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Analytical control strategy for biologics. Part II: Roadmap for development and implementation.

Krishnan Sampathkumar1, Brent S Kendrick2, John P Gabrielson3

  • 1SSK Biosolutions LLC, North Potomac, MD 20878, USA; Currently at Invetx, Inc. by Dechra, Natick, MA 01760, USA.

Journal of Pharmaceutical Sciences
|May 16, 2025
PubMed
Summary
This summary is machine-generated.

This article provides a roadmap for developing analytical control strategies for biologic therapeutics. It details a stage-appropriate approach from pre-clinical development through commercialization for integrated product control.

Keywords:
Analytical method developmentAnalytical method validationBiologicsCMC roadmapControl strategyFormulation robustnessMethod qualificationMonoclonal antibodiesQbDQuality target product profile

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Area of Science:

  • Biopharmaceutical Development
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Biologics therapeutics have diverse molecular profiles, necessitating robust control strategies.
  • Existing guidance focuses on specific studies, lacking a comprehensive analytical control strategy framework.
  • This article is the second part of a series, building upon foundational concepts of analytical control strategy.

Purpose of the Study:

  • To present a streamlined, stage-appropriate roadmap for developing and implementing analytical control strategies for therapeutic biologics.
  • To guide the integration of analytical control strategies throughout the product lifecycle, from pre-clinical to commercialization.
  • To address the gap in specific guidance for comprehensive analytical control strategy development in biologics.

Main Methods:

  • Review and synthesis of existing regulatory guidance (ICH, FDA, EMA) and scientific literature.
  • Development of a lifecycle-aligned roadmap for analytical control strategy implementation.
  • Focus on key elements: Quality Target Product Profile (QTPP), process development, analytical method development, qualification, validation, and verification.

Main Results:

  • A practical roadmap for analytical control strategy development across different biologics modalities.
  • Emphasis on integrating analytical controls from early-stage development to commercial launch.
  • Alignment of technical and regulatory requirements throughout the product lifecycle.

Conclusions:

  • A well-defined analytical control strategy is crucial for the successful development and commercialization of therapeutic biologics.
  • The proposed roadmap facilitates a stage-appropriate and integrated approach to analytical control.
  • Implementing this strategy ensures product quality and regulatory compliance for diverse biologics.