Advanced Therapy Medicinal Products (ATMPs) are a class of biological medicines defined under EU Regulation 1394/2007, encompassing gene therapy products, somatic cell therapy products, and tissue-engineered products. ATMPs represent some of the most complex and innovative treatments in modern medicine, including CAR-T cell therapies, stem cell transplants, and gene-corrected cell products.
Categories of ATMPs
Gene Therapy Products contain recombinant nucleic acid sequences intended to regulate, repair, or replace a gene sequence. Cell Therapy Products contain cells that have been manipulated or are intended to perform a pharmacological, immunological, or metabolic action. Tissue-Engineered Products contain cells or tissues that have been engineered to regenerate, repair, or replace human tissue.
Regulatory Requirements for ATMPs in the EU
ATMPs are regulated by the EMA’s Committee for Advanced Therapies (CAT) and require centralized marketing authorization. Manufacturing must comply with EU GMP Annex 2A for ATMPs, with specific requirements for raw material qualification, traceability, and contamination control.
Serum and Media Considerations for ATMP Manufacturing
For GMP ATMP manufacturing, animal-derived components such as FBS must be qualified and ideally replaced with human-derived or recombinant alternatives (e.g., HPL, recombinant albumin) to reduce xenogeneic risk and regulatory burden.
English 
Deutsch