Published: November 2021
Advanced Therapy Medicinal Product (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.
There are two general primary focus areas for ATMPs:
This Guide acknowledges that the term ATMP is quite broad and that these are emerging therapies utilizing rapidly evolving technology and equipment. In recognition of this, this Guide focuses on autologous cell therapies while providing content that may be applicable to other types of ATMPs.
This Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.
For the full list of contributors to this Guide see Guidance Document Teams