, and vacuum pump division in Penang, as well as a sales office located at Petaling Jaya in Selangor, Malaysia. About Agilent Technologies Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.85 billion in fiscal 2022 and employs 18,000 people worldwide. New Application Note - Streamlined Purification of Assay-Ready Oligonucleotides by Automated HPLC Story source/Credit: Gilson UK Gilson Applications Note AN1008 ligonucleotides must be of high purity when used within molecular biology applications such as qPCR, nextgeneration sequencing, and microarray analysis Custom manufactured oligonucleotides require additional purification steps after synthesis to separate the full-length products from contaminants such as truncated sequences, base protecting groups, and other impurities. Efficient purification of oligonucleotides, of different lengths and at different production scales, presents a manufacturing challenge. The GX-271 Oligo Purification System, configured with automated preparative and analytical HPLC capabilities, can be used to isolate, analyze, and desalt reagent-grade oligonucleotides in one continuous run. On-board fraction analysis during runs enables on-the-fly sample addition resulting in no downtime on the instrument. Built-in error handling conditions at various stages of the process prevent sample loss and assure full walk-away capabilities.In this application note, Gilson explore how the VERITY® Oligo Purification System, configured with automated preparative and analytical HPLC capabilities, can be a solution to isolate, analyze, and desalt reagent-grade oligonucleotides in one continuous run. O Product Launches


Microbioz India, August 2023 | 53 Gyros Protein Technologies introduces PurePep EasyClean Auto Kit for automated parallel peptide purification Story source/Credit: Gyros Protein Technologies New automated kit overcomes major bottleneck in peptide production, providing optimized simultaneous workflows yros Protein Technologies AB, a leading provider of peptide synthesizers and reagents, and a pioneer in automated nanoliter-scale immunoassays, has announced the launch of its PurePep® EasyClean (PEC) Auto Kit for the automated parallel purification of peptides, accelerating downstream processes for research, development, and production of simple to complex peptide drugs and therapies. Based on Gyros Protein Technologies’ orthogonal PurePep EasyClean technology, the PEC Auto Kit utilizes a simple catch-and-release methodology for purification of chemically synthesized peptides. The new Auto Kit allows users of the PurePep Chorus and Symphony®X synthesizer to perform peptide synthesis and purification on a single instrument, further increasing process efficiency. Conventional chromatography, including reversedphase liquid chromatography (RP-HPLC) is a major bottleneck in peptide production, both in academia and industry, due to its limited capacity in higher throughput purifications, and the significant volumes of toxic solvents required. In addition, operation of RP-HPLC is labour intensive and requires specialist skills. Gyros Protein Technologies’ PEC Auto Kit requires up to 90% less hands-on time per peptide (6 minutes vs ~ 1 hour) and 90% less solvent consumption, facilitating parallel purification of 6 or more purified peptides in under 6 hours. Mark Vossenaar, General Manager, Biopharmaceutical Development Division, Gyros Protein Technologies, commented: “The PEC Auto Kit is the first automated solution for parallel peptide purification to remove a major bottleneck in the downstream production process, saving time and resources for this otherwise rate-limiting and labor-intensive step. The first newly developed product in the PurePep family following acquisition of the PEC technology in 2022, the introduction of the PEC Auto Kit further reflects our commitment to providing reliable and efficient solutions for the purification of high-quality peptides for research and production.” G Product Launches


Microbioz India, August 2023 | 54 Adrian Glas, CEO, Peptides Speciality Laboratories, said: “As a customer, the PurePep EasyClean technology has been an established method for purification in our labs from the very beginning. The introduction of the PEC Auto kit is the missing piece to a fully automated peptide manufacturing process. Now allowing for parallel post-synthesis purification, the new platform was easily integrated into our laboratory methods and has provided immediate benefits. The automation has taken it to the next level in terms of time efficiency and resource reduction!” About Gyros Protein Technologies Gyros Protein Technologies enables bioanalytical solutions and peptide synthesis, helping scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high performance nanoliter-scale immunoassay platforms, Gyrolab® xPand, and Gyrolab xPlore™, and Gyrolab immunoassay kits are used by scientists at leading pharmaceutical, biotech, CRO, and CMO companies in the development and manufacturing of various biotherapies including those based on peptides, antibodies, cell and gene therapies and vaccines. Gyrolab immunoassays provide key workflow advantages of speed, automation, and low reagent usage, and assay quality advantages of wide dynamic range with robust precision and reproducibility in applications including pharmacokinetics/pharmacodynamics, immunogenicity, and analysis of bioprocess-related impurities. Our low to mid-scale peptide synthesizer platforms, PurePep® Chorus, Symphony® X, and PurePep® Sonata+, and chemistries deliver uncompromising purity, flexibility, and quality synthesis for discovery and pre-clinical studies of simple to complex multifunctional peptides. Our peptide synthesis and bioanalytical solutions accelerate the discovery, development, and manufacturing of safer biotherapeutics. Gyros Protein Technologies is part of the Biopharmaceutical Development Division of Mesa Laboratories, Inc. (Nasdaq: MLAB). PacBio Begins Commercialization of the Onso Short-Read Sequencing System Story source/Credit: PacBio The Onso Platform Delivers Extraordinary Accuracy Which Creates New Possibilities for Research and Translational Sequencing Application acBio a leading developer of high-quality, highly accurate sequencing solutions, announced that customer shipments of Onso short-read sequencing instruments will commence today. As previously announced, the Onso system is designed to provide extraordinary accuracy through its novel sequencing by binding (SBB) chemistry in a user-friendly and flexible benchtop platform. "When we announced the Onso platform last year, I knew it would be a game changer for genomics," said Christian Henry, President and Chief Executive Officer of PacBio. "We believe PacBio is the only company to offer both highly accurate, native short and native long-read sequencing technologies. As a result, we believe this uniquely positions us to offer more complete solutions to our customers’ challenges and help researchers unlock novel insights in oncology and disease research, among other areas. P Product Launches


Microbioz India, August 2023 | 55 I want to thank the Broad Institute of MIT and Harvard, Corteva Agriscience, and Weill Cornell Medicine for their invaluable feedback, helping us to improve this cutting-edge system and bring it to market." "Over the last several months, we have tested out the Onso system in order to understand how highquality sequence data can be used in the context of germline and somatic applications. We already have some novel findings and are excited to see where the platform goes from here," said Niall Lennon, Senior Director of Translational Genomics at Broad Institute of MIT and Harvard. With Onso’s potential to achieve Q40+ levels of accuracy (one error in 10,000 bases), we believe scientists will have the opportunity to gain more insight into ctDNA research applications like minimal residual disease (MRD) monitoring and other "needle-in-haystack" applications which require highly sensitive variant detection. This may ultimately allow researchers to detect rare variants missed by other short-read technologies. "Since we started testing the Onso system across a range of different applications, my laboratory at Weill Cornell Medicine is seeing impressive data quality well above the industry norm of Q30," said Dr. Chris Mason. "We’ve had several runs with raw quality scores in excess of Q50, which I have not seen using alternative technologies. We see Onso’s capabilities opening up new possibilities for research and translational applications where accuracy is a critical need for success." In addition, we believe this level of accuracy can add value to common mid-throughput sequencer applications such as exome sequencing, single-cell RNA sequencing, and targeted panels to support inherited disease and oncology research. PacBio plans to launch library preparation solutions to support a wide range of sample types, and library conversion kits to allow existing third-party libraries to be sequenced on the Onso system. The Onso system is designed to deliver 400 to 500 million reads during a 48-hour sequencing cycle (for 2×150 paired-end reads). PacBio plans to offer 200 and 300-cycle kit configurations enabling pairedand single-end reads. The system list price in the U.S. is $259,000. Onso systems will begin shipping to customers across the globe, reflecting the global service and support capabilities of PacBio’s commercial organization. The Translational Genomics Research Institute (TGen), part of City of Hope, is one of the first customers to receive an Onso system. "We are excited to bring the Onso instrument inhouse to TGen. Our early access data demonstrates the ability to accurately detect ultra-low variants without the need for high-complexity error correction across a broad spectrum of applications, including infectious disease and liquid biopsy research. We believe SBB technology will positively impact our research/clinical mission to enable early detection, monitor treatment response, and track resistant mutations," said Stephanie Pond, Vice President of Emerging Opportunities at TGen. "With our first shipment of Onso today, we have launched our second major platform this year. I am extremely proud of the entire PacBio team for this remarkable achievement," said Mark Van Oene, Chief Operating Officer at PacBio. "Revio, our new flagship long-read sequencer and now Onso, demonstrate our commitment to providing genomics researchers with powerful tools that have the potential to revolutionize the genomics industry." PacBio expects to complete the installation of the first Onso instrument and ship related consumables later this month. The milestone payment associated with PacBio’s acquisition of Omniome will be triggered once both the Onso instrument and related consumables have been shipped. DNA-Encoded Libraries (DELs) and NanoBRET™ Target Engagement Assays Accelerate Drug Discovery Story source/Credit: Promega UK Ltd New study by Promega and WuXi AppTec demonstrates novel chemical probes from DELs new study demonstrates how the combination of DNA-encoded libraries (DELs) and NanoBRET Target Engagement technology can accelerate early-stage drug discovery. Reported in Cell Chemical Biology, researchers from Promega Corporation and WuXi AppTec generated new chemical probes from molecules identified through a DEL screen. This research opens new opportunities to develop novel NanoBRET Target Engagement Assays aimed at many understudied classes of proteins, rapidly accelerating “hit to lead” efforts in identifying new potential therapeutics. A Product Launches


Microbioz India, August 2023 | 56 Generating Novel Chemical Probes from DELs DELs are increasingly popular tools used to rapidly screen billions of molecules for early-stage drug discovery. Each molecule is tagged with a short DNA “barcode” that can be used to identify those that successfully bind to a given target. In the Cell Chemical Biology paper, scientists from Promega and WuXi AppTec aimed to develop new chemical probes using molecules selected from these massive pools. These probes would be used in a NanoBRET Target Engagement Assay, a tool for studying the interaction between a chemical compound and its target protein in live cells. The authors screened 16.8 billion compounds from WuXi AppTec’s 41 established DELs against aurora kinase A, a protein implicated in the invasive growth of certain cancers. They identified two representative “hits” that bound to the target and developed a method to replace the DNA barcode of each “hit” with a fluorophore. The fluorophore is responsible for the light signal generated in a NanoBRET assay in live human cells. The team found that this new probe could be used effectively to characterize novel inhibitors targeting aurora kinase A, providing critical engagement characteristics such as affinity, selectivity and cellular permeability. “It was very clever of the authors to appreciate that the DEL read-out not only identified a chemical binder for a protein, but also a place to attach a tracer,” says Aled Edwards, Chief Executive of the Structural Genomics Consortium, a public-private partnership that develops open-access chemical probes to support drug discovery and development. “One can only imagine what could be if there were DEL hits for all human proteins.” Accelerating Drug Discovery The authors demonstrate that DELs can benefit chemical biologists who require verification of live cell target engagement for their protein of interest. This is particularly beneficial for understudied protein classes that may not have existing chemical probes. Additionally, they note that the NanoBRET assays help drug discovery researchers accelerate their workflow by providing data used to identify the most promising leads. They conclude, “Our findings support that DELderived BRET probes facilitate prioritisation of not only the chemical matter identified from the DEL but may also serve as general live-cell screening tools for surveying broader chemotypic diversity at the target of interest.” Read the open access paper, “DELs enable the development of BRET probes for target engagement studies in cells” About Promega Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products support a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. For over 40 years these tools and technologies have grown in their application and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Product Launches


Microbioz India, August 2023 | 57 Waters Launches XBridge Premier GTx BEH SEC Columns for Gene Therapy Applications Story source/Credit: Waters Corporation he new Waters™ XBridge™ Premier GTx BEH™ SEC columns are aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. They are ideal for process development, formulation studies, regulatory filing support, along with ongoing process monitoring as well as quality control. Waters' new chromatography columns are aimed at improving the analysis while lowering the cost of gene therapies Reduces the cost of gene therapies by using 3-10x less sample than other methodsi while generating faster results and more drug substance information. XBridge Premier GTx BEH SEC columns and a new multi-attribute quantification method doubles analytical speed, quadruples sensitivity, and increases resolution of target analytes by up to 50%.ii The combination of size exclusion chromatography (SEC) and Wyatt Multi-Angle Light Scattering (MALS) generates key quality and process attributes in characterizing adeno-associated viral (AAVs) vectored gene therapies. Waters Corporation introduced the first in a new line of size exclusion chromatography (SEC) columns aimed at improving the analysis while lowering the cost of gene therapies, specifically adeno-associated viral (AAV) vectors. The new Waters™ XBridge™ Premier GTx BEH™ SEC columns doubles the speed of measuring the potency and safety of AAVs. Combining the columns with light scattering technologies from its Wyatt Technology portfolio deepens the level of information acquired from a single experiment and optimizes the manufacturing of these novel gene delivery vehicles. "We are witnessing a revolution in medicine thanks to gene therapies like AAVs," said Erin Chambers, Vice President, Consumables and Lab Automation, Waters Corporation. "A small quantity of a gene therapy, such as one of the best-selling eye treatments, can retail for more than $400,000 per eyeiii. This makes it imperative that process and formulation development tests measure multiple attributes of the drug at once while consuming as little of it as possible. It's why Waters' low adsorption, high-efficiency XBridge Premier GTx BEH SEC columns are such a good choice for process development, formulation studies, regulatory filing support, along with ongoing process monitoring as well as quality control." Avid Bioservices (Tustin, California) received early access to the XBridge Premier GTx columns. "The XBridge Premier GTx BEH SEC columns significantly widened the dynamic range of our SEC platform method for AAV aggregate analysis," says Kilian Witzel, Senior Scientist, Analytical Development Viral Vectors, Avid Bioservices, Inc. "It is now possible to analyze AAV aggregates from small amounts of sample with an HPLC method that is up to five times faster than conventional SEC methods for this application. This will help us expedite study timelines and reduce overall costs." AAVs are modified viruses made in bioreactors by living cells and are the number one vehicle for carrying therapeutic genes into human cells. Waters scientists have developed a fast and efficient multiattribute quantification methodiv of characterizing AAVs that features the following Waters products: 1. ACQUITY™ Premier UPLC™ Systems or Arc™ Premier HPLC Systems 2. XBridge Premier GTx BEH SEC 450Å 2.5 μm columns T Product Launches


Microbioz India, August 2023 | 58 3. Arc Premier 2489 UV/Visible detector or 2998 photodiode array detector 4. Wyatt™ DAWN™ multi-angle light scattering detector 5. Wyatt Optilab™ differential refractive index detector 6. XBridge Premier GTx BEH SEC columns are now available worldwide from Waters. Additional Resources Learn more about Waters Gene Therapeutics Columns Download the app note Improved Size-Exclusion Chromatography of AAVs with XBridge Premier GTx BEH SEC 450Å SEC 2.5 µm Columns References [i] According to beta customer AAV sample analysis and the optimization of lower volume 2.5 µm particle SEC column technology that can produce >3x more concentrated peaks versus an industry standard 7.8 x 300 5 µm particle SEC column. [ii] As compared to industry-standard, UV-based HPLC methods employing 5 µm silica particles in stainless steel columns limited to measuring aggregation and titer. [iii] Life Sciences Intelligence, May 24, 2023: “The Top 5 Most Expensive FDA-approved Gene Therapies” [iv] Method captures the following AAV information: aggregate vs. monomer content, titer, encapsidation ratio, nucleic acid vs. monomer ratio, concentration, absolute molar mass and size, and radii. About Waters Corporation Waters Corporation (NYSE: WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 14 manufacturing facilities, and with products available in more than 100 countries. Waters, XBridge, BEH, Wyatt, DAWN, Optilab, Arc, UPLC, and ACQUITY are trademarks of Waters Corporation. Titian Software enters a 3- year agreement with leading life science company Story source/Credit: Titian Software Ltd Mosaic software agreement enables easy extension of Evotec’s systems and supports further growth itian Software LTD, the global leader in life sciences sample management software, and the life science company Evotec have signed a 3-year agreement to expand their collaboration around Titian Software’s Mosaic Sample Management Platform. Mosaic forms part of Evotec’s plans to expand and harmonise sample management throughout the organisation, underpinning its expanding services. The new agreement provides unlimited Mosaic software user licenses to enable rapid deployment across new Evotec sites, plus streamlines access to Titian service teams, which Evotec can draw on according to business needs. In return, it allows Titian to plan and recruit for these service demands and respond agilely. Olivier Casamitjana, Senior Vice President and Global Compound Management Head at Evotec said: “This agreement aligns Titian as a solution provider with our plans to expand our business further, enabling easy extension of Evotec’s systems and ensuring Titian can respond dynamically to our operational needs.” Evotec has relied on Mosaic software for sample management and tracking for nearly 20 years. T Product Launches


Microbioz India, August 2023 | 59 This is not the first collaboration between Evotec and Titian; projects include the co-development of ground-breaking technologies such as acoustic dispensing workflows, and recently on interorganisational synchronisation of inventory so that Evotec can share live inventory data and live shipment updates securely with each customer. This latter capability is included in the latest release of Mosaic software, version 9.0. Nicholas Spurrett, CEO at Titian Software, commented, “This is a significant investment by Evotec, which is a vote of confidence in the Mosaic software platform and in Titian being a trusted partner and foundation for Evotec to build on. The new agreement - offering unlimited licenses, prepurchase service days for ‘support on tap,’ and new technologies underpinning our services - provides a flexible way of working to suit the evolving needs of drug discovery.” About Evotec SE Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 4,900 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. About Titian Software Titian Software is the industry leader in providing sample management software for life science applications. Trusted by pharma, biotech, and CRO institutions worldwide, Titian offers software products and consultancy services that improve the supply of samples - small molecules, reagents, DNA, proteins, antibodies, cell lines, blood, serum, tissues - to vital research processes. Titian’s sample management software, Mosaic, improves throughput, response times, cost efficiencies, error rates, and sample conservation, laying the foundation for discovery and laboratory optimization initiatives. Modular working in R&D labs Story source/Credit: COPA-DATA The automation of laboratories used to be considered very costly and not very flexible, because the workflows are very complex and amounts of data are constantly increasing. Yet, as chemical and pharmaceutical industry product lifecycles become shorter and shorter, the need for digitalization has become urgent. In this article, Christof Franzke, Senior Technical Consultant Key Accounts at COPA-DATA, the industrial software specialist, explains the vital role of the zenon platform in the roll-out of modularization and digitalization in laboratories. oday’s consumers expect technologies to ‘plug and play’ and work seamlessly with other devices in the home — and the same qualities are required in industrial and manufacturing environments. Digitalization has become somewhat easier over the years, thanks to the diversity of automated hardware now available. Yet, on the other hand, it is more difficult to achieve seamless and holistic connectivity across multivendor, multi-tenanted production sites. One way to achieve this is with an industry standard called Module Type Package (MTP). T Product Launches


Microbioz India, August 2023 | 60 Dubbed plug-and-produce manufacturing, MTP is an approach that enables all equipment in a central control system to communicate independently of the typically-fragmented hardware and software usually found in laboratories. Each individual work step is provided by a completed module and researchers in the lab can then combine these modules, quickly and repeatedly, into new applications and processes. What’s more, this can be achieved with just a few clicks and without the need for programming knowledge. Therefore, MTP helps to ease and democratise the whole process. One company that has successfully implemented the MTP approach is Merck KGaA, a German multinational science and technology company. For the first time, Merck is applying its Industry 4.0, Smart Factory and the Industrial Internet of Things (IIoT) approaches, which are formerly tried-andtested in production environments, to laboratories. Modularised process development Configuring a laboratory so hardware and software work in tandem is still a challenge to this day, as many labs still rely on closed, unconnected systems. To alleviate this challenge, Merck KGaA set out to make this automation as simple as connecting a printer to a PC. When selecting system partners for its automation solutions, Merck KGaA attaches the greatest importance to open platforms and the independence of individual applications. For this reason, Merck KGaA and Siemens started a modularization project in 2021 for production facilities that manufacture innovative materials and products in the three business sectors healthcare, life science and electronics. Independent of this, Merck KGaA has taken a further step with zenon from COPA-DATA. The software, which is designed to facilitate MTP standards and support modular production, was introduced to the research and development laboratories of the Electronics Technology Center at Merck’s global headquarters in Darmstadt, Germany Merck KGaA and COPA-DATA’s systems enable the use of MTP standards in a higher-level Process Orchestration Layer (POL). This flexible application of modules is accelerating time to market considerably. The result is more efficient interaction between production and research and development (R&D) and accelerate the market launch of new products by up to 50 per cent. Mass customization Another growing demand in industry is customized products, and MTP can also support this goal. An important benefit of MTP modules is that data can be transferred seamlessly from the laboratory to production. This means formulas currently being developed in the laboratory can enter mass production immediately, without the need to waste effort on manually reconfiguring the production lines, thus enabling faster mass customization. Moreover, Merck KGaA expects that the boundaries between R&D and production will become increasingly blurred in the future. Plug-and-produce is becoming an increasingly established method of production in today’s labs. With advanced industrial automation software like zenon, the chemical and pharmaceutical industry can be ready to cater for shorter product lifecycles, and a need for more customized products through the application of modular production. Product Launches


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Microbioz India, August 2023 | 62 Thermo Fisher Scientific Introduces New Liquid Chromatography Detector Story source/Credit: Thermo Fisher Scientific Thermo Scientific Vanquish Refractive Index Detector completes broad portfolio of reliable LC instruments for routine analytical work hermo Fisher Scientific is providing pharmaceutical and biopharmaceutical research organizations and QC laboratories in the industrial and food and beverage sectors with a new liquid chromatography (LC) detector for simple routine isocratic analysis. The Thermo Scientific Vanquish Refractive Index Detector enables detection of substances that lack UV chromophores and is powered by proven technology. The Vanquish Refractive Index Detector offers customers a highly integrated solution for a range of routine analytical applications when stacked in a Thermo Scientific Vanquish LC system. Completing Thermo Fisher Scientific’s portfolio of dependable, easy-to-operate LC instruments, the new Thermo Scientific Vanquish Refractive Index Detector enables researchers to detect and analyze compounds across many applications, including drug manufacturing, purity analysis of fine chemicals in industry and quality control in food production. The Vanquish Refractive Index Detector extends the Thermo Scientific Vanquish LC detection options for those analytes that lack a chromophore such as carbohydrates, lipids or polymers, allowing users to consistently detect the compounds they need to. The new detector also saves bench space, offers safe leakage control, and enables laboratories to upgrade to modern instrumentation without impacting established methods. Key Applications Biopharmaceutical and pharmaceutical research QC for industrial raw material food and beverage Features/Benefits Extends the range of detection capabilities of the Vanquish LC platform for isocratic separations enabling users to reliably and cost effectively analyze compounds that lack UV chromophores Easy set-up and worry-free operation with a whole system solution that delivers optimized fluidic connections and single-point intelligent controls Seamless method transfers of legacy methods to Vanquish LC systems About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. T Product Launches


Microbioz India, August 2023 | 63 Markes International commercialises new technology that expands applicability of headspace and SPME analyses for food and environmental samples Story source/credit: Markes International Limited Award-winning analytical instrument manufacturer Markes International has announced that it has entered into an agreement with ExtraTECH Analytical Solutions to globally sell ExtraTECH’s newly developed and patented vacuum-assisted caps for headspace microextraction. he caps ingeniously extend the applicability of headspace, SPME and SPME Arrow sample extractions by allowing analytes to be extracted under vacuum conditions with milder heating and agitation than is required using current non-vacuum methods. This avoids the risk of sample degradation and therefore produces a more representative sample profile with much higher extraction sensitivities – an obvious benefit to all analyses. Furthermore, extraction times are typically reduced by half when extraction by vacuum is used, because it lowers the initial pressure in the vial, thus greatly reducing the gas-sample phase resistance, resulting in a much faster transfer of mass analytes to the headspace. Naturally, this translates into significant productivity gains for laboratories – especially those which are high throughput, as is the case within food and environmental sectors, for example. Rachael Szafnauer, product marketing manager of Markes’ sample extraction product lines, said: “The caps unlock the full potential of headspace sampling, allowing fast extraction under mild conditions, and they’re completely re-usable too. All labs need to do is wash and recondition them. So, they reduce waste, time and energy costs. “We’re very excited about how the caps enable analysts to benefit from enhanced extraction capabilities. ExtraTECH’s technology is a great fit with the Markes’ sampling technologies and its Centri instrument portfolio and we’re looking forward to working closely with our customers, helping them to adopt this breakthrough technology.” ExtraTECH’s founder, Elia Psillakis commented: “Our long-standing collaboration with Markes has been driven by our shared passion, determination and commitment to innovation. Now we have brought vacuum-assisted extraction technology to market, I am convinced that our products and methods will benefit laboratories worldwide.” T Product Launches


Microbioz India, August 2023 | 64 Autoclaves Built with User Safety in Mind Story source/Credit: Priorclave Ltd Designing autoclaves that help prevent user accidents is a fundamental aspect of all steam sterilizers leaving the manufacturing facility of Priorclave Ltd. uring a recent visit to a laboratory in North America, Priorclave North America’s CEO came across an incident in which first responders were there for an autoclave accident that had seriously injured at least one faculty member. This wasn’t a student, but an experienced technician. Barbara Wells, Priorclave NA CEO learned later that it was attributed to ‘user error’ because they had opened the door prematurely, while the load was still hot. But that’s a fine line. It’s really a design error. So many US-built autoclaves can be opened before it’s safe. It shouldn’t be possible for user error to result in that sort of injury.” With a Priorclave autoclave built in the UK such an “accident” is not possible. They are built to stringent European Pressure Equipment Directive. They cannot be opened prior to cooling. As Priorclave’s Managing Director Tony Collins explains, “The energy stored in an autoclave at operating temperatures, even at relatively low pressures, is immense. For that reason, autoclaves are subject to tight regulation of their construction and operation in the UK and European Union. Sadly, this is not the case in the United States, which we strenuously disagree with. In contrast to some other manufacturers, we do not produce these less safe US-compliant models, but instead ship every Priorclave with the same EU-mandated safeguards.” Latching onto safety Throughout the entire range of Priorclave autoclaves (40 to 750L chambers) they all incorporate a unique door latch that functions as a mechanical fail safe to our electronic thermal lock system. The door cannot and will not freely open while the chamber remains pressurised. Firstly, the door and larch are extremely durable. Secondly, the unique Priorclave latch is capable of one-handed operation, for improved lab accessibility. But most importantly, this door is extremely safe, it cannot and will not freely open while the chamber remains pressurised. It appears that the US do not set a regulatory standard for the temperature an autoclave chamber must reach prior to opening. That means that a lab tech opening an autoclave built to US regulatory specifications can open the door regardless of how cool—or, much more concerning, how HOT—the chamber or load inside might be. Steam alone can instantly cause severe burns on the face and hands. However, sealed glassware abruptly exposed to sudden temperature drops can explode, sending hot liquids, steam, and broken glass flying all over your lab and the persons standing in front of the chamber. It is nearly impossible to open the door of a Priorclave autoclave without training—and in a teaching environment, that’s exactly what you want. Because if someone hasn’t had even that minimal amount of supervised training, you don’t want them wandering around popping open autoclave doors. These injuries don’t have to happen, especially in teaching and learning environments. Priorclave build their autoclaves so that, even when a user error occurs, the operator’s safety remains top priority. If you’re setting up a sterilizing station in a laboratory and want to ensure a superior level of safety for staff and students, invest in an Priorclave autoclave. They are designed, manufactured to rigorous standard, and fully tested in the company’s dedicated UK production facility. Wherever the destination. All Priorclave have the same build and operation performance. D Product Launches


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Microbioz India, August 2023 | 66


Microbioz India, August 2023 | 67


Microbioz India, August 2023 | 68 PUBLISHED ON: 25th August 2023 RNI NUMBER: UPENG/2017/73675


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