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Review ArticleReview

PCMO L01—Setting Specifications for Biological Investigational Medicinal Products

Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology September 2015, 69 (5) 569-589; DOI: https://doi.org/10.5731/pdajpst.2015.01065
Stephan O. Krause
AstraZeneca Biologics, 633 Research Court, Frederick, MD 21703, USA; 301-398-2108;
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  • For correspondence: krauses@medimmune.com
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References

  1. 1.↵
    ICH Guidance for Industry Q8(R2): Pharmaceutical Development.
  2. 2.↵
    ICH Guidance for Industry Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities).
  3. 3.↵
    ICH Guidance for Industry Q9: Quality Risk Management.
  4. 4.↵
    ICH Guidance for Industry Q10: Pharmaceutical Quality System.
  5. 5.↵
    ICH Guidance for Industry Q6B: Specifications: Test Procedures and Acceptance Criteria.
  6. 6.↵
    A-Mab: A Case Study in Bioprocess Development, CASSS- ISPE.
  7. 7.↵
    EBE: Concept Paper, Considerations in Setting Specifications, 28 March 2013.
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    1. Allen P. V.
    Determination of release limits: ageneral methodology. Pharm. Res. 1991, 8(9), 1210–1213.
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    Using a Risk Assessment Process to Determine Criticality of Product Quality Attributes. In Quality by Design for Biopharmaceuticals: Perspectives and Case Studies; Rathore A. S., Mhatre R., Eds.; Wiley Interscience: Hoboken, NJ, 2009;pp 53–84.
  11. 11.↵
    1. Krause S.
    , WCBP Meeting, 30 Jan 2013, Washington, DC.
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    , CaSSS CMC Strategy Forum, 27 Jan 2014, Washington, DC.
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    PDA Technical Report 57. Analytical Method Validation and Transfer for Biotechnology Products, 2012.
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    1. Krause S
    . Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies; PDA/DHI Publication: Bethesda, MD, 2007.
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    EMA, Report of the Expert Workshop on Setting Specifications for Biotech Products, London, 09 September 2011.
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    Ph. Eur. Monograph on Monoclonal Antibodies for Human Use, 2013.
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    . WHO expert committee on biological standardization—highlights of the meeting of October 1996. Biologicals 1997, 25(3), 359–362.
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    USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests.
  19. 19.↵
    USP <85> Bacterial Endotoxins Test.
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    EP 2.9.19 Particulate Contamination: Sub-visible Particles and USP <788> Particulate Matter in Injections.
  21. 21.↵
    USP <1> Injections.
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    EP 2.9.17. Test for Extractable Volume of Parenteral Preparations.
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    Accelerated product development: leveraging industry and regulator knowledge to bring products to patients quickly. Bioprocess Intl., 11 December 2014.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 5
September/October 2015
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PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 569-589; DOI: 10.5731/pdajpst.2015.01065

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PCMO L01—Setting Specifications for Biological Investigational Medicinal Products
Stephan O. Krause
PDA Journal of Pharmaceutical Science and Technology Sep 2015, 69 (5) 569-589; DOI: 10.5731/pdajpst.2015.01065
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  • Article
    • Abstract
    • 1. Introduction and Scope
    • Abbreviations
    • 2. Control Strategy
    • 3. Setting and Justification of Specifications During Product Development
    • 4. Typical DS and DP Specification Revision and Justification Examples
    • 5. Case Study for Product Imp Specification Setting Process
    • 6. Discussion
    • Including Statistical Uncertainty
    • Conflict of Interest Declaration
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