Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products

Life Sciences, Pharmaceutical, Pharma Manufacturing & Supply Chain,
  • Wednesday, March 21, 2012

A key requirement for production of biopharmaceutical products is to ensure freedom from contamination by adventitious agents, including bacteria, fungi, mycoplasma and viruses. In addition to compromising product safety, contamination events can be devastating to the manufacturer from the perspectives of lost product, lost production time and the time and expense of cleaning a contaminated facility.

Contamination from these agents can arise in a number of different ways, such as through the use of contaminated raw materials or contamination from personnel. Some contaminants cause obvious effects and are therefore easily detected. However, other agents do not cause obvious changes in the production process and are more difficult to detect.

This presentation will address current strategies for evaluating and mitigating the risk of contamination by adventitious agents. Topics discussed will include the following:

  • Control and testing of raw materials
  • Testing of cell substrates and process intermediates
  • Protecting the purification process
  • Assay capabilities and limitations

Implementation of risk mitigation strategies for adventitious contamination can increase the timeline for production significantly, but new assays are being developed that provide answers more rapidly than the well-accepted testing methodologies. The role of these new assays in a risk-mitigation program will be addressed.

The presentation will conclude with a case study describing steps implemented in a manufacturing process to mitigate the risk of adventitious contamination.


Jeri Ann Boose, Ph.D., director, Biopharmaceutical Services, Lancaster Laboratories

Dr. Jeri Ann Boose is director of Biopharmaceutical Services for Lancaster Laboratories. In this position, Dr. Boose provides strategic, scien­tific and regulatory direction for the company’s biopharmaceutical testing business, which includes extensive capabilities in biochemistry, cell and molecular biology and virology.

Dr. Boose has expertise in the formulation of global regulatory product testing strategies and in the preparation of global regulatory filings at all stages of product development. Her specialties include knowledge of cGMP require­ments, expectations and practices; assay and process validation; viral/TSE/microbial clearance validation; cell line characterization; raw materials testing; lot release testing; cleaning validation; and analytical and stability testing.

Dr. Boose earned a Ph.D. from Georgetown University. She has published numerous papers in the field and has held positions in academics, government and industry.

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Katherine Bergmann, Ph.D., manager, Viral Safety and Viral Clearance Services, Lancaster Laboratories

Dr. Katherine Bergmann is manager of Viral Safety and Viral Clearance Services at Lancaster Laboratories. She has extensive experience in cell line characterization, lot release testing and viral/TSE clearance validation and has numerous publications and presentations in the field. She has performed biomedical research in protein chemistry, cell biology and virology at Georgetown University, Scripps Research Institute and Rockefeller University.

Dr. Bergmann received a Ph.D. from Brown University and a A.B. degree from Mount Holyoke College. Dr. Bergmann served on the PDA task force on Preparation of Virus Spikes Used for Virus Clearance Studies.

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Yuling Li, Ph.D., fellow, BioPharmaceutical Development, MedImmune

Dr. Yuling Li is currently a Fellow (Scientific Director) in Process Biochemistry- BioPharmaceutical Development at MedImmune (Gaithersburg, MD) where she is responsible for providing input on scientific/technical directions and strategies for the company process development activities. She is currently leading an integrated viral safety team across the organization to mitigate the risk associated with adventitious agents and also directing other cross-functional technical initiatives. Prior to joining MedImmune, Dr. Li was the Senior Director of Purification Sciences-BioPharmaceutical Development at Human Genome Sciences Inc. (HGS, Rockville, MD). Since joining HGS in 1994, she had held positions of increasing responsibility and oversaw the company’s recombinant protein and antibody purification process development activities. She has contributed to bringing more than a dozen of biopharmaceuticals, including monoclonal antibodies, recombinant protein therapeutics, and one small molecule drug to various stages of clinical development, including a key role in the development and preparation for commercialization of BENLYSTA™ (belimumab) for lupus and ABthrax for inhalation anthrax. Before joining HGS, Dr. Li was at Hoffmann-La Roche Inc. in Nutley, New Jersey, where she conducted process research and development on PEGylated Interferon-alpha.

Dr. Li received her Ph.D. from Robert Wood Johnson Medical School at UMDNJ. During the course of her career, she published 30+ peer-review articles and is the primary inventor for seven issued patents. She has spoken at many international biopharmaceutical conferences. She was a member of industry experts in taskforce groups working with the FDA, EMEA and USP to address issues and guidelines associated with biopharmaceutical development.

Dr. Li is the former President (2007-2008) of the Chinese Biopharmaceutical Association-USA (CBA, http://www.cba-usa.org/), a non-profit professional organization. Dr. Li also co-founded the Alliance of Chinese-American Biotechnology and Pharmaceutical Associations (ALL-CABPA) in 2008.

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Who Should Attend?

This program is intended for scientists, managers and directors working in cell banking, cell culture process development, quality assurance/quality control, viral clearance and raw material testing for manufacturers of:

  • Vaccines
  • Monoclonal Antibodies
  • Recombinant Proteins
  • Tissue Engineered Products
  • Cellular Therapeutics
  • Blood-derived products

Xtalks Partner

Lancaster Laboratories

With a proven track record of providing quality scientific solutions for 19 of the top 20 largest pharmaceutical/biopharmaceutical companies in the world, Lancaster Laboratories is a global leader in bio/pharmaceutical laboratory services providing innovative and timely scientific solutions to streamline the drug development process.

With facilities in Lancaster, PA, Portage, MI and Dungarvan, County Waterford, Ireland, and a global capacity of over 300,000 square feet, Lancaster Laboratories has the capabilities to meet your global regulatory requirements. All of our facilities offer cGMP-compliant laboratory services and operate under the same strict quality control program and utilize the same LIMS system.

Our clients can choose from five service models, including our award-winning Professional Scientific Staffing℠ and our Full Time Equivalent model to determine the most efficient and cost-effective service solution for their project. We also provide 24-hour data access via our innovative and secure online tool at LabAccess.com℠.

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