Cambridge Healthtech Institute’s Third Annual
Virus and Pathogen Clearance and Safety in Biologics:
Detection, Clearance, Risk Mitigation and Management
Part of CHI's Ninth Annual The Bioprocessing Summit
August 24-25, 2017 | Westin Copley Place | Boston, Massachusetts

Recent incidents due to adventitious agents in manufacturing processes have resulted in an increased regulatory scrutiny and the need for new technologies and better risk management strategies to ensure safety of biologics. The Third Annual Virus and Pathogen Clearance and Safety in Biologics will discuss technical and regulatory aspects of detection, risk mitigation and risk management of virus and other pathogen contamination in biopharmaceuticals that come from raw materials, cell culture processes, bioreactor contamination and downstream processing. There will also be discussion on new technologies for detection of new pathogens.

Final Agenda

Thursday, August 24

11:30 am Registration Open

12:15 pm Enjoy Lunch on Your Own

1:15 Dessert Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

RISK MANAGEMENT, STRATEGIES & CASE STUDIES

1:55 Chairperson’s Remarks

Mark Plavsic, Ph.D., CTO, Lysogene

2:00 A Risk Based Approach to the Management of Virus Risk in a cGMP Manufacturing Facility

Anne Stokes, Ph.D., GSK Fellow and Director, TSE and Virus Control, GMP Operations, Biopharmaceutical Development and Supply, GlaxoSmithKline

GSK has a comprehensive viral safety program to produce biopharmaceuticals which uses a three-fold complementary approach: (1) Control of Raw Materials, (2) In Process Testing and (3) Demonstration of the capability of processing steps to clear virus. These and other considerations are tightly managed through a comprehensive risk management program that has resulted in confidence that the materials that are supplied to patients are free from virus contamination.

2:45 Viral Safety Testing of Insect Cells for Production of Influenza Vaccines

Penny Post, Ph.D., Vice President, Protein Sciences Corporation

This presentation talks about uses of the baculovirus expression vector system and insect cells to produce novel vaccines. The baculovirus expression system technology provides advantages of speed, cost, and safety. Our recombinant seasonal influenza vaccine Flublok® was FDA approved in 2013, making this product the world’s first approved recombinant influenza vaccine. This talk will describe our virus safety testing strategy for our novel expresSF+® insect cell line.

3:15 Process Control Strategy for Gene Therapy Products

Mark Plavsic, Ph.D., CTO, Lysogene

A good process control is important for the successful development of the gene therapy products. In this presentation, we will discuss the importance processes in gene therapy based product and design of a good process control strategy.

3:45 Comparison and Trend Analysis of Virus Retentive Filter Performance in Viral Clearance Studies

Kitti Neumann, Senior Manager, Process Evaluation, Charles River Laboratories

Given current industry expectation for virus retentive filtration, viral clearance study results have been evaluated for specific performance trends over time. Based on Charles River database information dating back to 2014, this virus removal capacity has been evaluated, with a focus on filtration results obtained for selected filter vendors. In addition, this trend analysis will include reference to study design elements that have influenced these results.

4:00 Refreshment Break

4:15 Industry Approaches to Facility Segregation for Viral Safety

Paul Barone, Associate Director, BioMAN and CAACB, MIT Center for Biomedical Innovation

The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) has begun a project with the following goals:

• Define “pre- and post-viral clearance zones” and “pre- and post-viral clearance materials”
• Define “functionally closed” manufacturing systems
• Identify an array of facility segregation approaches used for the safe and effective production of recombinant biologics as well as plasma products

This presentation will discuss the results of this collaborative endeavor to date.

4:45 PANEL DISCUSSION: Impact of Alternative Cell Lines and Human Cell Lines on Viral Safety

Moderator:

Mark Plavsic, Ph.D., CTO, Lysogene

Panelists:

Paul Barone, Associate Director, BioMAN and CAACB, MIT Center for Biomedical Innovation

Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC

Anne Stokes, Ph.D., GSK Fellow and Director, TSE and Virus Control, GMP Operations, Biopharmaceutical Development and Supply, GlaxoSmithKline

Penny Post, Ph.D., Vice President, Protein Sciences Corporation

5:15 Close of Day

Friday, August 25

8:00 am Registration Open and Morning Coffee

RAW MATERIALS SAFETY

8:25 Chairperson’s Remarks

Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC

8:30 Raw Materials as the Source of Porcine Circovirus, Porcine Hepatitis E Virus and Mycoplasmas; Strategies to Prevent and Remove from Biologics

Barbara J. Potts, Ph.D., Senior Consultant, Potts and Nelson Consulting, LLC

Strategies will be presented to prevent the contamination of biologics with porcine circovirus, porcine hepatitis E virus from contaminated porcine raw materials and from mycoplasmas found in peptones and bovine sera. Removal and inactivation methods will be presented that have been successful including a case study of porcine circovirus in pepsin.

9:00 FEATURED PRESENTATION: Management of Risks Associated with Animal Derived Materials

Rosemary J. Versteegen, Ph.D., CEO, International Serum Industry Association

UPSTREAM & DOWNSTREAM PROCESSING AND PURIFICATION

 9:30Leveraging Modular Claims for Viral Clearance

Brad Stanley, Ph.D., Scientist II, Technical Development, Biogen

Extensive experience in performing validation studies and improvements in scientific understanding of viral clearance and inactivation mechanisms have facilitated the use of claims that rely less on molecule specific validation studies. Leveraging published ASTM standard practices for low pH virus inactivation and internal data demonstrating robustness of detergent inactivation and virus filtration across programs will be discussed as part of an integrated strategy to ensure viral safety.

10:00 Networking Coffee Break

10:30 Evaluation of Low pH Viral Inactivation and Viral Filtration Data from Multiple Company Collaboration

Xinfang Li, Principal Scientist, Process Science and Engineering, ImmunoGen, Inc.

Considerable resources are spent within the biopharmaceutical industry to perform viral clearance studies which are conducted for widely used unit operations that are known to have robust and effective retrovirus clearance capability. The collaborative analysis from the members of BioPhorum Development Group Viral Clearance Working Team considers two common virus reduction steps in biopharmaceutical processes: low pH viral inactivation and viral filtration.

11:00 Viral Clearance Prediction through the Use of a Non-Infectious MVM-Virus Like Particle

David Cetlin, Founder & CEO, MockV Solutions LLC

Due to the infectious nature of live viruses, viral clearance “spiking studies” are typically conducted in specialized BSL-2 facilities at CROs. The costs and logistics associated are major hurdles during downstream process development activities. A non-infectious Minute Virus of Mice - Virus Like Particle (MVM-VLP) was generated for use as an economical spiking surrogate. Discussed here are the results from a side by side MVM vs. MVM-LVP nanofiltration spiking study.

11:30 Isolation and Characterization of Virus-Free Insect Cell Lines for Baculovirus-Mediated Recombinant Protein Production

Donald Jarvis, Ph.D., Professor, Molecular Biology, University of Wyoming

Insect cell lines most commonly used as hosts for baculovirus-mediated recombinant protein production, derived from Trichoplusia ni (Tn) and Spodoptera frugiperda (Sf), are commonly contaminated with adventitious viral agents. The Tn contaminant was identified as Tn cell line virus (TnCLV), whereas the Sf contaminant was identified as Sf-rhabdovirus (Sf-RV). In this talk, we will describe the isolation and characterizion of TnCLV- and Sf-RV-negative Tn and Sf cell lines, respectively.

12:00 pm Sponsored Presentation (Opportunity Available)  

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:15 Session Break

TOOLS FOR DETECTION OF EMERGING VIRUSES AND PATHOGENS

1:25 Chairperson’s Remarks

Cassandra Braxton, Ph.D., Scientist II, Quality Technology & Development, Biogen

1:30 Utilizing Next-Generation Sequencing and Rapid Molecular Methods to Advance Viral Detection in the Biopharmaceutical Industry

Cassandra Braxton, Ph.D., Scientist II, Quality Technology & Development, Biogen

Viral safety is a critical aspect of ensuring the safety of biological products in the biopharmaceutical industry. Biogen is exploring next-generation sequencing 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 current practices for adventitious virus detection and technologies we are driving towards implementing in the future.

2:00 Reference Materials for Adventitious Virus Detection by Metagenomics

Edward Mee, Ph.D., Senior Scientist, Live Viral Vaccines, Virology, National Institute for Biological Standards and Control

High throughput sequencing offers great potential for improved adventitious virus screening, however several practical challenges exist, including cost, complexity and the difficulty in defining limits of detection for unknown viruses. Well-characterized reference materials containing representative virus genome, capsid and envelope structures will enable meaningful inter-laboratory comparisons, support method development and act as process run controls.

3:30 End of Conference