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BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing..

BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing Biopharma API Facilities

Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
Recorded Mar 5 2019 91 mins
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Presented by
Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of Merck
Presentation preview: BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing..
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  • mAb Industry in China: Biosimilars vs. Innovative Biologics Feb 10 2020 8:00 am UTC 90 mins
    Dr Joe X Zhou CEO Walvax Bio Group & Sarah Wang Head of Segment Marketing Biosimilars and Bioconjugations at Sarotrius China
    Presented by Dr Joe X Zhou, CEO at Genor Biopharma, Walvax Bio Group

    Following patent cliffs for Erbitux, Rituxan, Sandosta_n and several big blockbusters, Herceptin, Avastin are now among the next biosimilar targets. This is creating huge potential for biosimilars, prompting innovators to shift their focus to target more emerging markets which remain untapped for many companies. In this presentation, Joe will be sharing with you his vision of the biosimilars market with a focus on China. He will also discuss key considerations for mAb and biologics therapeutic development, providing a broad overview of challenges and opportunities presenting in the market.
     
    1.        Landscape changes of mAb therapeutics
    2.        New targets and process/manufacturing innovation
    3.        Key consideration of mAb industry in China
    4.        Case study: Development strategies of PD-1 mAb as anti-tumor therapeutics in China for global market

    Followed by Biosimilar development—how to deal with the similarity challenge

    Presented by Sarah (Xuyu) Wang, Head of Segment Marketing, Biosimilars and Bioconjugations at Sartorius Stedim Biotech

    Globally we have more than 1000 biosimilars in the pipeline till the beginning of 2019, Sales of mAb biosimilars is also taking up as popular targets being approved both in Europe and US. With the 3rd wave of the biosimilar coming the challenges is still ahead---how to keep the similarity from the beginning of the development to the manufacturing stage and cover the whole lifecycle? With the evolving cell line development platform, good analytical strategy and QbD implementation better similarity will be achieved step by step.
  • Identification of Approaches to Simulated Leachable Studies: What are They? W... Feb 3 2020 3:00 pm UTC 90 mins
    Jason Creasey, Analytical Chemist at GSK
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    The term “Simulated leachable studies” is open to interpretation. I hope to provide a definition of this term and in doing so suggest when they can and should be used. The general aim of such studies is to provide an accurate qualitative and quantitative description of the substances which might be present as leachables in a pharmaceutical drug product (DP) derived from container closure system (and sometimes its manufacturing process) when the drug product is stored up to and including its shelf-life. Simulated studies provide an alternative to analysis of leachables directly in the drug product. A simulated study aims to avoid some of the downfalls of leachable analysis such as; inaccurate analysis of leachables due to interference from drug product and/or formulation elements, availability of stored DP samples, reaching required limits of detection in the DP and time / resource constraints associated with complex method development using DP.
    Simulated leachable studies must be able to accurately simulate the expected leachables in a DP and should be carefully crafted to achieve this. The system used for extraction must have similar propensity to leach from materials under study a drug product and care must be taken not to use system which either leach too much (potentially masking other substance) or too little.
  • Qualification of Raw Materials and Cell Substrates for Biomanufacturing Jan 16 2020 3:00 pm UTC 90 mins
    Maura Kibbey Director, Science & Standards at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck
    The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins.

    Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia

    Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards.  Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.
  • Monitoring Impurities in Biologics Nov 26 2019 3:00 pm UTC 90 mins
    Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 
    The complexity of biotherapeutic products and their manufacturing processes can yield a variety of impurities, which must be monitored and controlled to minimize safety concerns and ensure product quality. These impurities can be broadly grouped into two categories: 1) product-related impurities, such as precursors, aggregates and degradation products, and 2) process-related impurities, such as host cell DNA, host cell protein, and particulates.  This presentation will provide an overview of approaches for monitoring impurities, including a discussion of existing USP standards and standards under development to support impurity testing.

    Presented by Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia 

    Dr. McCarthy is a Senior Manager, Science and Standards within USP’s Global Biologics Department. Diane works with stakeholders to identify areas where standards are needed and define and develop new standards. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
  • Identification of unknown extractables and leachables using mass spectrometry... Nov 21 2019 3:00 pm UTC 90 mins
    Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific
    Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence?

    Extractable and Leachable (E&L) studies on materials used in the manufacturing process and container closer systems of drug products and drug substances are commonly used to assess the risk for patient exposure. Most often LC-MS or GC-MS is used to detect, identify and then quantify extractables and leachables. In general, an analytical evaluation threshold or reporting threshold is set based on a calculated patient exposure. Substances above the set threshold required further investigation if patient exposure exceeds this. Substances can be identified using mass spectral libraries to enable a toxicological risk assessment which considers the risk of patient exposure. However, how confident are we when we identify a substance using spectral libraries? A match with mass spectral libraries, data from orthogonal techniques, fragmentation data and availability of a certified reference standard can increase the level of confirmation. We will discuss an approach for different levels of identification and how to increase the level of confidence of identified extractables and leachables
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities Nov 20 2019 9:30 am UTC 90 mins
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd
    Current trends and regulation affecting Biopharmaceutical Industry
    Journey from Lab scale to Commercial –Overcoming Scalability design hurdles
    QbD-Bringing Improvements in Biologics development and Manufacturing Space
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum Nov 15 2019 3:00 pm UTC 90 mins
    Saly Romero-Torres, PhD, of Biogen and David Lovett & John Mack of Perceptive Engineering
    Full Title: Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

    Presented by Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

    Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

    Followed a Presentation by David Lovett, Managing Director & John Mack, Engineering Director at Perceptive Engineering
  • Just in Time Release of CAR-T Cell Therapies Nov 11 2019 3:00 pm UTC 90 mins
    Irving Ford, Head of CAR T QC Laboratories at Celgene and Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
    Presented by Irving Ford, Head of CAR T QC Laboratories at Celgene

    The views and opinions expressed during the Webinar are those of the presenter.

    Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. As such manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release.
    Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented eliminate the risk or to reduce the risk to an acceptable risk level.
    Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This Webinar will highlight microbial contamination control and testing strategies that can be employed throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.

    Followed by a presentation presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux
  • Viral Safety by Design for Cell and Gene Therapy Products Nov 11 2019 2:00 am UTC 67 mins
    Mark Plavsic, Chief Technology Officer at Lysogene & Archie Lovatt, Life Sciences Biosafety Scientific Director at SGS
    Together with product efficacy, product safety is an essential characteristic of any medicinal product including cell and gene therapy (C&GT) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc) pose constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C&GT product manufacturing process to mitigate risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate the risk while providing a high degree of product safety by design.
  • Pharmaceutical Forensics for Safe Manufacturing and Supply Nov 6 2019 6:00 am UTC 76 mins
    Ravi Kalyanaraman and Jeremy Peters of BMS and Robert Heintz of Thermo Fisher Scientific
    Why Use Raman Microscopy for Pharmaceutical Forensics?
    by Dr. Robert Heintz, Senior Applications Specialist at Thermo Fisher Scientific

    Raman microscopy is uniquely suited for providing essential information for pharmaceutical forensic applications. The use of visible lasers allows for analysis of very small samples with spatial resolutions down to a micron or better. Materials can be analyzed in glass containers and through transparent packaging. Mapping and imaging provides information on the spatial distribution of components as well as particle sizes and shapes. Confocal operation allows for probing inside transparent materials and analyze different layers or inclusions without the need to cut or cross-section the sample. Raman microscopy is non-destructive and preserves the sample for further analysis. Raman spectra can be used not only for the conformation of expected components but also the identification of unknown contaminants or impurities. Spectral features are very sensitive to molecular structure and can be used to distinguish polymorphs and other very chemically similar materials.

    Followed by Pharmaceutical Forensics for Safe Manufacturing and Supply
    by Ravi Kalyanaraman, Director at BMS

    Pharmaceutical Investigations and Technology (PIT) is a group within Global Analytical Technology (GAT) department in the commercial Quality organization within Bristol-Myers Squibb. The PIT group has been a key part in BMS for 30 + years in providing analytical support for commercial manufacturing and in pharmaceutical forensics. This include particulate and foreign matter characterization in pharmaceutical products and screening counterfeit drugs. Several analytical tools and techniques are used by PIT to support the pharmaceutical forensics.This talk will feature all the analytical techniques used by PIT and how the results are used in resolving manufacturing issues and to protect patients from counterfeit drugs.
  • Engineering First Principles: Applications to Pharmaceutical Manufacturing Nov 5 2019 3:00 pm UTC 90 mins
    Bernard McGarvey, PhD Chemical Engineering
    Within the pharmaceutical industry, creating a robust Operational Control Strategy (OCS) is a key step to accomplishing the goals of Quality by Design (QbD). Along the way to developing this robust Operational Control Strategy many problems will be encountered that need to be solved. The use of a First Principles based approach provides value because it improves the effectiveness and efficiency of our problem solving, thereby leading to solutions that are more likely to work without unintended consequences and were created in a faster and more cost effective manner. Based on the author’s experience, a clear definition of what First Principles are will be given (and what they are not!). Areas of opportunity where the application of First Principles is likely to be successful will be described. An outline of a high-level process for implementing a First Principles based approach will be presented. Finally an example of the application of First Principles in the pharmaceutical industry will be briefly described.
  • Upstream Viral Risk Mitigation Strategy for High Titer Biologics Manufacturing Recorded: Oct 17 2019 83 mins
    Aaron Mack, Engineer at Biogen & Dave Kolwyck, Director at Biogen and David Gemmell Senior Process Engineer at Merck
    Presented by Aaron Mack, Engineer at Biogen

    This talk will focus on the risk based approach that Biogen used for determining which raw materials to initially include in its upstream raw material viral risk mitigation portfolio. High Temperature Short Time (HTST) at raw material suppliers is an integral part of this risk mitigation approach. The merits of a risk-based approach to upstream viral safety will be explored, highlighting the HTST pasteurization viral mitigation capability suppliers like Merck have introduced and expanded. Treatment parameters have been detailed in publically available peer reviewed literature and confirmed in specific raw material components prior to implementation in commercial manufacturing processes. Additionally, benefits of decoupling materials with high risk of viral contamination will be reviewed.

    Followed by Implementation of a Robust Upstream Viral Mitigation Strategy for Cell Culture Feeds
    Presented by David Gemmell Senior Process Engineer at Merck (Contact at david.gemmell@emdmillipore.com)

    High temperature short time (HTST) pasteurization is a highly effective method to achieve virus inactivation. This technology has been typically used as an in-house pretreatment tool for high risk bioreactor feeds. The availability of HTST-pretreated feeds minimizes the need to install complex and costly systems in the bioproduction facility, which have significant capital expenditure costs and can become a process bottleneck. The availability and use of complementary virus mitigation strategies minimizes the risk of introducing adventitious agents into the bioreactor, which can impact manufacturing operations and ultimately affect drug supply to patients.

    The webinar details the products and capabilities Merck have developed regarding viral removal utilizing viral filtration or viral inactivation via High Temperature Short Time pasteurization, of high-risk raw material feeds for the biopharmaceutical industries.
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa... Recorded: Oct 16 2019 83 mins
    Dr Lily Koo, Consumer Safety Officer at FDA and Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech
    FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufacturing
    Presented by Dr Lily Koo, Consumer Safety Officer at Food and Drug Administration

    The manufacturing processes for cell therapy products can be highly complex, non-conventional, and product-specific. Aseptic techniques are often required throughout manufacture. The challenge to appropriately and effectively validate aseptic processing requires that industry and regulatory bodies rethink how validation strategies are best applied to this novel class of products. This presentation will address FDA perspective on aseptic process simulation for cell therapy products. It will highlight some unique manufacturing/processing features that are shared among cell therapy products and should be considered during aseptic process simulation study design. The presentation will also cover elements of the traditional validation approach and how they could be appropriately applied to cell therapy manufacturing.

    Followed by Process Control Strategy to Mitigate Contamination Risk of an Aseptic Viral Vector Production
    Presented by Dr Keen Chung, Principal Scientist (Upstream Process) at Pall Biotech

    Adeno-associated virus (AAV) vectors are potent gene therapy vectors, used to deliver therapeutic transgenes to target tissues. Gene therapy clinical trials often require high titer vector preparations to adequately deliver the therapeutic transgene, in great excess of research-level production utilized in many laboratories. To bring the virus into the pre-clinical and clinical phases, Pall Biotech simplified, optimized and scaled-up the current upstream and downstream process of viral vector production to industrial scales using the fully-closed, single-use Xpansion® multiplate seed train bioreactor and the production packed-bed iCELLis® 500 single-use bioreactor. In these processes, it is important to ensure that steps are built into the process to ensure adequate control of adventitious agents.
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies Recorded: Oct 7 2019 80 mins
    Jim Richardson, Sr Scientific Liaison at USP and Horst Ruppach, Ph.D. Scientific Director at Charles River
    Presented by Jim Richardson, Sr Scientific Liaison at United States Pharmacopeia

    Dr. Richardson works in the standards pipeline development group within Global Biologics at USP, leading efforts to develop standards for emerging technologies such as cell and gene therapy. In previous roles at Advanced BioScience Laboratories and Foundation Fighting Blindness, he led translational science activities for the development of vaccines and biologics to prevent and treat infectious and retinal diseases. Trained as a virologist, Jim has also held positions responsible for performing viral clearance testing at Viromed Biosafety and AAV vector development and characterization at Genovo/Targeted Genetics. Dr. Richardson earned his Ph.D. in Biomedical Sciences at the Mount Sinai School of Medicine.

    Followed by Viral Safety Aspects of Raw Materials Used in the Production of Biologics Including Cellular Therapy Products
    Presented by Horst Ruppach, Ph.D. Scientific Director Viral Safety at Charles River's Biologics Testing Solutions

    After a short review of regulations/guidance related to viral safety aspects of raw materials the in principle concept for ensuring viral safety will be outlined. The viral risk profile of a raw material is defined based on the source material, the sourcing process and the subsequent manufacturing and/or purification process. Testing for viruses performed on the start material and/or process intermediates is one way to mitigate the viral risk. Different methods for testing will be presented and the pros and cons discussed. Analyzing the viral clearance capacity of the manufacturing process is another important strategy to reduce the viral risk significantly if applicable. There are, however, experimental challenges sometimes which makes it difficult to demonstrate efficient viral clearance even though the treatment is known to be highly efficient.
  • Cost Considerations for the Application of Continuous Processing Recorded: Oct 2 2019 63 mins
    Narasimha Rao Nedunuri, CEO of CLONZ Biotech and Tania Pereira Chilima, Product Manager at Univercells
    Cost contribution of continuous manufacturing both in operational and capital expenditure in Monoclonal antibody production.
    Evaluating cost of production per gram conventional fed batch vs continuous process.
    Key considerations for adapting continuous process for the production of Biosimilar MAbs.

    Presented by Narasimha Rao Nedunuri, CEO of CLONZ Biotech

    Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, a Biosimilar Monoclonal Antibody company based in Genome Valley, Hyderabad, India.
    He is currently serving the company as the Managing Director & CEO .
    Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing a business division for its Indian subsidiary.
    At CLONZ , a 7 year old start-up, along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.

    Followed by a presentation by Tania Pereira Chilima, Product Manager at Univercells

    Tania Pereira Chilima is a Product Manager at Univercells, responsible for the NevoLine platform for cost-effective viral production. She completed her Bachelors’ degree in Biochemical engineering with focus on protein manufacture at the University College London. She was then awarded an Engineering doctorate, also at the University College London, looking at building and applying decisional tools to help guide the cell therapy industry in selecting commercialization strategies (process, facility design, reimbursement strategies etc.). Her post-doc was sponsored by the Bill & Melinda Gates Foundation, focused on identifying the optimal manufacturing strategies to deliver low cost vaccines.
  • Characterization of Biotherapeutics Recorded: Sep 24 2019 76 mins
    Diane McCarthy, PhD, Senior Scientific Liaison, US Pharmacopeia and Kai Scheffler Product Manager at Thermo Fisher Scientific
    By Diane McCarthy, PhD, Senior Scientific Liaison, Global Biologics, US Pharmacopeia

    Biotherapeutic products are typically characterized by multiple orthogonal methods to evaluate product quality and purity, including assessment of aggregates, variants, and degradation products. For monoclonal antibodies and many other biotherapeutics, analysis of post-translational modifications, such as glycosylation, are also important since these modifications can impact the efficacy, stability, and safety of the final product. This presentation will provide an overview of methods and standards used during characterization, with an emphasis on monoclonal antibodies.

    Followed by Charge Variant Separation Coupled to High Resolution Mass Spectrometry for Routine mAb Analysis

    By Dr Kai Scheffler, Product Manager at Thermo Fisher Scientific

    Biotherapeutics such as monoclonal antibodies are a heterogeneous mixture of structurally similar molecules that differ in mass and charge, referred to as charge variants. Charge variants result from sequence variations and post-translational modifications such as e.g. deamidation and sialylation resulting in species that are more basic or acidic than the main mAb monomer. The heterogeneity can be revealed by charge-sensitive separation methods, such as ion exchange chromatography. The use of MS-compatible buffers allows for online hyphenation to a mass spectrometer. This hyphenated setup provides the chromatographic resolution of ion exchange chromatography coupled to the identification of the separated variants by mass spectrometry.
    In this webinar we will discuss a charge variant analysis (CVA) workflow that entails ion exchange chromatography using pH gradients for protein elution with online mass detection on a high resolution Orbitrap-based mass spectrometer. This workflow enables routine application to a wide range of antibody samples for comprehensive analysis based on a single injection without the need for sample preparation.
  • How to Utilize Design of Experiments (DoE) Principles for the Development of... Recorded: Sep 19 2019 44 mins
    Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca
    Full Title: How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

    Being able to generate accurate and precise analytical data to provide information on product quality in a timely manner is a great challenge facing analytical groups. By adopting a Design of Experiments (DoE) approach, we can overcome many hurdles facing the implementation and adoption of these high-throughput chromatography methods with the data generated being of comparable quality to that from longer lot release methods.

    Presented by Jeremy Springall PhD, Scientist II, Analytical Sciences, R&D Biopharmaceutical Development, AstraZeneca

    Jeremy Springall has worked in the Analytical Sciences group, part of R&D Biopharmaceutical Development, at AstraZeneca for the past five years. His responsibilities include assess new technologies and work processes to support early and late stage development assets as well as being a CMC analytical team lead on several non-mAb projects currently in the AstraZeneca development pipeline. Previous roles include In-process analytical development scientist at UCB and analytical development scientist at Patheon, both in the UK. He holds a Ph.D. in bioorganic and medicinal chemistry and a BSc in chemistry from the University of Bath, UK.
  • From Concept to Market – Unique approaches in Biomanufacturing Recorded: Sep 18 2019 79 mins
    Jincai Li, Vice President of WuXi Biologics Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
    Presented by Dr. Jincai Li, Vice President of WuXi Biologics

    With the rapid growth of the biotherapeutics industry, the need and challenge for high quality, cost efficient production has been increasing as well. At the same time, the number of approved biologics products are also steadily increasing, and more and more products are being developed by small to mid-size biotech companies, with product market size that vary greatly and therefore leading to varying production scale needs. The presentation will talk about the paradigm shifts in today’s facility design and operations, with multi-purpose facility and smaller, modular facility being favored by many companies. In addition, rapid adoption of disposable technology has enabled faster and lower cost facility design & start-up. With the modular, disposable technologies, the unique “scale-out” approach has the advantage of providing highest flexibility to customers while simultaneously lowering tech transfer and scale-up risks. The presentation will also cover the continuous bioprocessing concept and share WuXi’s efforts on this area.

    Followed by a presentation by Kevin Mullen, Sr. Product Manager, Single-Use Systems at Thermo Fisher Scientific
  • Big Data Strategies for Cell Therapy Manufacturing Recorded: Sep 17 2019 76 mins
    Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC and Heidi Hagen, Co-founder and CSO for Vineti Inc
    The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.
  • Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century Recorded: Sep 12 2019 77 mins
    Dr Benoit Ramond, Head of Microbiology & Sterile Technology, Sanofi and Dr David Jones, Director at Rapid Micro Biosystems
    Today Pharmaceutical industry remains conservative for microbiology testing methods and has reluctance to develop and to use Alternative and Rapid Microbiological Methods (RMM) supported by a number of misunderstandings and prejudgments based on the following myths:
    - RMM are not accepted by regulation authorities,
    - RMM will never replace classical microbial methods,
    - RMM will not offer return on investment (ROI),
    - Data generated from RMMs will exceed current specifications and limits involving increase in batch rejections.

    Nevertheless a movement is in progress for the use of new technologies and systems because classical microbial methods, in spite of their long return of experiences and their confidence for the regulatory point of view, have a number of disadvantages such as:

    - Time to results in days to weeks,
    - Results vary with microbial population, media, culture conditions,
    - Lack of reactivity in case of exceeding limit results,
    - Sensitivity could be insufficient giving underestimations in the contamination risk,
    - Existence of confluent growth.

    This webinar provides an overview of the current situation about RMM technologies, regulatory expectations, it proposes some initiatives facilitating the implementation of RMM including a strategy for validation and it gives a projection for the perspectives of the RMMs for the future.
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  • Title: BPOG Risk Based Approaches To Use Of Closed Systems In Renovations Of Existing..
  • Live at: Mar 5 2019 3:00 pm
  • Presented by: Lars Hovmand-Lyster of Novo Nordisk GPO and Ernest Jenness of Merck
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