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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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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
  • PDF

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Cited By...

  • Definition of Particle Visibility Threshold in Parenteral Drug Products--Towards Standardization of Visual Inspection Operator Qualification
  • Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations
  • Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
  • Characterization of a Novel Particle in a Pharmaceutical Drug Product
  • Development and Qualification of Visible Particle Load Analysis Methods for Injectable Drug Product Primary Packaging Components
  • Micro-Flow Imaging: Estimation of the Contribution of Key Factors to the Variability of Subvisible Particle Count Measurement by a Nested Statistical Analysis
  • Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
  • Achieving "Zero" Defects for Visible Particles in Injectables
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Keywords

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

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