Ancillary material regulatory digest for ATMPs
Transfection reagents are critical raw materials for gene therapy product manufacturing, falling into the category of ancillary materials, a subset of raw materials. Ancillary materials can influence the therapeutic agent but are not intended to be present in the final therapeutic product.
Points to remember for ancillary materials of gene therapy products are:
- Chemical-based transfection reagents, cell culture media, process enzymes are examples of ancillary materials utilized in the manufacturing process
- The quality of ancillary materials can affect the final Advanced Therapy Medicinal Product safety, potency and purity
- It is vital to qualify ancillary materials used in the manufacture of gene therapy products
Download the regulatory package and explore regulations for the use of ancillary materials across different regions like the United States, Japan and Europe.
Download the regulatory package
