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Process characterization and Design Space definition.

Christian Hakemeyer1, Nathan McKnight2, Rick St John2

  • 1Pharma Technical Development, Roche Diagnostics GmbH, Sandhofer Str. 116, 68305 Mannheim, Germany.

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Summary
This summary is machine-generated.

Quality by Design (QbD) enhances pharmaceutical development by proactively designing manufacturing processes. This approach uses risk assessments and statistical studies to define critical process parameters for recombinant monoclonal antibody production.

Keywords:
Design spaceMonoclonal antibodyProcess characterizationProcess validationQuality by design (QbD)

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Area of Science:

  • Pharmaceutical Manufacturing
  • Biotechnology
  • Regulatory Science

Background:

  • Quality by Design (QbD) is a regulatory initiative to improve pharmaceutical development.
  • ICH guidelines (ICHQ8-11) outline QbD principles for product development.
  • Understanding product and process knowledge is crucial for manufacturing.

Purpose of the Study:

  • To describe tools for characterizing and validating MAb manufacturing under QbD.
  • To identify potential Critical Process Parameters (pCPPs) using risk assessments.
  • To establish an overview of product and process knowledge for MAb production.

Main Methods:

  • Integrated risk assessments to identify pCPPs.
  • Statistically designed experimental studies.
  • Studies assessing unit operation linkages.

Main Results:

  • Classification of process parameters by criticality.
  • Definition of acceptable operating ranges.
  • Gained process and product knowledge enabling Design Space approval.

Conclusions:

  • QbD facilitates proactive pharmaceutical manufacturing process design.
  • Risk assessments and experimental studies are key to QbD implementation.
  • Defined process parameters and ranges ensure consistent product quality and inform testing strategies.