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- Published online August 23, 2024.
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Author Information
- Camellia Zamiri1,*,
- Danielle L. Leiske2,*,
- Patricia Hughes3,
- J. Paul Kirwan4,
- Evelyn Der5,
- Emily Cox6,
- Rob Warburton7,
- Monica Goss8,
- Sarah Weiser9,
- Janet Perez-Brown10,
- Ganapathy Gopalrathnam11,
- Jing Liu12,
- Shyam B. Mehta13,
- Shebeer Shereefa14,
- Sebastian Specht15,
- Sandra J. Aedo16,
- Pierre Goldbach17,
- Feng Jia18,
- Barbara Kuehnle19,
- Scott Page14,
- Liesbeth Voeten20,
- Li Yi21 and
- Chen Zhu22
- 1Pharmaceutical Development, Genentech (A Member of the Roche group), South San Francisco, CA 94080;
- 2Product Quality Management, Seagen, Bothell, WA 98021;
- 3Office of Pharmaceutical Manufacturing Assessment, Office of Product Quality, FDA/CDER, Silver Spring, MD 20993;
- 4Global Regulatory Affairs and Strategy, CMC, Amgen, Thousand Oaks, CA 91320;
- 5PTQP Analytical Sciences Chapter, Genentech (A Member of the Roche group), South San Francisco, CA 94080;
- 6BioPharmaceuticals Development, R&D, Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD, 20878;
- 7Bioproduct Research & Development, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285;
- 8Drug Product Technologies, Amgen, Thousand Oaks, CA 91320;
- 9BTx PharmSci, Pharmaceutical Research and Development, Pfizer, Andover, MA 01810;
- 10Microbiology Center of Excellence, BMS, New Brunswick, NJ 08903;
- 11Bioproduct Pharma Design, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285;
- 12Pharmaceutical Sciences, Seagen, Bothell, WA 98021;
- 13Drug Product Development and Operations, CMC Biologics, Teva Branded Pharmaceutical Products, West Chester, PA 19380;
- 14Regulatory Affairs CMC, AbbVie, North Chicago, IL 60064;
- 15Regulatory Affairs, CMC, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
- 16BioTherapeutics Drug Product Development Janssen, Pharmaceutical Companies of Johnson & Johnson, Janssen Research and Development, Malvern, PA 19355;
- 17Pharmaceutical Development & Supplies, Pharma Technical Development, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
- 18Biologics Drug Product, Biogen, Cambridge, MA 02142;
- 19Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, 88397 Biberach /Riss, Germany;
- 20Analytical Development, Microbiology Center of Excellence Janssen, Pharmaceutical Companies of Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium;
- 21Formulation Development, AbbVie, South San Francisco, CA 94080; and
- 22Biologics Drug Product Development and Manufacturing, Sanofi, Framingham, MA, 01701
- ↵* Co-Corresponding Authors: E-mail: zamiri.camellia{at}gene.com; E-mail: danielle.leiske{at}abcellera.com