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PROGRAM CHAIR:
Jeri Ann Boose, PhD - Eurofins Lancaster Laboratories, Inc.
Raymond Nims, PhD - RMC Pharmaceutical Solutions, Inc.

Hazel Aranha
Field Marketing Manager, Sartorius Stedim North America Inc.
Contamination Control in Bioprocessing: Filtration Challenges and
Solutions During Microbial and Viral Clearance Operations

Abstract

Patient safety is at the core of biopharmaceutical manufacturing operations. Sterilizing-grade and virus removal filtration are commonly used for microbial and virus safety assurance. This presentation will discuss the use of sterilizing-grade 0.2 µm-rated and mycoplasma retentive 0.1 µm-rated filters to ensure a sterile product. Filtration challenges in biomanufacturing, factors to consider when choosing pre- and final-filters for different applications, and filter train optimization will be highlighted. Data from filterability trials conducted at different scales in drug manufacturing processes during various process steps will be discussed. We will compare and contrast flow rates, throughput, and yield observed across various commercially available filters from different manufacturers. For virus safety assurance, use of virus retentive filters in downstream and upstream operations will be discussed. Industry ‘stress points’ when using virus filters, as for example, flux decay and pressure interruptions and approaches to optimization of the virus filtration operation with high flux virus filters will be discussed. Additionally, current trends related to use of disposable systems and process automation will be reviewed.

Biography

Hazel has over 30 years' experience that covers industry, academia, and consulting and is a well-known expert in the area of virus and prion clearance from biopharmaceuticals. Hazel has a Master's degree in Virology, a PhD in Environmental Microbiology, and holds a Regulatory Affairs Certification (RAC) for the US and European Union. She has to her credit two books, over 45 publications, and four book chapters.

Donald L. Jarvis, PhD
President, GlycoBac LLC
Virus-Free Insect Cell Lines for Baculovirus-Mediated Recombinant Protein Production

Abstract

The discovery that insect cell lines derived from Spodoptera frugiperda (Sf) and Trichoplusia ni (Tn) are contaminated with viruses raised obvious questions about their biosafety as commercial recombinant protein production substrates. To address this problem, we created and characterized Sf-rhabdovirus-negative (Sf-RVN) and Tn-nodavirus-negative (Tn-NVN) cell lines which have no detectable adventitious viruses. In this presentation, we will describe the features of Sf-RVN and Tn-NVN cells as alternative hosts for use in the baculovirus-insect cell system. In addition, we will present the first direct evidence to show Sf-rhabdoviruses, including a variant with a large X/L intergenic region deletion, are infectious for Sf cells.

Biography

Don Jarvis earned his PhD in virology at Baylor College of Medicine, performed postdoctoral studies with Max Summers at Texas A&M University, established his first independent research program, and was subsequently promoted to Assistant and Associate Professor at Texas A&M. Don then moved to the University of Wyoming in 1998, where he became a full Professor (2001) and continues to address protein processing and broader issues in an effort to improve baculovirus-insect cell technology and advance the baculovirus-insect cell system (BICS) as a recombinant protein production platform. In 2011, Don started GlycoBac, LLC to take advantage of opportunities to fine-tune, commercialize, and apply new BICS and BICS components created in the academic lab.

Cassandra Braxton, PhD
Senior Manager, Global Quality Control Virology, Biogen
A New Era of Adventitious Virus Detection: The Rewards
and Challenges of Implementing Change

Abstract

Viral safety is a critical aspect of ensuring the safety of biological products in the biopharmaceutical industry. Cell culture-based methods are limited in their detection capabilities in that they are only able to detect viruses that cause cytopathic effect, hemadsorption, or hemagglutination. Biogen is exploring next-generation sequencing (NGS) as a novel approach to detecting non-specific adventitious viruses that may be introduced into bulk harvest material for biologic drug substance. This presentation will provide an overview of NGS, its potential for viral safety testing, challenges of implementation in a GMP environment, as well as considerations for implementing this technology in a quality environment.

Biography

Cassandra is the lead for global QC Virology at Biogen, located in Research Triangle Park, North Carolina. Cassandra is spearheading efforts to implement several rapid methods for adventitious virus detection. She joined Biogen in 2014, received her PhD in Microbiology and Immunology from the University of North Carolina at Chapel Hill, and completed a postdoctoral fellowship at Wake Forest University.

Rosemary J. Versteegen, PhD
Chief Executive Officer, International Serum Industry Association (ISIA)
New Testing and Treatment Methods for Animal Sera

Abstract

The International Serum Industry Association (ISIA) is continuing its efforts to provide better information and tools to aid in risk management for animal derived products in use in vaccine and biotherapeutic manufacturing. The ongoing programs in traceability, geographic origin, and gamma irradiation will be reviewed. The new effort on animal age determination will be discussed in detail.

Biography

After receiving her degrees from the University of Glasgow in Scotland, Dr. Versteegen studied at Cambridge University, England, and the National Institutes of Health, Washington, DC. Subsequent to several years as a staff scientist, she joined the biotech start up BRL in 1982. She was with Life Technologies in all its incarnations until the Invitrogen acquisition in 2000, holding positions such as Vice President of New Business Development, Manufacturing, and Regulatory Affairs. After several years as a consultant, she was instrumental in founding the International Serum Industry Association (ISIA) in 2006. She has held the position of CEO since the inception of the association.

Penny L. Post, PhD
Vice President, Regulatory, Protein Sciences Corporation, A Sanofi Company
Viral Safety Testing of Insect Cells for Production of Influenza Vaccines

Abstract

Protein Sciences Corporation, a Sanofi Company, uses the baculovirus expression system technology (BEST) to produce novel vaccines. The BEST provides advantages of speed, cost, and safety. It is generally considered a safe production system, with limited growth potential for adventitious agents that can infect humans. Our Biologics License Application for Flublok®, a recombinant trivalent hemagglutinin (rHA) vaccine produced using BEST, was approved by the FDA on January 16, 2013, making this product the first licensed recombinant influenza vaccine. The method used to manufacture Flublok has the potential for faster start-up of the manufacturing process than traditional egg-based vaccine methods in order to rapidly respond to emerging seasonal or pandemic influenza strains. Additional advantages of this expression system include elimination of the need to handle live viruses (particularly a concern for pandemic influenza) and production of authentic antigen that does not require egg-adaptation. This talk will describe the virus safety testing strategy for our novel expresSF+® insect cell line.

Biography

Dr. Post is Vice President of Regulatory at Protein Sciences Corporation (PSC), a Sanofi Company, in Meriden, Connecticut. She is an experienced and knowledgeable biopharmaceutical professional with a proven track record of successful development and implementation of regulatory strategies, progressing products from pre-clinical through FDA approval, and post-marketing changes. She is the regulatory head that led the team responsible for the filing and FDA approval of Flublok®, the world’s first marketed recombinant influenza vaccine. Dr. Post continues to lead the regulatory team responsible for all filing and post-licensure activities for the Biologics Licensing Application for Flublok. She joined PSC in 2000 and has also performed management roles of increasing responsibility in process development, quality, and manufacturing. She has participated in teams that developed, manufactured, and released recombinant protein products to prevent and treat diseases such as influenza, SARS, hepatitis, diabetes, and AIDS. Prior to joining PSC, Dr. Post was a postdoctoral fellow and associate research scientist at Yale University, where she received funding from the NIH and American Heart Association to support her research. Dr. Post holds a BA in Biology from Middlebury College and a PhD in Biochemistry and Cell Biology from Carnegie Mellon University.

Allen L. Burgenson
Global Subject Matter Expert – Testing Solutions, Lonza Walkersville, Inc.
Endotoxin Detection in Cell/Gene Therapy and Combination Products

Abstract

This presentation discusses endotoxin detection in cell/gene therapy and combination products, including challenges when performing mandatory testing. The presentation will offer several methods to overcome those challenges.

Biography

Allen Burgenson was recently named the Global Subject Matter Expert for Testing Solutions at Lonza Walkersville Inc. in Walkersville, Maryland. Prior to this position he was the Regulatory Affairs Manager at that site for over 14 years. Allen has over 35 years of experience in endotoxin detection, both as an end-user and as a manufacturer of LAL assays, including 13 years as a Steering Committee Member for the LAL Users Group. He is currently the President of the Capital Area Chapter of the Parenteral Drug Association (PDA), and has served on several task forces to publish industry standard technical reports for that organization.

Audrey Chang, PhD
Head, Development Services, Process Solution Services
MilliporeSigma BioReliance® Services
Viral Safety Testing: In Vitro, In Vivo, In Vogue?

Abstract

Adventitious virus assays are performed as part of raw materials testing, cell-line characterization, and lot-release testing of biologicals such as monoclonal antibodies, gene therapy vectors, recombinant proteins, and vaccines. The testing methods follow guidance provided in the 9 CFR (bovine and porcine raw materials testing, and certain vaccine products) or Points to Consider documents (cell line characterization and evaluation of the majority of biologicals). The detection of adventitious viruses is quite rare, especially during evaluation of cell banks and biologicals produced in human, mouse, or insect cell substrates. Broad based methodologies including the in vitro and in vivo assays have been used for decades. From a contract testing organization perspective, the pros and cons of these conventional assays as well as emerging molecular alternatives are presented.

Biography

Audrey Chang earned her PhD in Biology at The Johns Hopkins University, Baltimore, Maryland and has over 20 years of government and industry experience in conducting biological products testing and in managing laboratories. In her current role as Executive Director of Development Services at MilliporeSigma she is responsible for managing and developing a team of PhD level scientific experts that provides greater focus to the development of new services and technologies while providing technical solutions and support to clients and operating laboratories. She and her department work to identify emerging products, technology trends, and global regulatory requirements and champion activities to implement new business plans.

Michael Brewer
Director, Pharmaceutical Analytics, Thermo Fisher Scientific
Detection of Virus in CHO Culture by Ultra-High Multiplex PCR
and Next-Generation Sequencing

Abstract

Viral contamination in cell culture manufacturing processes is a very low probability event, but one with tremendous impact on the manufacturing process and facility when it occurs. Risk mitigation strategies, including intensive characterization of cell banks and seed material, use of animal-free media, single-use bioreactors, thoughtful engineering of manufacturing spaces, and application of advanced viral clearance methods have reduced the risk. Despite all these efforts, there is still a requirement to assess manufacturing cell culture harvests for viral contamination.

Traditional methods of viral detection rely on the infection of indicator cell lines with the test article and monitoring for cytopathic effects in the culture for several weeks. We are developing a straightforward workflow using highly automated systems based on ultra-high multiplex targeted PCR. Amplification of viral genome fragments is followed by sequencing the amplicons generated using the Ion Torrent NGS platform. No propagation or growth of virus is required, eliminating the risks of infection from cross-contamination during viral propagation. Our ultra-high multiplex PCR panels support detection of 89 DNA and RNA viruses in one test. As a safeguard against missing a target due to genetic drift in a single target region and to provide a high level of confidence in the event of a positive test, the PCR primer sets were designed to amplify multiple independent regions of each target virus. Panel A detects 37 viral species (RNA viruses) using 667 primer pairs and panel B detects 52 viral species (DNA viruses) with 348 primer pairs.

The concept workflow starts with the extraction of nucleic acids from the harvest sample on the AutoMate Express™ robot. Manual PCR setup is followed by the manual or automated library preparation on the Ion Chef™ robotic platform. After sequencing on Ion S5™ sequencer, the data will be automatically processed by specialized software and a report will be generated. The time to results from the sample to answer is less than 72h with minimal user intervention during the process. Data from the testing of CHO culture samples spiked with well characterized viral stocks will be reviewed. Initial results demonstrate detection sensitivity of 1–10 TCID 50/mL.

Biography

Michael Brewer is the Head of Pharmaceutical Analytics at Thermo Fisher Scientific, leading the team responsible for product applications including microbiology, analytical sciences, and quality control. The products are fully integrated solutions for glycan profiling, bacterial and fungal identification, mycoplasma and viral detection, and host cell DNA and protein quantitation. Michael has over 30 years' experience in the biopharma industry, including, Scios, Synergen, and Amgen in a variety of roles including discovery research, analytical sciences, and quality control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated, and implemented molecular methods for host cell DNA quantitation, contaminant (mycoplasma, virus, and bacteria) detection, contaminant identification, strain typing, and genotypic verification of production cell lines.

Marcin Łoś, PhD, DSc
Chief Executive Officer, Phage Consultants
An Arms Race Between Bacteria and Bacteriophages — Will This War Ever End?

Abstract

Bacteria and bacteriophages have for billions of years been waging a war, where the number of casualties exceed our imagination. We will never know how many bacterial and bacteriophage species were wiped out as a result of this conflict. During this time, both sides developed various strategies of attack, escape, and counterattack. Some of them are extremely sophisticated, some very simple but effective. During this presentation major bacterial and bacteriophage adaptations will be discussed as well as their potential role in the protection of bacterial cultures against destruction by bacteriophages.

Biography

Marcin Łoś was born in Olsztyn, Poland. He began his studies at the Intercollegiate Faculty of Biotechnology of University of Gdansk and Medical University of Gdansk in Poland. He completed experiments for his MSc at University of Bradford (UK) and defended the MSc degree at University of Gdansk in August 1999. In September 1999 he started his PhD studies in molecular biology at University of Gdansk.

He spent one year at the Fraunhofer Institute for Silicon Technology in Itzehoe, Germany (2002–2003) as a researcher involved in the construction of novel virus detection methods. He obtained his PhD degree in June 2004. In 2011 he also obtained a DSc degree.

In 2007 he founded the company Phage Consultants, in which he holds the position of CEO. The company specializes in prevention and eradication of various contaminants from fermentation facilities and research laboratories and contract research in the field of phage biology, pharmacology, and biotechnology. His main scientific interests are bacteriophage biology and rapid detection methods.

Zachary Beck
Senior Microbiologist, Group Leader, Eurofins Lancaster Laboratories, Inc.
Determining Subvisible Particulate Matter in Therapeutic Protein Injections

Abstract

As the pharmaceutical industry continually evolves, so do the products that they produce. Therapeutic protein injections are becoming more predominant as they are a more naturally sourced treatment of sickness and disease. However, therapeutic proteins can present challenges to pharmaceutical developers because of their unique make-up, and monitoring the quality and integrity of them can be difficult; among them is the particulate matter that is present in these products. Particulate matter can come from many sources, some that may not even be characteristic of the product. Monitoring these throughout the clinical experience is a key part to the eventual release and use of these products. In this presentation, the sources of particulate matter will be examined, as well as technologies to evaluate and monitor particulate matter throughout the life cycle of these products.

S. Steve Zhou, PhD
Director, Virology and Molecular Biology
MicroBioTest, div. of Microbac Laboratories, Inc.
Heat Inactivation of Virus: Expect the “Unexpected”

Biography

Dr. Zhou has served as the Director of Virology and Molecular Biology at MicroBioTest, Div. of Microbac Laboratories, Inc. since 2006. He has more than 14 years of experience in biological safety and disinfectant efficacy testing against viruses, bacteria, and protozoa. He has designed and directed a number of viral inactivation and clearance studies for biopharmaceutical products, medical devices, disinfectants, and clinical antiseptics. Dr. Zhou is an active publisher in peer-reviewed journals and a member of several scientific and trade associations and technical committees. He sits on the editorial board of the ARC Journal of Hematology and is a reviewer for the Journal of AOAC. He has delivered many presentations in scientific conferences. In 2015, he was invited to a scientific expert panel in a micro-organism hierarchy workshop organized by the US Environmental Protection Agency (EPA). Dr. Zhou holds a PhD in molecular virology from Johns Hopkins University School of Medicine. Prior to joining MicroBioTest, he served as a laboratory director of viral clearance at BioReliance; and worked at Schering-Plough (now part of Merck) on anti-viral therapy development.

Kathryn Martin Remington, PhD
Principal Scientist, Field Development Services
MilliporeSigma BioReliance® Services
Demonstration of Porcine Circovirus Type 2 Inactivation by the Low pH Step
of the Trypsin Manufacturing Process Using a New Infectivity Assay

Biography

Kathryn Martin Remington joined BioReliance in 2010 as a Principal Scientist. She assists clients in designing their viral clearance studies as well as providing technical expertise to support Clearance Services. She came to BioReliance from Catalent Pharma Solutions where she established and managed their viral clearance program for seven years. Prior to that, Kathy was the Section Head of the Viral Validation group for Bayer Healthcare. During her 19 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. She has also worked in research, studying drug resistant feline immunodeficiency viruses (FIV). Kathy earned her MS and PhD in Microbiology from the University of Montana.

Antonio J. Scatena
Sr. Sales Representative, Gateway Analytical LLC
I Can See It, Now What Is It? A Guide for What Happens After Visual Inspection

Biography

Antonio has over eight years of experience working in analytical testing positions for several industries, which include the pharmaceutical and medical device industries and criminal forensics. Antonio held positions in quality control for pharmaceutical repackaging and laboratory testing for criminal and industrial forensics before joining Gateway Analytical. He held roles as both a scientist and laboratory manager at Gateway Analytical before moving into business development. Antonio received his BS in Biochemistry from the Indiana University of Pennsylvania. He is currently a senior sales representative for Gateway Analytical and acts as a technical resource to help companies solve issues involving drug formulation and medical device development and foreign particulate identification and source determination investigations.

Sarah Meunier, PhD
Research Associate and Lecturer, University of Waterloo
Ultraviolet Irradiation of Adventitious Agents for the Biopharmaceutical Industry

Biography

Sarah began her engineering training at the University of Ottawa where she completed a double bachelor program in Chemical Engineering and Computing Technology with Cooperative Education. Upon graduation, she began a master’s degree researching the development of a rotating corrugated drum photocatalytic reactor for water treatment. After completing her master’s, she moved to Waterloo, Ontario to complete a PhD program at the University of Waterloo focusing on an immobilized enzyme packed bed reactor for biodiesel production. Currently, she is a postdoctoral fellow at Trojan Technologies in London, Ontario researching the development of UV reactors for biopharmaceutical applications. She also lectures part-time at the University of Waterloo.

Michael Burdick, PhD
Associate Director, Global Pathogen Safety Support, CSL Behring
Differential Retention of Parvoviruses by Virus Filtration
Shayn Armstrong
Laboratory Director, Bionique Testing Laboratories, Inc.
New Topics for an Old Mycoplasma Technology


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