Integrating Analytical Method Development And Quality Control

By Michael Sousa, Eli Kraus, Manish Tandon

The development of cell and gene therapies presents unique challenges due to the complexity of these products and the evolving regulatory landscape. Analytical methods are essential for assessing critical quality attributes such as identity, potency, purity, and safety. However, many of these methods originate in research settings and must be refined to meet clinical and commercial standards under Good Manufacturing Practices (GMP). Effective Analytical Method Development (AMD) and Quality Control (QC) integration is crucial to ensuring seamless method transfer, minimizing variability, and maintaining compliance with regulatory expectations. Without this alignment, therapies face significant risks, including inconsistent analytical results, costly rework, and regulatory setbacks that can delay time to market.

By integrating AMD and QC, drug developers can streamline processes, improve method robustness, and ensure regulatory readiness from early development through commercialization. This approach fosters real-time collaboration, allowing for proactive risk mitigation and a smoother transition from non-GMP to GMP testing environments. It also enhances data integrity, traceability, and adaptability to emerging technologies, ensuring that advanced therapies meet the highest standards for quality and safety. A case study from Landmark Bio demonstrates how an aligned AMD-QC strategy supports efficient method transfer, preserves expertise throughout the product lifecycle, and reduces resource redundancies. As cell and gene therapies continue to advance, a well-integrated analytical framework will be critical for accelerating development timelines, optimizing regulatory submissions, and ultimately delivering transformative treatments to patients more efficiently.