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Risk-Based Approach for Analytical Comparability and Comparability Protocols.

Kavita Ramalingam Iyer1, Isabelle Lequeux2

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|April 17, 2020
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Postapproval changes in pharmaceutical manufacturing require comparability studies to ensure biologic product quality, safety, and efficacy are maintained. Analytical comparability supports regulatory review for essential similarity.

Keywords:
BiologicsComparabilityEssentially similarICH GuidelinesPostapproval changesRisk-based evaluation of change

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Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Regulatory Science

Background:

  • Chemistry, manufacturing, and control (CMC) postapproval changes are integral to pharmaceutical product lifecycles.
  • Ensuring product quality, safety, and efficacy during these changes is critical for biologics.
  • Existing frameworks may require further elucidation for comprehensive assessment of CMC changes.

Purpose of the Study:

  • To examine the impact of CMC postapproval changes on biologic product quality, safety, and efficacy.
  • To introduce analytical comparability as a key tool for biomanufacturers and regulatory agencies.
  • To detail a holistic approach to comparability studies, integrating risk-based reviews and acceptance criteria.

Main Methods:

  • Review of CMC postapproval change impacts on biologics.
  • Introduction and explanation of analytical comparability studies.
  • Application of International Council for Harmonisation (ICH) guidelines and principles.
  • Presentation of two case studies involving manufacturing facility and process changes.

Main Results:

  • Analytical comparability studies are essential for maintaining product integrity post-change.
  • A scientific, risk-based review approach, coupled with defined acceptance criteria, ensures products remain 'essentially similar'.
  • Case studies illustrate the practical application of comparability principles in real-world manufacturing changes.

Conclusions:

  • Holistic comparability studies, incorporating analytical methods and risk assessment, are vital for managing CMC postapproval changes.
  • These studies provide a robust framework for regulatory agencies and biomanufacturers to ensure patient safety and product efficacy.
  • Adherence to ICH guidelines facilitates consistent and scientifically sound comparability assessments.