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Design-for-Six-Sigma for Development of a Bioprocess Quality-by-Design Framework.

Beth Junker1, Mike Kosinski, David Geer

  • 1Bioprocess Development, Vaccines Research and Pre-Clinical Development, Biologics Manufacturing Sciences & Commercialization, Global Vaccines Technology and Engineering/Global Biologics Quality, Merck and Co, Inc.

PDA Journal of Pharmaceutical Science and Technology
|February 2, 2012
PubMed
Summary
This summary is machine-generated.

A new Quality-by-Design (QbD) framework was developed for biopharmaceutical development using Design-for-Six-Sigma (DFSS). This efficient approach prioritizes patient needs and ensures robust product development with minimized resources.

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Area of Science:

  • Biopharmaceutical Development
  • Process Engineering
  • Quality Management Systems

Background:

  • Quality-by-Design (QbD) is essential for robust biopharmaceutical development, focusing on patient needs and product quality attributes.
  • Current development practices require efficient frameworks that integrate product, process, and analytical aspects.

Purpose of the Study:

  • To develop and implement an initial Quality-by-Design (QbD) framework for biopharmaceutical product, process, and analytical development.
  • To leverage the Design-for-Six-Sigma (DFSS) methodology for an efficient and streamlined QbD framework development.

Main Methods:

  • Utilized the Design-for-Six-Sigma (DFSS) methodology, emphasizing voice-of-the-customer and efficient resource allocation.
  • Assembled a bioprocess QbD framework comprising seven teams, based on six QbD elements and a communication/training team.
  • Evaluated framework elements against best practices, charter, and design inputs, identifying gaps and mitigating risks.

Main Results:

  • A streamlined and efficient QbD framework was developed, minimizing resource requirements.
  • The framework design incorporated patient requirements and translated them into actionable quality attributes and control strategies.
  • Existing governance and IT were leveraged to minimize additional bioprocess resources.

Conclusions:

  • The developed QbD framework provides a robust approach for biopharmaceutical development, ensuring consistent product quality.
  • The DFSS methodology facilitated an efficient QbD framework assembly, suitable for current organizational and regulatory needs.
  • Selected metrics will track the success of pilot programs and full implementation of the QbD framework.