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Biopharmaceutical process development – Trends/ Challenges/Opportunities

Presented by 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

Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech

Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
Recorded Nov 20 2019 64 mins
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Presented by
Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech
Presentation preview: Biopharmaceutical process development – Trends/ Challenges/Opportunities
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  • MES-Integrating Technology, Quality and Compliance – Opportunities, Challenges Feb 18 2020 9:30 am UTC 90 mins
    Sachin Bhandari, GM, Head IT CSV at Sun Pharma
    Full Title: MES –Integrating Technology, Quality and Compliance – Opportunities, Challenges and Strategies.

    Defining the role of MES in using technology to achieve compliance.
    Addressing challenges in implementation of MES in current scenario with focus on Indian companies.
    Technology taking the compliance and quality framework to the next level.
    Organizational strategies to leverage the Power of technology by implementing MES.
  • Rapid Microbial Methods - Reap Benefits And Avoiding Pitfalls Feb 13 2020 3:00 pm UTC 90 mins
    Andrew Bartko, Research Leader at Battelle Memorial Institute
    An overview of the design, validation and implementation of RMM.
    Regulatory advice for RMM implementation
    3 key takeaways from a case study of RMM implementation
  • High-Resolution Characterization of Structure, Interaction, and Miscibility Feb 11 2020 3:00 pm UTC 90 mins
    Eric Munson, Professor and Head at Purdue University
    Full Title: High-Resolution Characterization of Structure, Interaction, and Miscibility of Drug Products

    The local interactions between a drug and its surrounding environment is critical in both small and large molecule formulations. For small molecules, the drug-polymer interaction is needed to ensure that the drug does not crystallize in an amorphous solid dispersion. For proteins, phase separation in lyophilized formulations will lead to reduced stability and the potential for aggregation. In this presentation, the ability to probe these local structures and interactions in both small and large molecule systems will be shown. Case studies will be presented that demonstrate how structural properties (e.g. degrees of interaction, changes in conformation) can impact functional properties such as crystallization and aggregation.

    Eric Munson of Purdue University

    Eric Munson, Ph.D., is currently Professor and Head of the Department of Industrial and Physical Pharmacy at Purdue University. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, to the Pharmaceutical Sciences Department at the University of Kentucky in 2010, where he was the Patrick DeLuca Endowed Professor in Pharmaceutical Technology. In 2018 he moved to Purdue University to become Professor and Head of the department. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on three patents and has published more than 100 research, review, and book chapters.
  • 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.
  • Identification of unknown extractables and leachables using mass spectrometry... Jan 30 2020 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
  • 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 Recorded: Nov 26 2019 60 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.
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities Recorded: Nov 20 2019 64 mins
    Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech
    Presented by 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

    Followed by Quality by Design (QbD) Approach for a Virus Filtration Application
    Presented by Sudhakar Nagaraj, Principal Scientist, SLS – Global Regulatory and  Validation Consulting group at Pall Biotech

    Removal of viruses in bioprocessing applications is a fundamental regulatory requirement, and the use of virus filtration is considered a robust and well accepted component of a virus clearance strategy. With the advent of the International Conference of Harmonization (ICH) Q8 Pharmaceutical Development and Q9 Quality Risk Management guidelines, there is much greater emphasis for filter users to define the filter design space, in addition to performing the mandatory virus filtration validation studies.
    A thorough understanding of the virus filtration design space not only alleviates the risk of viral contamination, but an in-depth understanding of the boundaries of the process parameters ensures the manufacturing process remains in control. In this webinar, we describe an approach to implement QbD principles into virus filtration to create a safe and robust biomanufacturing process.
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum Recorded: Nov 15 2019 67 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 Recorded: Nov 11 2019 77 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 an Industry Perspective presented by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

    Lori Daane is the Director of Scientific Affairs at bioMérieux and has experience in clinical, environmental and industrial microbiology. She is a technical expert on Rapid and Alternative Methods and participates in the sourcing and evaluation of new technologies and potential partnerships in the field of microbial control. She provides scientific support to the Healthcare Business in North America and is responsible for managing feasibility testing and method development for bioMérieux instruments and culture media products.
  • Viral Safety by Design for Cell and Gene Therapy Products Recorded: Nov 11 2019 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 Recorded: Nov 6 2019 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 Recorded: Nov 5 2019 66 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.
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  • Title: Biopharmaceutical process development – Trends/ Challenges/Opportunities
  • Live at: Nov 20 2019 9:30 am
  • Presented by: Kumar Gaurav, AGM (Regulatory Affairs) at Panacea Biotec Ltd and Sudhakar Nagaraj, Principal Scientist, SLS at Pall Biotech
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