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Article CommentaryCommentary

A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products

Serge Mathonet, Hanns-Christian Mahler, Stefan T. Esswein, Maryam Mazaheri, Patricia W. Cash, Klaus Wuchner, Georg Kallmeyer, Tapan K. Das, Christof Finkler and Andrew Lennard
PDA Journal of Pharmaceutical Science and Technology July 2016, 70 (4) 392-408; DOI: https://doi.org/10.5731/pdajpst.2015.006189
Serge Mathonet
1Global Regulatory Affairs—Biologics CMC, Sanofi R&D, 91385 Chilly-Mazarin, France;
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  • For correspondence: Serge.Mathonet@sanofi.com
Hanns-Christian Mahler
2Drug Product Services, Lonza AG, 4002 Basel, Switzerland;
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Stefan T. Esswein
3NBE Analytical R&D, Abbvie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany;
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Maryam Mazaheri
4Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Patricia W. Cash
4Analytical Biotechnology, MedImmune, Gaithersburg, MD;
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Klaus Wuchner
5PDMS Analytical Development, Janssen R&D, 8205 Schaffhausen, Switzerland;
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Georg Kallmeyer
6Quality Combination Products, Roche, 68305 Mannheim, Germany;
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Tapan K. Das
7Biologics Development, Bristol Myers Squibb, Hopewell, NJ;
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Christof Finkler
8Analytical Development & Quality Control, Pharma Technical Development Biologics EU, Roche, 4002 Basel, Switzerland; and
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Andrew Lennard
9Regional Regulatory Affairs CMC, Amgen Ltd, Uxbridge, UK
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Article Information

vol. 70 no. 4 392-408
DOI 
https://doi.org/10.5731/pdajpst.2015.006189
PubMed 
27091885

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online July 18, 2016.

Article Versions

  • previous version (April 18, 2016 - 18:05).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2016

Author Information

  1. Serge Mathonet1,*,
  2. Hanns-Christian Mahler2,
  3. Stefan T. Esswein3,
  4. Maryam Mazaheri4,
  5. Patricia W. Cash4,
  6. Klaus Wuchner5,
  7. Georg Kallmeyer6,
  8. Tapan K. Das7,
  9. Christof Finkler8 and
  10. Andrew Lennard9
  1. 1Global Regulatory Affairs—Biologics CMC, Sanofi R&D, 91385 Chilly-Mazarin, France;
  2. 2Drug Product Services, Lonza AG, 4002 Basel, Switzerland;
  3. 3NBE Analytical R&D, Abbvie Deutschland GmbH & Co. KG, 67061 Ludwigshafen, Germany;
  4. 4Analytical Biotechnology, MedImmune, Gaithersburg, MD;
  5. 5PDMS Analytical Development, Janssen R&D, 8205 Schaffhausen, Switzerland;
  6. 6Quality Combination Products, Roche, 68305 Mannheim, Germany;
  7. 7Biologics Development, Bristol Myers Squibb, Hopewell, NJ;
  8. 8Analytical Development & Quality Control, Pharma Technical Development Biologics EU, Roche, 4002 Basel, Switzerland; and
  9. 9Regional Regulatory Affairs CMC, Amgen Ltd, Uxbridge, UK
  1. ↵* Corresponding Author: e-mail: Serge.Mathonet{at}sanofi.com; telephone: +33 6 73 23 26 85.
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PDA Journal of Pharmaceutical Science and Technology: 70 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 70, Issue 4
July/August 2016
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A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
Serge Mathonet, Hanns-Christian Mahler, Stefan T. Esswein, Maryam Mazaheri, Patricia W. Cash, Klaus Wuchner, Georg Kallmeyer, Tapan K. Das, Christof Finkler, Andrew Lennard
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 392-408; DOI: 10.5731/pdajpst.2015.006189

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A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
Serge Mathonet, Hanns-Christian Mahler, Stefan T. Esswein, Maryam Mazaheri, Patricia W. Cash, Klaus Wuchner, Georg Kallmeyer, Tapan K. Das, Christof Finkler, Andrew Lennard
PDA Journal of Pharmaceutical Science and Technology Jul 2016, 70 (4) 392-408; DOI: 10.5731/pdajpst.2015.006189
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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
  • Figures & Data
  • References
  • Info & Metrics
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Keywords

  • 100% inspection
  • Lyophilized
  • Quality control sampling
  • QC sampling
  • Particle identification
  • proteinaceous particles
  • Visible particles

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