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Best Practices for Microbial Challenge In–use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Camellia Zamiri, Danielle L. Leiske, Patricia F. Hughes, J. Paul Kirwan, Evelyn Der, Emily Cox, Rob Warburton, Monica Goss, Sarah Weiser, Janet Perez-Brown, Ganapathy Gopalrathnam, Jing Liu, Shyam B. Mehta, Shebeer Shereefa, Sebastian Specht, Sandra J. Aedo, Pierre Goldbach, Feng Jia, Barbara Kuehnle, Scott Page, Liesbeth Voeten, Li Yi and Chen Zhu
PDA Journal of Pharmaceutical Science and Technology October 2023, pdajpst.2022.012806; DOI: https://doi.org/10.5731/pdajpst.2022.012806
Camellia Zamiri
1 Pharmaceutical Development, Genentech (A Member of the Roche group), 1 DNA Way, South San Francisco, CA 94080, USA;
Danielle L. Leiske
2 Product Quality Management, Seagen, 21717 30th Drive S.E. Bothell, WA 98021, USA;
Patricia F. Hughes
3 Office of Pharmaceutical Manufacturing Assessment, Office of Product Quality FDA/CDER, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA;
J. Paul Kirwan
4 Global Regulatory Affairs and Strategy, CMC, Amgen, One Amgen Center Dr, Thousand Oaks, CA 91320, USA;
Evelyn Der
5 PTQP Analytical Sciences Chapter, Genentech (A Member of the Roche group), 1 DNA Way, South San Francisco, CA 94080, USA;
Emily Cox
6 BioPharmaceuticals Development, R&D, Dosage Form Design and Development, AstraZeneca, 1 Medimmune Way, Gaithersburg, MD, 20878, USA;
Rob Warburton
7 Bioproduct Research & Development, Eli Lilly & Company, Lilly Research Laboratories Eli Lilly and Company, Indianapolis, IN 46285, USA;
Monica Goss
8 Drug Product Technologies, Amgen, One Amgen Center Dr, Thousand Oaks, CA 91320, USA;
Sarah Weiser
9 BTx PharmSci, Pharmaceutical Research and Development, Pfizer; 1 Burtt Rd, Andover, MA 01810, USA;
Janet Perez-Brown
10 Microbiology Center of Excellence, BMS, One Squibb Drive New Brunswick, NJ 08903, USA;
Ganapathy Gopalrathnam
11 Bioproduct Pharma Design, Eli Lilly & Company, Lilly Research Laboratories, Eli Lilly and Company Indianapolis, IN 46285 USA;
Jing Liu
12 Pharmaceutical Sciences, Seagen, 21717 30th Drive S.E. Bothell, WA 98021, USA;
Shyam B. Mehta
13 Drug Product Development and Operations, CMC Biologics Teva Branded Pharmaceutical Products, 145 Brandywine Pkwy, West Chester, PA 19380 USA;
Shebeer Shereefa
14 Regulatory Affairs CMC, AbbVie,1 N Waukegan Rd, North Chicago, IL 60064, USA;
Sebastian Specht
15 Regulatory Affairs, CMC, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
Sandra J. Aedo
16 BioTherapeutics Drug Product Development Janssen, Pharmaceutical Companies of Johnson & Johnson, Janssen Research and Development, Malvern, PA 19355, USA;
Pierre Goldbach
17 Pharmaceutical Development & Supplies, Pharma Technical Development, Roche, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland;
Feng Jia
18 Biologics Drug Product, Biogen, 225 Binney Street, Cambridge, MA 02142, USA;
Barbara Kuehnle
19 Pharmaceutical Development, BI, Boehringer Ingelheim Pharma GmbH & Co. KG;
Scott Page
14 Regulatory Affairs CMC, AbbVie,1 N Waukegan Rd, North Chicago, IL 60064, USA;
Liesbeth Voeten
20 Analytical Development, Microbiology Center of Excellence Janssen, Pharmaceutical Companies of Johnson & Johnson, Turnhoutseweg 30, 2340 Beerse, Belgium;
Li Yi
21 Formulation Development, AbbVie, 1000 Gateway Blvd, South San Francisco, CA 94080, USA;
Chen Zhu
22 Biologics Drug Product Development and Manufacturing, Sanofi, One the Mountain Road, Framingham, MA, 01701, USA
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 1
January/February 2025
Best Practices for Microbial Challenge In–use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Camellia Zamiri, Danielle L. Leiske, Patricia F. Hughes, J. Paul Kirwan, Evelyn Der, Emily Cox, Rob Warburton, Monica Goss, Sarah Weiser, Janet Perez-Brown, Ganapathy Gopalrathnam, Jing Liu, Shyam B. Mehta, Shebeer Shereefa, Sebastian Specht, Sandra J. Aedo, Pierre Goldbach, Feng Jia, Barbara Kuehnle, Scott Page, Liesbeth Voeten, Li Yi, Chen Zhu
PDA Journal of Pharmaceutical Science and Technology Oct 2023, pdajpst.2022.012806; DOI: 10.5731/pdajpst.2022.012806
Best Practices for Microbial Challenge In–use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Camellia Zamiri, Danielle L. Leiske, Patricia F. Hughes, J. Paul Kirwan, Evelyn Der, Emily Cox, Rob Warburton, Monica Goss, Sarah Weiser, Janet Perez-Brown, Ganapathy Gopalrathnam, Jing Liu, Shyam B. Mehta, Shebeer Shereefa, Sebastian Specht, Sandra J. Aedo, Pierre Goldbach, Feng Jia, Barbara Kuehnle, Scott Page, Liesbeth Voeten, Li Yi, Chen Zhu
PDA Journal of Pharmaceutical Science and Technology Oct 2023, pdajpst.2022.012806; DOI: 10.5731/pdajpst.2022.012806
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