Strategically Design Your Quality Control Toolkit To Better Mitigate Risk

The well-established biosafety testing triangle, which encompasses characterization, batch release, and purification, has been instrumental in maintaining a stellar safety record for traditional biologics. However, as the field ventures into more intricate therapies like cell and gene treatments, robust quality control (QC) programs that can accommodate complexity and unique risks are becoming paramount.

In a recent WuXi Advanced Therapies webinar, Dr. Audrey Chang, Executive Director, highlighted the crucial role of QC release testing in biologics manufacturing. Dr. Chang emphasized the importance of QC to achieve regulatory compliance and deliver safe, high-quality treatments to patients. The webinar addressed challenges associated with developing robust QC programs for cutting-edge biologics, such as AAV vector therapies and CAR-T cell therapies. In an audience Q&A session following the webinar, Dr. Chang explored strategies for designing reliable QC programs, mitigating risk, and collaborating with your peers across the industry. Download the full article to read Dr. Chang's responses.