What is ATMP (Advanced Therapy Medicinal Product)?

ATMP manufacturing requirements

ATMP manufacturing under GMP requires: full traceability of all starting and raw materials; adventitious agent testing (mycoplasma, sterility, viral safety); validated processes with defined critical quality attributes (CQAs); and qualified person (QP) release. Raw materials including FBS, human serum, and albumin require full documentation — species certification, TSE/BSE statements, donor screening, viral testing. EMA strongly encourages replacement of animal-derived raw materials with human-derived (xeno-free) or recombinant (ACF) alternatives.

SeamlessBio products for ATMP manufacturing

hPL (xeno-free for MSC, T cell, NK expansion), rHSA (ACF albumin), OsrhTF (ACF transferrin), FBS Low Endotoxin (when FBS required), human AB serum HI (PBMC and immune cell work). All supplied with full regulatory documentation packages.

Key Facts

• Three ATMP categories: Gene Therapy Medicinal Products (GTMP), Somatic Cell Therapy Medicinal Products (sCTMP), Tissue-Engineered Products (TEP)
• GTMP examples: AAV-based gene replacement (Luxturna, Zolgensma), lentiviral gene correction, in vivo CRISPR therapy
• sCTMP examples: CAR-T cells (Kymriah, Yescarta), NK cell therapies, MSC-based immunomodulation
• TEP examples: engineered cartilage, skin equivalents, corneal reconstructions
• EMA Committee for Advanced Therapies (CAT) provides scientific recommendations for ATMP classification and approval
• Manufacturing: GMP Annex 2 and Annex 16 apply; xeno-free and ideally ACF raw materials strongly preferred
• Hospital Exemption (HE): EU member states may allow non-routine ATMPs under hospital exemption without full marketing authorisation

Further Reading

• What is Xeno-Free Cell Culture?
• What is Animal Component-Free?
• What is hPL?
• iPSC & Stem Cell Culture Guide

SeamlessBio GmbH · Passau, Germany · info@seamlessbio.de