New guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products (ATMP) have been adopted by the European Commission.
ATMPs are medicinal products for human use based on genes or cells that offer potentially ground-breaking opportunities for the treatment of injury and disease, particularly in cases of severe, untreatable or chronic diseases which do not respond adequately to conventional treatments.
After thorough consulting with stakeholders, the European Medicines Agency (EMA) and competent national authorities, the updated guidelines adapt the GMP requirements to the specifics of ATMPs and address unique scenarios such as reconstitution of ATMPs, decentralised manufacturing and automated production.
As a result of the guidelines adopting a risk-based approach, manufactures have some flexibility in their processes and control systems, depending on the level of risk. Furthermore, the guidelines explain the traceability data that ATMP manufacturers should keep for 30 years in line with Article 15 of ATMP Regulation (EC/1394/2007).
Unique challenges may be faced during the manufacturing of ATMPs, for example, limited availability and intrinsic variability of the starting materials, very small batch sizes and short shelf-lives. However, the updated guidelines introduced in the GMP framework for ATMPs ensure a high level of quality for ATMPs and a high degree of patient protection.
It is expected that the new guidelines will provide increasing opportunities for patients to be enrolled in clinical trials with ATMPs in the EU and will have a significant input in the development of ATMPs.