Product Quality in the Advanced Therapies Manufacturing

In the highly regulated Advanced Therapies (ATMP) industry, success hinges on a company’s ability to innovate rapidly while maintaining high product quality. This requires a collaborative effort from regulatory experts, manufacturers, and stakeholders to ensure that drugs meet stringent safety and efficacy standards from development through commercialization.

This white paper explores how product quality is defined by both consumer expectations and regulatory requirements, highlighting the complementary perspectives of the FDA and the International Council for Harmonization (ICH). Its author, Joseph Bibeault, Director of RA-CMC at ReciBioPharm, delves into the critical role of Chemistry, Manufacturing, and Controls (CMC) in ensuring that all aspects of drug production—from raw material synthesis to final product stability—adhere to these rigorous standards.

Readers will learn about the pivotal role of Regulatory Affairs CMC (RA-CMC) professionals, who manage the complex process of maintaining regulatory compliance across a drug’s lifecycle. This includes addressing challenges such as manufacturing changes and ensuring consistent product supply across global markets.

The article underscores the importance of building quality into every stage of drug development, emphasizing that a forward-thinking approach to regulation and innovation is essential for success in the pharmaceutical industry. 
 

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