Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.

Autor: Zamiri C; Pharmaceutical Development, Genentech (A Member of the Roche group), South San Francisco, CA 94080; zamiri.camellia@gene.com danielle.leiske@abcellera.com., Leiske DL; Product Quality Management, Seagen, Bothell, WA 98021; zamiri.camellia@gene.com danielle.leiske@abcellera.com., Hughes P; Office of Pharmaceutical Manufacturing Assessment, Office of Product Quality, FDA/CDER, Silver Spring, MD 20993., Kirwan JP; Global Regulatory Affairs and Strategy, CMC, Amgen, Thousand Oaks, CA 91320., Der E; PTQP Analytical Sciences Chapter, Genentech (A Member of the Roche group), South San Francisco, CA 94080., Cox E; BioPharmaceuticals Development, R&D, Dosage Form Design and Development, AstraZeneca, Gaithersburg, MD, 20878., Warburton R; Bioproduct Research & Development, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285., Goss M; Drug Product Technologies, Amgen, Thousand Oaks, CA 91320., Weiser S; BTx PharmSci, Pharmaceutical Research and Development, Pfizer, Andover, MA 01810., Perez-Brown J; Microbiology Center of Excellence, BMS, New Brunswick, NJ 08903., Gopalrathnam G; Bioproduct Pharma Design, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285., Liu J; Pharmaceutical Sciences, Seagen, Bothell, WA 98021., Mehta SB; Drug Product Development and Operations, CMC Biologics, Teva Branded Pharmaceutical Products, West Chester, PA 19380., Shereefa S; Regulatory Affairs CMC, AbbVie, North Chicago, IL 60064., Specht S; Regulatory Affairs, CMC, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland., Aedo SJ; BioTherapeutics Drug Product Development Janssen, Pharmaceutical Companies of Johnson & Johnson, Janssen Research and Development, Malvern, PA 19355., Goldbach P; Pharmaceutical Development & Supplies, Pharma Technical Development, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland., Jia F; Biologics Drug Product, Biogen, Cambridge, MA 02142., Kuehnle B; Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, 88397 Biberach /Riss, Germany., Page S; Regulatory Affairs CMC, AbbVie, North Chicago, IL 60064., Voeten L; Analytical Development, Microbiology Center of Excellence Janssen, Pharmaceutical Companies of Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium., Yi L; Formulation Development, AbbVie, South San Francisco, CA 94080; and., Zhu C; Biologics Drug Product Development and Manufacturing, Sanofi, Framingham, MA, 01701.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2024 Aug 23; Vol. 78 (4), pp. 475-500. Date of Electronic Publication: 2024 Aug 23.