Ancillary Material Regulatory Digest For ATMPs

Transfection reagents are critical raw materials for gene therapy product manufacturing. They fall under the denomination of ancillary Materials (AMs), a subset of raw materials. AMs can influence the therapeutic agent but are not intended to be present in the final Advanced Therapy Medicinal Products (ATMP) product.

During the development of a gene therapy, patient safety will always be a top priority, and regulators may inquire about how the risk of employing AMs in the manufacturing process has been minimized. To prevent having to move to different AMs due to regulator feedback, it’s worth carefully assessing the eligibility of an AM before as early as possible before entering clinical testing as it will result in a significant gain of time and money.