Measurement of Residual Host Cell Protein and DNA.docVIP

Measurement of Residual Host Cell Protein and DNA in Biotechnology Products Workshop June 3–4, 2013 USP Headquarters, Rockville, Maryland ~ Draft Agenda ~ (As of May 3, 2013) Monday, June 3, 2013 (Day 1) 7:30 a.m. Registration/Information and Continental Breakfast 8:30 a.m. Opening and Welcome: Roger Williams, M.D., USP 8:45 a.m. Workshop Overview: Laureen Little, Ph.D., BEBPA 9:00 a.m.–12:45 p.m. Session I: Regulatory Considerations and Platform Approaches for Measurement of Residual Host Cell Proteins Chair(s): Anthony Mire-Sluis, Ph.D., USP General Chapters Biological Analysis Expert Committee Vice-Chairman 9:00 a.m. Process-related Impurities and their Impact on Product Quality- A Regulatory Perspective Barbara Rellahan, Ph.D., U.S. Food and Drug Administration (FDA) 9:25 a.m. Common Approaches to Host Cell Protein Measurement in Europe Joerg Englebergs, Ph.D., Paul Ehrlich Institute, Germany 9:50 a.m. Flexible Platform HCP ELISAs: Building and Characterizing a Multi-Product, Multi-Process Toolkit Heather Boux, Ph.D., Amgen Inc. 10:15 a.m. QC Use of Kit and Specific HCP Assays through the Drug Development Pathway Sian Estdale, Ph.D., Covance, United Kingdom 10:40 a.m. Break 11:10 a.m. The Devil in the Detail: HCP Assay Performance by Design Olaf Stamm, Ph.D., Charles River Biopharmaceutical Services, Germany 11:35 a.m. Studying Host Cell Protein and Antibody Interactions Using Protein A Affinity Chromatography Kathlyn Lazzareschi, Ph.D., Genentech 12:00 p.m. Isolation of Representative CHO related Protein (CHOP) for mAb Process Challenge Studies Tom Gleason, Amgen Inc. 12:25 p.m. Questions and Answers for Session 1 Speakers 12:45 p.m. Lunch Monday, June 3, 2013 (continued…) 1:45–5:30 p.m. Session II: Host Cell Protein Assay and Reagent Qualification Issues Chair(s): Wes Workman, Ph.D., USP General Chapters Biological Analysis Chairman 1:45 p.m. A Case Study: One particular CHOP co-purifying with Monoc