Using Analytical Platform Technologies to Support Accelerated Product Development-Concept Review and Case Study

Area of Science:

• Biopharmaceutical development
• Analytical chemistry
• Regulatory science

Background:

• Increasing number of biological products for serious conditions eligible for expedited development programs.
• Need for efficient strategies to support accelerated drug development timelines.

Purpose of the Study:

• To present an industry perspective on reducing analytical life cycle steps using analytical platform technologies (APT).
• To support accelerated biological product development and associated Chemistry, Manufacturing, and Control (CMC) processes.

Main Methods:

• Conceptual review of life cycle strategies for APT methods within the CMC acceleration framework.
• Detailed case study illustrating initial method validation and subsequent APT verification.
• Discussion of APT implementation considerations.

Main Results:

• Reduced method qualification, transfer, and validation studies are feasible if the initial test method remains unchanged.
• A case study demonstrates practical considerations for APT validation and verification.
• Guidance on submitting APT information in regulatory filings is provided.

Conclusions:

• APT offers a viable strategy to reduce analytical life cycle burdens in accelerated biological product development.
• Careful initial method validation and subsequent verification are key to successful APT implementation.
• Streamlined analytical processes using APT can expedite the availability of important therapies.