2012 PDA/FDA Virus and TSE Safety Conference Session Recordings

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Price of recordings includes:

  • All ten (10) recorded sessions from the 2012 Virus and TSE Workshop (Some recordings and handouts are not authorized for distribution as noted below)
  • Access to 29 downloadable presentation handouts
  • Unlimited playback of the recordings for 60 days from the day of purchase

Session P1: Regulatory Update: Biopharmaceuticals

Over the past 20 years, a significant body of data has accumulated demonstrating virus removal by specific unit operations used for production of mAbs (low pH, AEX, virus filters). The modular approach or the use of in-house data has been proposed and can be justified based on this history for some unit operations; for other unit operations product specific investigations are still needed. Platform data has generally been applicable to investigational products as justified based on data available. This recording discusses such considerations from the regulatory perspective.

Jeffrey Skene, Senior Biologist/Evaluator, Monoclonal Antibodies Division, Health Canada/Canadian Health Network
Marc Martin, PhD, Assessor Viral Safety, Francaise de Securite Sanitaire des Produits de Sante
Yashurio Kishioka, PhD, Reviewer, Division of Biologics, PMDA

Session P2: Current Clearance Technologies

The mechanism of viral clearance and associated critical process parameters (CPP) have been identified for many bioprocess unit operations; other unit operations are not as well understood so far; in these cases of “gaps and opportunities for improvement”  additional studies will help to identify CPPs and provide a deeper knowledge of the mechanism of virus removal.

Olga Galperina, Associate Director, Process Development and Purification, Human Genome Sciences, Inc.
Judy Glynn, PhD, Senior Principal Scientist/Group Leader, Bioprocess R&D, Pfizer, Inc.
Dominick Vacante, PhD,  Research Fellow, Virology Pharmaceutical Development, Johnson & Johnson Pharmaceutical R&D

Session P3: Assessing Virus Clearance of Specific Unit Operations

This recording explores unit operations where the mechanism of viral clearance is understood. High through-put models can be applied to evaluate the impact of a wide range of process parameters on viral clearance.  For the highly understood low pH inactivation step and standard process developed by ASTM is on the horizon.

Kurt Brorson, PhD,  Staff Scientist, Monoclonal Antibodies, CDER, FDA
Herb Lutz, Principal Consulting Engineer, EMD Millipore Corporation
Jeffrey Ucran, Scientist, Purification Process Development, Acceleron Pharma, Inc.  

Session P4: QbD Type Clearance Studies - Role and Structure of Risk Assessments and Design of Experiment Studies

QbD is a high level strategy to ensure product quality and process consistency. Risk assessments and DoE is one of the many tools used to formulate and execute a QbD-based control strategy. This recording provides examples demonstrating the different elements of the QbD approach related to viral safety: risk assessment and generation of DoE viral clearance studies identifying critical production parameter ranges and implementing an adequate control strategy.

Rachel Specht, PhD, Scientist, Process Virology, Genentech, Inc. (Recording and handout not authorized for distribution)
Lisa Connell Crowley, Senior Scientist, Purification Process Development, Amgen, Inc. (Recording and handout not authorized for distribution)
Dayue Chen, PhD, Research Advisor, Bioprocess Development, Eli Lilly & Company

Session P5: Hepatitis E Virus – A New Challenge for Human Plasma and Animal Sourced Products?

Infections with HEV were observed in pigs and also in the donor population for human plasma. The presence of HEV may affect the safety of human plasma products but it is also a risk for raw materials like trypsin derived from porcine tissue. The epidemiological risk and the opportunity to use appropriate model viruses to demonstrate inactivation/removal of HEV during production of plasma products are discussed during this recording.

Martin Groschup, PhD, Head of the Institute, Novel and Emerging Infectious Diseases,  Friedrich-Loeffler-Institut (Recording and handout not authorized for distribution)
Howard Anderson, PhD, Biologist, CDER, FDA
Johannes Bluemel, PhD,  Head of Virus Safety Section, Paul-Ehrlich-Institut
Mikihiro Younoki, PhD, Group Manager, Infectious Pathogen Research and Development  Division, Benesis Corporation  

Session P6: Virus Preparations Used for Clearance Studies

We have learned in the past that quality attributes of virus spike preparations, especially purity, can influence the outcome of virus clearance studies. To address this gap, the PDA Technical Report #47 ‘Preparation of Virus Spikes used for Virus Clearance Studies’ provided therefore recommendations for quality testing and control virus spikes. From a practical standpoint, models of the process-relevant viruses must often be used for the execution of virus clearance studies, but for these studies to be meaningful the model viruses should reflect the properties of the relevant virus. These topics are covered during this recorded session.

Min Zhang, Senior Research Associate, Process Virology, Genentech, Inc. (Recording and handout not authorized for distribution)
Houman Dehghani, PhD, Principal Scientist, Biosafety Development, Amgen, Inc.
Hannelore Willkommen, PhD, President, Regulatory Affairs & Biological Safety Consulting

Session P7: Risk Mitigation Strategies – Raw Materials

The main risk for introducing a virus into a biopharmaceutical production system is related to raw materials, especially animal sourced raw materials. Risk mitigation strategies have therefore utilized elements from all three pockets of the classical safety tripod: selection, testing and pathogen reduction treatment of raw materials to avoid a contamination. Beyond these in-process monitoring of cell metabolism during bioreactor production and in-process testing of cell culture harvests for viral contaminants have proven useful, and are now state-of-the-art. These issues are covered during the recordings of Sessions P7 and P8.

Jack Ragheb, Senior Supervisory Regulatory, CDER, FDA
Captain Rebecca Sheets, PhD, Vaccine Scientist & Regulatory Specialist, NIAID, NIH
Lilly Kong, DVM, Chief Scientific Officer, PrimeraDx
Tara Tagmyer, PhD, Process Scientist, Global Vaccine Technology and Engineering, Merck & Co., Inc.

Session P8: Risk Mitigation Strategies – Raw Materials Continued

Roger Hart, Scientific Director, Amgen, Inc.
Rosemary Versteegen, PhD, CEO, International Serum Industry Association
Raymond Nims, PhD, Consultant, RMC Pharmaceutical Solutions, Inc.

Session P9: TSE Safety of Cell Substrates

Cell substrates used for vaccines or for biotechnology products could be inadvertently exposed to TSE agents from cell culture reagents, animal-derived enzymes, or raw materials used for manufacturing. It has also been proposed that spontaneous development of TSE infectivity could occur in Prp-expressing cell lines.  This recording discusses in vitro mechanisms of TSE infectivity, current state of knowledge about cell substrate susceptibility to TSE agents, and experimental and regulatory approaches to this issue.  Scientific gaps and how to address these are also discussed.

David Asher, MD, Supervisory Medical Offer, CBER, FDA
Pedro Piccardo, Biologist, CBER, FDA
Wendy Osheroff, PhD, Principal Research Scientist II, Grifols Therapeutics,Inc.
Suzette A. Priola, PhD, Investigator, Laboratory of Persistent and Viral Diseases, NIAID, NIH


David Asher, MD, Supervisory Medical Offer, CBER, FDA
Johannes Bluemel, PhD,  Head of Virus Safety Section, Paul-Ehrlich-Institut
Gerald Feldman, Research Biologist, CDER, FDA
Wendy Osheroff, PhD, Principal Research Scientist II, Grifols Therapeutics,Inc.
Pedro Piccardo, Biologist, CBER, FDA
Suzette A. Priola, PhD, Investigator, Laboratory of Persistent and Viral Diseases, NIAID, NIH

Session P10: In Vitro Cell-based Assays for TSE Infectivity

TSE infectivity assays are very informative about process capability for removal of TSE agents.  However in vivo bioassays are the gold standard for TSE infectivity quantitation.  In vivo bioassays are time-consuming, expensive, and require large numbers of animals, which has limited studies of TSE clearance by manufacturing steps.  This recorded session discusses development of in vitro infectivity assays, challenges, and what criteria may scientifically assure that in vitro infectivity assays could be adequate replacement for in vivo assays.

Glenn C. Telling, PhD, Director and Professor, Department of Microbiology, Immunology & Pathology, Colorado State University
Didier Vilette, PhD, Researcher, National Veterinary School of Toulouse
Bruno You, PhD, Manager, Biosafety Studies Team, French Fractionation and Biotechnology Laboratory

Registration contact

Jason E. Brown
Senior Manager, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org