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Best Practices for Analytical Procedure Development and Validation under ICH Q2(R2) and Q14
Driving Analytical Excellence: Implementing ICH Q2(R2) and Q14 in Biologics
In today's evolving regulatory landscape, the development and validation of analytical procedures for biologics demand a structured, science-driven approach. Ulrike Herbrand (Scientific Director of Global In Vitro Bioassays and Head of Bioassay R&D at Charles River Laboratories) is a key contributor within a team of authors selected by BioPhorum to present a guide that translates the ICH Q2(R2) and Q14 guidelines into best practices for the biopharmaceutical industry.
This guide emphasizes a Quality by Design (QbD) framework to improve the consistency, reliability, and regulatory readiness of analytical procedures. A key focus is the Analytical Target Profile (ATP), a definition of what the procedure needs to measure, and how it will perform. The ATP serves as the foundation for technology selection, helping to ensure alignment with critical quality attributes (CQAs) and providing a flexible framework as products progress through development.
The document also outlines a practical, risk-based approach to technology selection, using scoring matrices that consider both ATP requirements and business drivers such as ease of transfer, scalability, and lifecycle compatibility. Special attention is given to platform technologies and procedures, which leverage prior knowledge to streamline development and validation.
Validation, under ICH Q2(R2), is reframed as a continuation of development rather than a separate stage. The guide provides clear direction on robustness studies, equipment qualification, phase-appropriate validation, and the value of linking development data to validation efforts to demonstrate method performance and fitness for use.
To support lifecycle thinking, the paper introduces the concept of an Analytical Procedure Lifecycle Management (APLCM) document. This centralized documentation approach supports regulatory submissions and ongoing procedural updates, offering flexibility for post-approval changes and simplifying regulatory interactions.
This cross-industry effort, featuring contributions from experts at Charles River, provides critical insights into practical implementation of these new guidelines. Ulrike Herbrand's contributions lend particular depth to sections on method lifecycle and bioassay validation.