Advanced Therapy Medicinal Products (ATMPs) represent a novel class of complex biological products that are at the forefront of scientific innovation and hold great potential to improve health care. To ensure that appropriate measures are put in place by the manufacturers to safeguard the quality of the product, all ATMPs produced for human use from clinical Phase I onward must comply with current Good Manufacturing Practice (cGMP) regulations.¹

cGMP requirements can be very complex and guidance on how to interpret the minimum expected standards specific to ATMPs are laid down in EudraLex Volume 4 – Part IV “Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products”.

As ATMPs are administered to the human body as an injectable medicine, these are required to be sterile. Hence, the manufacture of these products requires specific focus and requirements to minimise the risk of microbiological contamination. Considering the level of complexity in the often-manual manufacturing process and the complex manipulation steps involved, aseptic manufacturing is paramount.