A–Mab: A Case Study in Bioprocess Development
| dc.contributor.author | Phillips, Joseph | |
| dc.contributor.author | Ericson, Lisa | |
| dc.contributor.author | Karunatilake, Chulani | |
| dc.contributor.author | Schenerman, Mark | |
| dc.contributor.author | et al | |
| dc.date.accessioned | 2024-05-08T19:22:21Z | |
| dc.date.available | 2024-05-08T19:22:21Z | |
| dc.date.issued | 2009-10-30 | |
| dc.description | "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 " | |
| dc.description.abstract | 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. | |
| dc.description.uri | https://ispe.org/publications/guidance-documents/a-mab-case-study-in-bioprocess-development | |
| dc.format.extent | 278 pages | |
| dc.genre | reports | |
| dc.identifier | doi:10.13016/m2xtzh-csie | |
| dc.identifier.citation | CMC 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-development | |
| dc.identifier.uri | http://hdl.handle.net/11603/33670 | |
| dc.language.iso | en_US | |
| dc.publisher | ISPE | |
| dc.relation.isAvailableAt | The University of Maryland, Baltimore County (UMBC) | |
| dc.relation.ispartof | UMBC Biotechnology at Shady Grove | |
| dc.rights | This 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. | |
| dc.rights | CC0 1.0 Universal | en |
| dc.rights.uri | http://creativecommons.org/publicdomain/zero/1.0/ | |
| dc.title | A–Mab: A Case Study in Bioprocess Development | |
| dc.type | Text |