Five Ways To Overcome The Challenges Of Designing A Quality Control Program For New Modalities

By Audrey Chang, Ph.D., Executive Director, CMC Scientific Advisor, WuXi Advanced Therapies

In the tightly regulated world of biologic manufacturing, quality control (QC) release testing plays a critical role, including ensuring that each batch meets GMP standards through scientifically-backed data and established specifications. While global regulations may vary slightly by country, all authorities require a deep dive into the following aspects of a biologic product: identity, purity, potency, safety, and critical quality attributes.

Modern biologic manufacturing utilizes a three-pronged testing approach: characterization, batch release, and purification. Thorough characterization of all starting materials, including the cell bank and raw components, is a crucial first step. Each production batch should undergo a comprehensive panel of QC assays at designated checkpoints throughout the process. Downstream purification processes are rigorously evaluated for their ability to eliminate or inactivate potential viral contaminants. Data generated from these three testing categories, often referred to as the biosafety testing triangle, has significantly contributed to the exceptional safety record established for biologics. To learn more about how to adapt analytical panels to better accommodate complex CGTs, download the full article.