ISPE announced the release of the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs) – Autologous Cell Therapy, a first-of-its-kind guide about the development and design of manufacturing facilities for ATMPs.
ATMP therapies include cells, engineered tissues, or the manipulation of the patient’s genome. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals). ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest.
The term ATMP is broad and these are emerging therapies that utilize rapidly evolving technology and equipment. In recognition of this, the new ISPE Guide: ATMPs – Autologous Cell Therapy focuses on autologous cell therapies while providing content that may be applicable to other types of ATMPs. This is the only Guide of its kind in the industry about ATMP manufacturing facilities development and design.
The growing number of autologous products that are entering the pipeline is evidence to the growth potential of this therapeutic approach. Science has promised this for years; it is now delivering on the promise, and it gives new promise and hope to patients that have rare conditions or diseases. It is a game-changer. The product-process relationship for ATMPs is very different from the traditional cell culture-based approach that most people are familiar with. Because the ATMP space has its roots in the academic/hospital environment in a much smaller scale, the application of GMPs to the overall manufacturing operations is a different challenge.