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Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management

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Quality by Design for Biopharmaceutical Drug Product Development

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 18))

Abstract

Much progress has been made in developing systematic processes for assessment of parameter and attribute criticality, and using this information to justify risk-based control and postapproval lifecycle management strategies that are appropriate to assure the quality of each individual product and process. The pilot program experiences provided the opportunity to focus on key areas where additional understanding and alignment were needed to eventually achieve approval of both a risk-based control strategy as well as design space for a biotech product. The key challenges and resolutions are discussed in this chapter.

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References

  • CMC Biotech Working Group (2009) A-Mab case study. Via CASSS website: http://www.casss.org/associations/9165/files/A-Mab_Case_Study_Version_2-1.pdf. Accessed 16 Feb 2014

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Author information

Authors and Affiliations

  1. Regulatory Affairs Department, Genentech, South San Francisco, CA, USA

    Lynne Krummen

Authors
  1. Lynne Krummen
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Corresponding author

Correspondence to Lynne Krummen .

Editor information

Editors and Affiliations

  1. Parenteral Product and Process Development, Amgen Inc., Thousand Oaks, California, USA

    Feroz Jameel

  2. Bill and Melinda Gates Foundation, Chemistry, Manufacturing and Controls, Seattle, Washington, USA

    Susan Hershenson

  3. Division of Product Quality Research, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Testing and Research and Office of Pharmaceutical Sciences, Silver Spring, Maryland, USA

    Mansoor A. Khan

  4. Enterprise Catalyst Group Inc., Palo Alto, California, USA

    Sheryl Martin-Moe

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Krummen, L. (2015). Regulatory Considerations for Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management. In: Jameel, F., Hershenson, S., Khan, M., Martin-Moe, S. (eds) Quality by Design for Biopharmaceutical Drug Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 18. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-2316-8_28

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