Not all cGMP transfection reagents are made equal
Current Good Manufacturing Practice (cGMP) guidelines are set by regulatory agencies to reduce risks in the production of pharmaceuticals and medical devices by ensuring the purity, safety and efficacy of the products. In the United States, pharmaceutical companies are legally required to adhere to cGMP standards set by the US Food and Drug Administration (FDA; MD, USA). However, the FDA takes a different approach in defining cGMP guidelines for pharmaceuticals versus medical devices.
This article explores these regulations and introduces key considerations for selecting transfection reagents. It also addresses questions such as, “What are the differences between cGMP regulations for pharmaceutical and medical devices?” “How does this relate to transfection reagents?” and “What cGMP guidelines are my transfection reagents compliant with?”
