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Peer-Reviewed Publication
PDA J Pharm Sci Technol2024;78(4):475-500.August 23, 2024Journal Article

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

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, Chen Zhu22
1Pharmaceutical Development, Genentech (A Member of the Roche group), South San Francisco, CA 94080; zamiri.camellia@gene.com danielle.leiske@abcellera.com.
2Product Quality Management, Seagen, Bothell, WA 98021; zamiri.camellia@gene.com danielle.leiske@abcellera.com.
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.
PubMed DOI

Abstract

Microbial challenge in-use studies are performed to evaluate the potential for microbial proliferation in preservative-free single-dose biological products after first puncture and potential accidental contamination during dose preparation (e.g., reconstitution or dilution) and storage. These studies, in addition to physicochemical in-use stability assessments, are used as part of product registra…

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