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Just in Time Release of CAR T Cell Therapies During Covid-19

Presented by Irving Ford, Site QA Head multi-product CAR T facility at Bristol Myers Squibb
Recorded Nov 29 2021 78 mins
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Presented by
Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux
Presentation preview: Just in Time Release of CAR T Cell Therapies During Covid-19
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  • The exogenously driven disruption of Bioprocessing Sep 15 2022 2:00 pm UTC 120 mins
    Christos Varsakelis, at The Janssen Pharmaceutical Companies of Johnson & Johnson
    Industry 4.0 comes with an impressive collection of assets and capabilities. However, although the degree of applicability in Bioprocessing is high, the origin of these technological innovations is exogenous. This is not without implications and in this talk we are concerned with their identification and quantification. We commence with the onboarding of an exogenous technology problem. Industry 4.0 tools have been developed with different objectives in mind. Integrating them in Bioprocessing requires a critical a priori analysis of similarities and transferability.  We then move on to address a fundamental question: is this exogeneity positive or negative for Bioprocessing?  The answer is drawn from historical case studies, stemming from different industries. This naturally leads us to the concept of  the fallacy of division and the associated dangers of disruption. Finally, we go a step further and explore how the addition of 4.0 in Bioprocessing can alter the core business activities and what this implies for the insourcing vs outsourcing dilemma that both big and small corporations have to face.
  • Shortages of critical raw materials and managing changes and substitutions Apr 28 2022 2:00 pm UTC 120 mins
    Frances Sexton, TS/MS Bioprocess Chemist, Materials Management, Eli Lilly
    Raw materials play an integral role in pharmaceutical manufacturing to support target product profile. The availability of critical raw materials has been a recurrent theme in recent years and the recent COVID-19 pandemic has introduced additional layers of complexity in this already challenging environment.  Among those COVID-19 related challenges are; a lack of real-time supply chain transparency; the need for businesses to flex with a surge in material demands; the need to manage an increase in supplier change notifications etc.  The development of risk mitigation measures to circumvent raw material stock outages serves as a primary component of a robust business continuity plan.

    We will outline pragmatic strategies that may serve to reduce the risk of material supply chain shortages.  Such strategies are key to effective and efficient product commercialization.  This case study will illustrate the value of a practical risk-based approach towards managing raw material substitutions and outline key considerations in evaluating and executing raw material substitutions and second sourcing strategies.  A sample decision tree approach will be presented designed to enable right-sizing technical evaluation of raw material substitutions across both compendial and non-compendial raw materials.  The appropriate application of prior knowledge in this regard will also be discussed.
  • Data as an asset – what does this means to you? Apr 12 2022 2:00 pm UTC 120 mins
    Christos Varsakelis, at The Janssen Pharmaceutical Companies of Johnson & Johnson
    Social media frequently depict data as the new oil. Whilst Industry 4.0 is data centric, in the sense that it promotes a data driven “piloting of the vessel”, quotes like the above should be interrogated or at least taken with a pinch of salt. There is no doubt that data constitutes an asset but the fundamental value of this asset, to invoke a stock market jargon, remains not well understood.  Biopharma has adopted the mentality that it sits on a pile of cash and has ostensibly embarked on a journey to capitalize on its data.  However, although the market provides an excellent mechanism to evaluating an asset, the strategy of most corporations is paradoxical in that it does not aim to quantify demand but rather to tailor it to its traditional views. This talk will attempt to explore the data market by uncovering not only conventional ways to capitalize on data but also tapping onto drastically unconventional proposals that throw biopharma out of its comfort zone. The results of this exercise corroborate the suspicion that realizing the fundamental value of data as an asset requires revising the traditional ways of working.
  • CMC Progression from Early to Late Phase... Mar 23 2022 2:00 pm UTC 120 mins
    Sarah Thomas, Vice President of Quality at REGENXBIO Inc.
    Full Title: CMC Progression from Early to Late Phase – Practical Considerations for Gene Therapy

    The principles for developing traditional biologics are well established, but do not always translate well to cell and gene therapy products.  Creative yet practical adaptations are necessary to advance gene therapy programs toward licensure.  During this presentation we will explore three key areas where practical adaptations are required:

    Building toward the commercial process: change control and managing product evolution for non-traditional development pathways, comparability challenges and clinical exposure
    Maturation of analytics – the level of product understanding expected as programs advance, method advancement from early to late phase, evolving regulatory expectations
    Finding the right partners – finding the right match in terms of not just technical ability, but also phase-appropriate GMP compliance and client service infrastructure; the impact of the Covid-19 pandemic on material and service providers
  • An impurity detected in a stability study... Mar 15 2022 2:00 pm UTC 120 mins
    Petra Booij, Investigator bij GlaxoSmithKline
    Full Title: An impurity detected in a stability study: Did we miss anything in our E&L risk assessment? Extractable and leachable (E&L) testing are required to identify substances that can or will migrate into the drug substance or drug product during the manufacturing process, storage and administration to assess the risk for patients being exposed to these substances. Stability testing is required to provide evidence on how the quality of a drug substance or product varies over time. E&L testing and stability testing can be run in parallel, but the conditions and detection techniques used for screening can be different. Although stability testing focuses on the quality of the drug substance or product by investigating the degradation products, it can occur that compounds are detected which are leachables. In this case study an unknown compound was detected during stability studies using LC-UV which could not be linked to a degradation product and was suspected to be a leachable. The question was raised if the unknown compound could be linked to extractables or leachables and if there was a potential risk for patient safety and drug product quality. E&L studies require complementary analytical techniques to screen for a wide range of compounds and the experimental design needs to be considered and stability studies can be set-up differently. This case study shows challenges in identification when using complementary techniques and discusses uncertainty in identification of leachables.
  • Holistic Approach to the Industry 4.0... Mar 14 2022 2:00 pm UTC 120 mins
    Christos Varsakelis, at The Janssen Pharmaceutical Companies of Johnson & Johnson
    Full Title: Holistic Approach to the Industry 4.0 Investment Breaking Down the Fences Between R&D & Manufacturing

    Bioprocessing 4.0 is a novel terminology that is typically identified as Industry 4.0 avatar in Bioprocessing. The overall concept of Bioprocessing 4.0 has been increasingly gaining traction and this trend is robustly projected to remain strong. Interestingly, even in business fora, the majority of discussions on Bioprocessing 4.0 are predominately technical. Emphasis is placed on the exposition of existing capabilities, and those under development, a situation reminiscent to marketing campaigns. Even when brought up, business arguments remain largely qualitative which, in turn, constitutes a conundrum given that Bioprocessing 4.0 is de facto an investment agenda. In this talk, we deviate from the technical land and re-examine Bioprocessing 4.0 through the lenses of an informed investor.  We show that optimizing Return on Investment requires the adoption of a holistic approach to Bioprocessing 4.0; an approach that simultaneously considers R&D and manufacturing.  However, the usual fences between R&D and manufacturing, a manifestation of siloing that plagues big corporations,  can jeopardize the overall business case. The main corollary of our analysis is that success predicates strongly on treating R&D and manufacturing as a continuum.
  • Regulatory Strategies For Rapid Sterility Testing... Mar 7 2022 3:00 pm UTC 120 mins
    Dr. Michael J. Miller, at Microbiology Consultants, LLC and Lori Daane, at bioMérieux
    Full Title: Regulatory Strategies For Rapid Sterility Testing of Gene and Cell Therapy Products

    The need to utilize rapid sterility testing is gaining momentum within our industry, especially for short-life drugs with an immediate patient need, such as advanced therapy medicinal products (ATMPs; cell and gene therapies). This webinar will explore the challenges of manufacturing and releasing ATMPs and the benefits of implementing rapid sterility test strategies. In particular, we will discuss valorous global regulatory initiatives and policy changes that support the use of rapid sterility tests for these types of products, as well as the introduction of compendial chapters providing guidance for validation and implementation. We will finish with case studies on how rapid sterility validation studies may be performed.
  • Overcoming Antibody-Drug Conjugate (ADC) Process Development... Feb 23 2022 8:00 am UTC 120 mins
    Dr. Jincai Li, Vice President of WuXi Biologics
    Full Title: Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

    Presented by Dr. Jincai Li, Vice President of WuXi Biologics
  • In-line monitoring of surfactant clearance... Feb 15 2022 3:00 pm UTC 120 mins
    Marina Kirkitadze, Head of Process Support & PAT Platform, Analytical Sciences at Sanofi Pasteur
    Full Title: In-line monitoring of surfactant clearance in viral vaccine downstream processing
  • We Are Going Back to the Future with Rapid Methods Feb 14 2022 3:00 pm UTC 120 mins
    Dr. Michael J. Miller, at Microbiology Consultants, LLC and Lori Daane, at bioMérieux
    Rapid methods have been available to the pharmaceutical industry for decades. And although global regulations have changed to encourage their use, especially for rapid sterility testing, and the compendia enhanced their chapters to promote the validation and implementation of these technologies, only a handful of firms have embraced rapid methods to their fullest potential. This presentation, which will include audience participation, will once and for all disprove the misconceptions and address any confusion surrounding rapid method applications and acceptance. We will also discuss the most current enablers, including guidance from USP, Ph. Eur., Annex 1, FDA and EMA, and share successful case studies where rapid methods have had the greatest impact.
  • Handling mutagenic extractable and leachable compounds released from devices Feb 10 2022 3:00 pm UTC 120 mins
    Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs
    Genotoxic compounds can be released from some medical devices during their clinical use. The ISO 10993-17:2002 standard outlines steps to assess the risk posed by patient exposure to genotoxic compounds released from device materials. It is important to note; however, that the ISO 10993-17 standard is currently undergoing revision and the procedures for conducting a toxicological risk assessment of genotoxic compounds are likely to change following revision of the standard. This talk will outline the proposed changes to the ISO 10993-17 standard regarding methods to assess the risk posed by patient exposure to genotoxic compounds released from medical devices and will describe steps to mitigate the risk using risk management strategies. The talk will also briefly address how Carcinogenic, Mutagenic, and Reproductive (CMR) compounds will be handled in Europe under the new Medical Devices Regulation 2017/745/EU.
  • Applications of industry 4.0 concepts in continuous pharmaceutical tablet... Jan 27 2022 3:00 pm UTC 120 mins
    Presented by Dr Ravendra Singh, Research Faculty at C-SOPS at Rutgers University, NJ, USA
    Full Title: Applications of industry 4.0 concepts in continuous pharmaceutical tablet manufacturing process

    Currently, Industry 4.0 concepts are being applied to pharma industry to achieve Pharma 4.0 paradigm. Pharma 4.0 reduces the time and resources needed for continuous pharmaceutical manufacturing and also improves the product quality and production consistency. It has many advantages but also have bigger challenges on the applications of artificial intelligence (AI)/machine learning (ML), and advanced control systems because of different level of complexities.

    Four machine learning (ML) models have been trained to predict the response of continuous pharmaceutical manufacturing process and the performance of these ML models has been compared. The investigated ML methods are long short term memory (LSTM), 1D convolution neural network (CNN), random forest (RF), and artificial neural network (ANN). The best performing ML model is then implemented into the continuous pharmaceutical tablet manufacturing process. An advanced model predictive control (MPC) system coupled with an RTD based control system has been also implemented in the continuous pharmaceutical manufacturing (CPM) pilot-plant [1]. The CPP’s and CQA’s are controlled in real time using advanced model predictive control (MPC) system while the none-confirming products are diverted in real time in waste using RTD based control system to assure the final CQA’s of qualified tablet lots. All the relevant data generated during continuous manufacturing has been systematically collected, stored and organized in a data hub (OSI PI) and cloud system as per industry 4.0 standard.

    The objective of this presentation is two-fold; first to highlight the pharma 4.0 technology and then demonstrate the development and implementation of machine learning (ML) and advanced control systems into continuous pharmaceutical tablet manufacturing process.
  • CCAB: A universal tool to address the risk of microbial impurities... Jan 26 2022 6:00 pm UTC 120 mins
    Dr Friedrich von Wintzingerode, QC Lead iNeST, Roche and Eelo Gitz, Head product development at Sanquin Reagents
    Full Title: CCAB: A universal tool to address the risk of microbial impurities in parenteral drug manufacturing including ATMPs

    For parenteral drugs such as monoclonal antibodies, injectable oligonucleotides, and RNA- or DNA-based ATMPs, filtration using pore sizes ranging between 0.02 and 0.2 µm is the method of choice to reduce bioburden and ensure terminal sterilization of the drug product. While filtration efficiently removes intact microbial cells it does not remove subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases. These microbial impurities can have a significant impact on product quality and patient safety when critical loads are exceeded during a contamination event. The CCAB approach described here enables a comprehensive assessment of these risks.
  • Single Use Process for Production of AAV Gene Therapy Products Jan 26 2022 3:00 pm UTC 120 mins
    Lance Marquardt, Associate Director -Upstream Processing Gene Therapy, Hopewell Biologics Manufacturing at PTC Therapeutics
    An overview of single use manufacturing for the production of AAV gene therapy products with comparisons to traditional monoclonal antibody production.  Specific challenges of scaling up AAV production and considerations to accommodate a range of demands of differing gene therapy products will be discussed.  I will review the reasons for starting and the challenges of being the inhouse manufacturing facility for a rapidly growing company.  The challenges of making non-COVID products in the era of Warp Speed along with future commercial production comparing fully single use with a hybrid facility will be explored.
  • Rapid methods- The Next Phase : A Framework For Multi-Product Adoption... Jan 12 2022 3:00 pm UTC 120 mins
    Miriam Guest, at AstraZeneca UK and Ulrich Herber at Charles River
    Full Title: Rapid methods- The Next Phase : A Framework For Multi-Product Adoption Of Rapid Sterility Testing

    The adoption of rapid sterility testing has significant benefits to the pharmaceutical industry; providing early notification of control drifts, a non-subjective answer to the sterility test and a faster time to product release.  However the challenges of adoption can be daunting.  By enhancing the benefits of regulatory interactions in the development phases, a complex post-approval regulatory change can be mitigated, however with limited material available, the outlined strategy provides a robust way forward to adopt rapid sterility and capture the benefits.

    AstraZeneca considered the global operations of a major pharmaceutical company in the adoption of rapid sterility.  Utilising risk assessment tools and a holistic overview of pharmaceutical clean room flora, a representative panel of global microorganisms was selected.  Variability between product, consumables, organisms origin & status and testing sites was factored in. 

    Focused studies were performed and data will be shared to provide an outline of the operating range that has been verified for the ATP Bioluminescence based sterility test.

    The presentation will outline a vast & powerful data set which supports the robustness of the rapid sterility test, to enhance our product understanding.  Additional data was leveraged in time to result studies for “challenging organisms” such as slow growers.
  • Just in Time Release of CAR T Cell Therapies During Covid-19 Recorded: Nov 29 2021 78 mins
    Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux
    Presented by Irving Ford, Site QA Head multi-product CAR T facility at Bristol Myers Squibb
  • Near-infrared spectroscopy for monitoring... Recorded: Nov 16 2021 79 mins
    Marina Kirkitadze, at Sanofi Pasteur, Gabriella Gerzon, PhD at York University, and Dean Roberts Director at Bruker Corp
    Full Title: Near-infrared spectroscopy for monitoring Maillard reaction and critical process parameters of a C. tetani bioprocess
  • Using PAT to accelerate and optimize the process development Recorded: Nov 4 2021 79 mins
    Lizbeth Martinez, Ph. D, at Novartis Basel Switzerland and Emiliano Genorini, at Viavi Solutions
    Full Title: Using PAT to accelerate and optimize the process development of solid dosage forms.

    Near-infrared spectroscopy (NIRS), as one of the major PAT tools, has attracted lot of attention from the pharmaceutical industry. NIRS can analyze samples without previous pretreatment, therefore reducing or eliminating wet chemistry analysis. During development of the drug product process, each unit operation brings challenges that need to be assessed in order to prevent compromising the quality of the final product. Two examples of real PAT applications are presented in this study. The first case tackles the challenges of process development in an international environment, with different locations for manufacture and traditional analytics. Showing how PAT enables a lean evaluation of the product quality, better understanding and supports process transfer. By means of in-line monitoring of the blending process, at-line content uniformity determination on high number of tablets and by helping the troubleshooting of segregation. The second case describes in-line monitoring by NIRS for assay determination in a wet met media milling process of a nano-suspension. NIRS proved to be a versatile and valuable tool for the pharmaceutical development and manufacturing of solid dosage forms.
  • Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control... Recorded: Oct 28 2021 115 mins
    Presented by Dr. Zlatibor Velickovic PhD at Royal Prince Alfred Hospital and Alan Hoffmeister at Charles River Laboratories
    Full Title: Validation Of Endotoxin Testing For CAR T-cell Manufacturing Quality Control & Benefits of Cartridge Technology

    During manufacture of CAR T-cells there is a risk of contamination of the final product and/or materials with endotoxins. Endotoxins are lipopolysaccharide molecules produced by gram-negative bacteria that can cause toxic reactions in patients and lead to serious complications. 

    Endotoxins can be detected reliably by the limulus amoebocyte lysate (LAL) test. Endosafe nexgen-PTS, (Charles River) is a portable system designed to read cartridges loaded with LAL reagents and endotoxin control. Each cartridge is supplied with a predetermined spike recovery with two sample and two spiked channels enabling quick and easy endotoxin detection.

    Materials used in cell manufacturing may interfere with the test and therefore validation of bacterial endotoxin testing (BET) is mandated for each cell product. We’ll present the validation approach for endotoxin testing using Endosafe nexgen-PTS designed to meet Australian regulatory requirements.

    In this webinar, you will learn from our experts:

    Introduction to cartridge technology and its benefits
    How the Endosafe nexgen-PTS provides a rapid quantitative method for Endotoxin detection in CAR T-cell products.
    Why Maximum Valid Dilution (MVD) needs to be calculated and validated for each CAR T-cell product formulation and volume of infusion.
    Why it is important to perform interference testing using I/E cartridges and serial dilutions of the CAR T-cell product up to the MVD.
  • Advances in the Purification of Antisense Oligonucleotides Recorded: Oct 27 2021 61 mins
    Robert Gronke, Ph.D., Senior Principal Scientist, at Biogen and John Cyganowski, Director of Customer Application, Merck
    Following on the commercial success of Spinraza® (the first successful treatment for patients with spinal muscular atrophy), antisense oligonucleotides (ASO) are now an important part of Biogen’s drug portfolio that enables us to better treat neuromuscular diseases. Development of the ASO process employs orthogonal chromatography to achieve industry high purities while maintaining good yield along with detritylation and UF/DF steps.  This purification platform process is all aqueous based on green chemistry principals that easily fits into our existing biologics manufacturing facilities. To date, we now leverage this ASO platform process to purify 13+ ASO molecules that contain different sequences, chemistries, and most recently incorporating conjugation reactions.

    Having completed process characterization for our lead ASO candidate, we have achieved a greater understanding of the process, its capabilities to clear process and product related impurities and understand the mechanisms that control the chromatography. On the manufacturing side, Biogen recently completed at scale PPQ validation batches of an ASO clinical candidate.  Cases studies and learnings will be presented on results from characterization studies and PPQ batches.
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  • Title: Just in Time Release of CAR T Cell Therapies During Covid-19
  • Live at: Nov 29 2021 3:00 pm
  • Presented by: Irving Ford at Bristol Myers Squibb and Lori Daane at bioMérieux
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