Characterization of a biological product, which includes the determination of physicochemical and immunochemical properties, biological activity, purity and related substances/impurities, is necessary to establish the safety and efficacy profile of a given product.
Biological activity describes the specific ability, or capacity, of a product to achieve a defined biological effect. Determination of biological activity is a key requirement for biopharmaceutical products, both for lot release as well as ongoing stability programs. The development and qualification/validation of cell based potency assays is critical for measuring biological activity and ensuring consistent product quality. Due to the complex nature of biological assays, managing outsourced cell based potency assay projects can be challenging.
This presentation will provide an overview of cell based potency assays, including current regulatory expectations as well as trends within the industry. In addition, the presentation will offer perspectives, from both a sponsor as well as a contract testing laboratory, with regard to the logistics of outsourcing cell based potency assays and will provide recommendations aimed to help biopharmaceutical companies effectively manage their outsourced programs.
Topics will include:
- Current regulatory expectations for cell based potency assays
- Phase appropriate qualification/validation strategies
- Life cycle management of cell based potency assays
- Points to consider when working with contract testing laboratories
Weihong Wang, Ph.D., manager of Molecular and Cell Biology Services, Eurofins Lancaster Laboratories
Dr. Weihong Wang is manager of Molecular and Cell Biology Services for Lancaster Laboratories where she oversees assay development/validation projects, as well as routine sample testing. She serves as a subject matter expert and direct technical contact to assist clients with testing needs and conducts QA/QC investigations to ensure successful fulfillment of business and quality metrics.
Dr. Wang has 11 years of experience developing and characterizing biopharmaceutical products and developed extensive experience with cell and ELISA based potency assays through her previous positions at Wyeth Biopharma (currently part of Pfizer) and Johnson and Johnson Companies. Dr. Wang also participates in USP/FDA task forces, and along with her senior staff, actively monitors emergent technologies in the industry, as well as changes in regulatory expectations.
Dr. Wang earned a Ph.D. in Cell and Molecular Biology from Brandeis University and completed postdoctoral research at Harvard Medical School.
Darren Kamikura, Ph.D., Research Scientist, Eli Lilly and Co
Dr. Kamikura has been developing cell based assays in the bioassay group at Lilly since 2009. Prior to joining Lilly he was at XactaGen in Seattle, WA where he studied the application of various reporters, including ß-Galactosidase and luciferases to monitor gene regulation in cell-based assays.
Dr. Kamikura obtained bachelor’s degree from the University of British Columbia (Vancouver, Canada; 1993) in Biochemistry and Molecular Biology. He obtained his doctoral degree in Molecular Oncology at McGill University (Montreal, Canada; Ph.D. 1999) and trained as a post-doctoral fellow at the Fred Hutchinson Cancer Research Center, in Seattle, WA.
Who Should Attend?
This program is intended for scientists, managers and directors working in bioanalytical method development and quality control, for manufacturers of:
- Monoclonal Antibodies
- Recombinant Proteins
- Antibody drug conjugates
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℠.