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Related Experiment Video

Updated: May 22, 2025

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Analytical control strategy for biologics. Part I: Foundations.

Brent S Kendrick1, Krishnan Sampathkumar2, John P Gabrielson3

  • 1First Principles Biopharma, LLC, Louisville, CO, USA.

Journal of Pharmaceutical Sciences
|May 12, 2025
PubMed
Summary
This summary is machine-generated.

This commentary outlines the foundational elements for developing a robust analytical control strategy for biologic therapeutics. It emphasizes an integrated approach to ensure product quality and efficient lifecycle management for protein-based drugs.

Keywords:
Analytical method developmentAnalytical method validationAnalytical target profileBiologicsControl strategyFormulation robustnessMethod qualificationMonoclonal antibodiesQBDQuality target product profile

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Area of Science:

  • Biopharmaceutical Development
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Biologic therapeutics, despite diverse molecular profiles, share a common pharmaceutical development pathway.
  • This pathway integrates a control strategy involving target product profiles (TPP), quality target product profiles (QTPP), characterization, critical quality attributes (CQAs), and analytical control.
  • Existing guidance addresses specific development studies but lacks comprehensive direction on establishing analytical control strategies within integrated frameworks.

Purpose of the Study:

  • To present the essential foundations for developing a comprehensive analytical control strategy for biologic therapeutics.
  • To provide a framework for efficient lifecycle management of protein-based therapeutic modalities.
  • To serve as Part I of a two-part series, laying the groundwork for subsequent implementation roadmaps.

Main Methods:

  • Review and synthesis of existing regulatory guidance (ICH, FDA, EMA) for biologic development.
  • Analysis of the components of an integrated control strategy for biologics.
  • Identification of foundational elements crucial for establishing an analytical control strategy.

Main Results:

  • The development of biologic therapeutics necessitates an integrated control strategy.
  • Key components include TPP, QTPP, extensive characterization, CQA identification, and an analytical control strategy.
  • Foundational principles for analytical control strategy development are essential for lifecycle management.

Conclusions:

  • Establishing a comprehensive analytical control strategy is critical for the successful development and lifecycle management of biologic therapeutics.
  • This commentary provides the foundational knowledge for creating such strategies.
  • Part II will detail a stage-appropriate roadmap for implementing the analytical control strategy.