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

¹ Pharmaceutical Development, Genentech (A Member of the Roche group), 1 DNA Way, South San Francisco, CA 94080, USA;
² Product Quality Management, Seagen, 21717 30th Drive S.E. Bothell, WA 98021, USA;
³ Office of Pharmaceutical Manufacturing Assessment, Office of Product Quality FDA/CDER, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA;
⁴ Global Regulatory Affairs and Strategy, CMC, Amgen, One Amgen Center Dr, Thousand Oaks, CA 91320, USA;
⁵ PTQP Analytical Sciences Chapter, Genentech (A Member of the Roche group), 1 DNA Way, South San Francisco, CA 94080, USA;
⁶ BioPharmaceuticals Development, R&D, Dosage Form Design and Development, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA;
⁷ Bioproduct Research & Development, Eli Lilly & Company, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285, USA;
⁸ Drug Product Technologies, Amgen, One Amgen Center Dr, Thousand Oaks, CA 91320, USA;
⁹ BTx PharmSci, Pharmaceutical Research and Development, Pfizer; 1 Burtt Rd, Andover, MA 01810, USA;
¹⁰ Microbiology Center of Excellence, BMS, One Squibb Drive New Brunswick, NJ 08903, USA;
¹¹ Bioproduct Pharma Design, Eli Lilly & Company, Lilly Research Laboratories, Eli Lilly and Company Indianapolis, IN 46285 USA;
¹² Pharmaceutical Sciences, Seagen, 21717 30th Drive S.E. Bothell, WA 98021, USA;
¹³ Drug Product Development and Operations, CMC Biologics Teva Branded Pharmaceutical Products, 145 Brandywine Pkwy, West Chester, PA 19380 USA;
¹⁴ Regulatory Affairs CMC, AbbVie,1 N Waukegan Rd, North Chicago, IL 60064, USA;
¹⁵ Regulatory Affairs, CMC, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
¹⁶ BioTherapeutics Drug Product Development Janssen, Pharmaceutical Companies of Johnson & Johnson, Janssen Research and Development, Malvern, PA 19355, USA;
¹⁷ Pharmaceutical Development & Supplies, Pharma Technical Development, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
¹⁸ Biologics Drug Product, Biogen, 225 Binney Street, Cambridge, MA 02142, USA;
¹⁹ Pharmaceutical Development, BI, Boehringer Ingelheim Pharma GmbH & Co. KG;
²⁰ Analytical Development, Microbiology Center of Excellence Janssen, Pharmaceutical Companies of Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium;
²¹ Formulation Development, AbbVie, 1000 Gateway Blvd, South San Francisco, CA 94080, USA;
²² Biologics Drug Product Development and Manufacturing, Sanofi, One the Mountain Road, Framingham, MA, 01701, USA