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Rapid Microbiology Applications in the COVID-19 Era

The implementation of rapid microbiological methods (RMM) has gained significant momentum over the past few years. In particular, the ATMP segment has a desire to release cell and gene therapies using rapid sterility tests to accommodate patient needs and very short drug product shelf life. Additional rapid sterility testing needs are now being fueled by companies who are developing vaccines for COVID-19 clinical trials.

In this webinar, Dr. Michael J. Miller will present an overview of past and future microbiological methods, the current regulatory landscape for rapid sterility testing including recent policy changes, applicable technologies and validation strategies.
Recorded Aug 4 2020 110 mins
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Presented by
Dr. Michael J. Miller, Ulrich Herber and Lori Daane
Presentation preview: Rapid Microbiology Applications in the COVID-19 Era
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  • Global Sterile Transportation and Formulation of an Adjuvant Sep 8 2020 8:00 am UTC 90 mins
    Charlotte Masy, Project Manager at GSK vaccinés and Donald Young, Sr. Product Manager at Thermo Fisher Scientific
    Presented by Charlotte Masy, Project Manager in global support GSK vaccinés

    Followed by an Industry Perspective presented by Donald Young, Sr. Product Manager at Thermo Fisher Scientific

    • Understand how to develop a solution for global use
    • Uncover the challenge of sterile product transportation (E&L)
    • Discuss the pros and cons of single use solutions in this type of application
  • Alternative And Rapid Microbiological Methods: Microbiology Of The 21st Century Sep 8 2020 4:30 am UTC 76 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.
  • Big Data Strategies for Cell Therapy Manufacturing Sep 7 2020 4:30 am UTC 75 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, analyse, 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.
  • Quantification and Control of Amorphous contents by Raman, Application and Case Sep 4 2020 2:00 pm UTC 105 mins
    Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim
    Full Title: Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing

    Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim

    Amorphous regions in crystalline material can have significant impact on bioavailability, processability and stability. Conversely, crystalline material can act as nuclei for recrystallization and resulting in instability of amorphous systems. Raman spectroscopy is sensitive to polymorphic differences and amorphous content in pharmaceutical materials. This make Raman spectroscopy a powerful process analytical technology (PAT), when combined with multivariate modelling, to control the amorphous content in a pharmaceutical process. We will present pharmaceutical case studies showing process-induced amorphization of crystalline drugs across the DS and DP processing steps. In addition, we will compare the kinetics of crystallization of amorphous material when stored at various relative humidity and temperature conditions. The results clearly demonstrate that Raman spectroscopic techniques combined with multivariate methods is a powerful and effective tool for quantitation of amorphous content in crystalline material with applications ranging from API isolation, milling and to multiple unit operations in DP manufacturing. The information generated was critical to determine the root-causes and outline appropriate mitigation measures
  • How to Utilize Design of Experiments (DoE) Principles for the Development of... Sep 4 2020 4:30 am UTC 43 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.
  • Fully Utilizing Closed Systems in Modern BioPharma Facilities Sep 3 2020 2:00 pm UTC 105 mins
    Lars Hovmand-Lyster and Ross Acucena
    Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department

    • Build the roadmap to biopharmaceutical manufacturing and their partners in developing, assessing and verifying unit operations leading to an appropriate facility design that is “right classified”
    • Hear first-hand about this industry-developed document to understand the tools, steps and documents required to adequately risk assess and qualify modern facilities that make use of modular, closed technology
    • Learn how following a methodology results in significant gains in reducing the time to deliver the facilities and CAPEX and OPEX costs
  • The New Annex 1 Revision And The Impact on Using Rapid Methods... Sep 2 2020 2:00 pm UTC 120 mins
    Dr. Michael J. Miller, President of Microbiology Consultants, LLC
    Full Title: The New Annex 1 Revision And The Impact on Using Rapid Methods For Environmental Monitoring

    EU Annex 1 is getting a tremendous makeover and significant revisions enabling the use of rapid methods and changing acceptance levels for environmental monitoring are forthcoming. In this webinar, Dr. Michael J. Miller will present an overview of regulatory and compendial policy changes that encourage the use of rapid methods for environmental monitoring, with a focus on the revision to Annex 1. This will be followed by an actual case study in the use of a real-time rapid method for the instantaneous and continuous detection of microorganisms in an isolator environment.
  • Cost Considerations for the Application of Continuous Processing Sep 2 2020 4:30 am UTC 62 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.
  • Application of USP 665 data to support qualification of single use systems Sep 1 2020 2:00 pm UTC 120 mins
    Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech
    Application of USP 665 data to support qualification of single use systems

    Presented by Ken Wong, Desmond G. Hunt and James Hathcock

    This talk will focus on an overall application of USP starting from risk assessment to qualification of disposable manufacturing systems based on USP data set. All the key principles with examples where these principles need to be satisfied before one can apply the USP data for disposable manufacturing system qualification will be discussed and illustrated. Lastly, different qualification approaches will also be presented to provide broader understanding.

    Followed by a presentation by Desmond G. Hunt, Principal Liaison at United States Pharmacopeia

    Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA

    And Followed by an Industry Perspective presented by James Hathcock, PhD, Sr Director, Regulatory and Validation Strategy at Pall Biotech
  • Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies Sep 1 2020 4:30 am UTC 79 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.
  • FDA Perspective on Aseptic Process Simulation for Cell Therapy Product Manufa... Aug 31 2020 4:30 am UTC 82 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.
  • Engineering First Principles: Applications to Pharmaceutical Manufacturing Aug 24 2020 4:30 am UTC 65 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.
  • Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum Aug 20 2020 4:30 am UTC 66 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
  • Biopharmaceutical process development – Trends/ Challenges/Opportunities Aug 19 2020 4:30 am UTC 63 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.
  • Monitoring Impurities in Biologics Aug 18 2020 4:30 am UTC 59 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.
  • Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder... Recorded: Aug 11 2020 73 mins
    Anders Sparén Associate Principal Scientist at AstraZeneca and Ed Gooding, MicroNIR Photonic Applications Specialist at VIAVI
    Sampling Devices for In-line near Infrared Spectroscopy Monitoring of Powder Blend Homogeneity in Continuous Manufacturing

    In continuous direct compression of pharmaceutical formulations, it is essential to assess the homogeneity of powder blends. This could preferably be done in situ, using fast spectroscopic techniques. In this study, near-infrared spectroscopy was used to study powder blend homogeneity at two positions in the continuous manufacturing process; after the first blender and in the tablet press feed-frame. The focus of the study was on sample presentation at the two positions, and several sampling devices were tested in a laboratory setting using a model formulation, aiming at improving the quality of the NIR measurements. The results for the sampling devices tested are compared and the future implementation in the continuous manufacturing equipment is discussed.

    Followed by Powder Blend Homogeneity Monitoring with the Viavi MicroNIR PAT-W

    The MicroNIR PAT-W wireless NIR spectrometer is used in monitoring blend uniformity in pharmaceutical manufacturing. The PAT-W is a rugged, IP65/67 rated instrument with no moving parts. The PAT-W, with >8 hours battery life, WiFi communication and onboard gravity sensor is well suited for use on tumble blenders in regulated facilities. Viavi’s Linear Variable Filter technology, optical fiber-free design and dual onboard tungsten lamps ensure excellent stability, long lifetime and minimal instrument-to-instrument variability. Viavi MicroNIR Pro software provides data acquisition and chemometric model building, and assures compliance with Title 21 CFR Part 11, USP chapter 1119 and EP chapter 2.2.40. OPC communication and control are also available for use in process environments.
  • High-Resolution Characterization of Structure, Interaction, and Miscibility Recorded: Aug 10 2020 59 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.
  • Identification of Approaches to Simulated Leachable Studies Recorded: Aug 7 2020 80 mins
    Jason Creasey, Managing Director at Maven E&L and Karen Pieters, Ir. Team Leader E&L at Nelson Labs Europe
    Full Title: Identification of Approaches to Simulated Leachable Studies: What are They? When to do Them?

    Presented by Jason Creasey, Managing Director at Maven E&L Ltd. Followed by an Industry Perspective presentation presented by Karen Pieters, Ir. Team Leader Extractables and Leachables at Nelson Labs Europe

    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... Recorded: Aug 6 2020 57 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 Recorded: Aug 5 2020 83 mins
    Maura Kibbey Senior Scientific Fellow, Global Biologics at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck
    Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia
    Followed by an Industry Perspective presented by Martin Wisher, PhD, 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.
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  • Title: Rapid Microbiology Applications in the COVID-19 Era
  • Live at: Aug 4 2020 2:00 pm
  • Presented by: Dr. Michael J. Miller, Ulrich Herber and Lori Daane
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