Phillips, JosephEricson, LisaKarunatilake, ChulaniSchenerman, Market al2024-05-082024-05-082009-10-30CMC Work Group Consortium. "A–Mab: A Case Study in Bioprocess Development". ISPE (October 2009). https://ispe.org/publications/guidance-documents/a-mab-case-study-in-bioprocess-developmenthttp://hdl.handle.net/11603/33670"Authors:- Amgen Team: Joseph Phillips (Lead), Lisa Ericson, Chulani Karunatilake, Bob Kuhn, and Anurag Rathore Abbott Team: Ed Lundell (Lead), Hans-Juergen Krause, Christine Rinn, Michael Siedler, Sonja Simon, Carsten Weber, Brian Withers Eli Lilly Team: Victor Vinci (Lead), Michael DeFelippis, John R. Dobbins, Matthew Hilton, Bruce Meiklejohn, and Guillermo Miroquesada Genentech Team: Lynne Krummen (Co-Lead), Ron Taticek (Co-Lead), Sherry Martin-Moe, and Brian Kelley GSK Team: Ilse Blumentals (Lead), John Erickson, Alan Gardner, Dave Paolella, Premthesh S. Patel, Joseph Rinella, Mary Stawicki, Greg Stockdale MedImmune Team: Mark Schenerman (Lead), Gail Wasserman , Cindy Oliver, Kripa Ram, Laurie Kelliher, David Robbins, Jen Anderson, Sanjeev Ahuja, Nancy Craighead, Andy Niedzielski, and Orit Scharf. Pfizer Team: Leslie Bloom (Lead), Amit Banerjee, Carol Kirchhoff, Wendy Lambert, and Satish Singh "This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and Q10 guidelines could be applied to product realisation programs for a biotechnology-derived monoclonal antibody.278 pagesen-USThis item is likely protected under Title 17 of the U.S. Copyright Law. Unless on a Creative Commons license, for uses protected by Copyright Law, contact the copyright holder or the author.CC0 1.0 UniversalText