ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics

The revisions to ICH Q2 and Q14 provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products. The updates address the specific challenges and complexities of biologics, such as the need for specific analytical techniques and understanding critical quality attributes. The revisions offer guidance to manufacturers and regulators on the appropriate analytical methods for biologics.

This article discusses advancements in targeted medicines, it also provide insights and information on targeted medicines.

The existing guidance on analytical development for biological products is expanded upon in the revisions, providing more detailed information and examples for techniques such as mass spectrometry and qPCR. The guidance emphasizes the importance of selecting suitable analytical methods to support the development of biological medicines and addresses uncertainty and deviation from standard approaches. It also discusses challenges and risks associated with potency assays and product impurity assays in Phase III and biologics license applications. The guidance clarifies areas of ambiguity from regulatory authorities, such as the use of robustness testing in validation protocols. Overall, the new guidance aims to improve the analytical development process for biological products and ensure compliance with regulatory requirements.