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- Published online July 18, 2016.
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- previous version (April 18, 2016 - 18:05).
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© PDA, Inc. 2016
Author Information
- Serge Mathonet1,*,
- Hanns-Christian Mahler2,
- Stefan T. Esswein3,
- Maryam Mazaheri4,
- Patricia W. Cash4,
- Klaus Wuchner5,
- Georg Kallmeyer6,
- Tapan K. Das7,
- Christof Finkler8 and
- Andrew Lennard9
- 1Global Regulatory Affairs—Biologics CMC, Sanofi R&D, 91385 Chilly-Mazarin, France;
- 2Drug Product Services, Lonza AG, 4002 Basel, Switzerland;
- 3NBE Analytical R&D, Abbvie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany;
- 4Analytical Biotechnology, MedImmune, Gaithersburg, MD;
- 5PDMS Analytical Development, Janssen R&D, 8205 Schaffhausen, Switzerland;
- 6Quality Combination Products, Roche, 68305 Mannheim, Germany;
- 7Biologics Development, Bristol Myers Squibb, Hopewell, NJ;
- 8Analytical Development & Quality Control, Pharma Technical Development Biologics EU, Roche, 4002 Basel, Switzerland; and
- 9Regional Regulatory Affairs CMC, Amgen Ltd, Uxbridge, UK
- ↵* Corresponding Author: e-mail: Serge.Mathonet@sanofi.com; telephone: +33 6 73 23 26 85.
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- Article
- Abstract
- 1. Problem Statement
- 2. Visual Inspection at End of Drug Product Manufacturing—100% Inspection Followed by Sampling Inspection
- 3. QC Sample Testing
- 4. Control of Visible Particles in Lyophilized Products
- 5. Particle Identification and Characterization
- 6. Patient Safety
- 7. Conclusions
- Conflict of Interest Declaration
- Acknowledgments
- Appendix 1: Inspector Certification
- Appendix 2: Risk Assessment of Visible Particles
- References
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