Points to Consider No. 13: Materials in ATMP Manufacturing provides comprehensive advice on managing raw materials in the production of advanced therapy medicinal products (ATMPs), aiming to support stakeholders in developing robust material control strategies and promoting best practices across the industry.
BETHESDA, Md., Sept. 18, 2025 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) has announced the release of its latest technical document, Points to Consider No. 13: Materials in ATMP Manufacturing. This comprehensive report provides critical guidance for managing raw materials in the production of advanced therapy medicinal products (ATMPs), aiming to support stakeholders in developing robust material control strategies and promoting best practices across the industry.
ATMPs pose unique challenges compared to traditional pharmaceuticals with their raw materials come from nontraditional sources, such as animals and humans. They typically are not covered in national pharmacopeias nor manufactured for GMP applications. Additionally, the majority are produced by single-sourced small, specialized suppliers.
"Points to Consider No. 13: Materials in ATMP Manufacturing is a great resource to support the industry's growing focus on ATMP / cell- and gene-therapies. PDA is grateful to the authoring team for their time and commitment to produce this document. Special thanks go to the leadership of the Co-Chairs Friedrich von Wintzingerode, PhD of Roche-Genentech and Marc Glogovsky of ValSource, Inc. for guiding the team and effort to success."
The new PDA document applies to all raw materials that interact with the ATMP manufacturing process stream, including:
- Starting and ancillary materials
- Excipients
- Consumables
- Container–closure systems
It addresses both clinical and commercial manufacturing stages across a range of ATMP modalities, including:
- Cell-free mRNA therapeutics
- Viral vector–based in vivo gene therapies
- Human cells for autologous or allogeneic cell therapies
- Tissue-engineered medicinal products
About PDA
The Parenteral Drug Association (PDA) is a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA's mission is to advance pharmaceutical and biopharmaceutical science and regulation so members can better serve patients.
Media Contact
Walter Morris, www.pda.org, 1 3016565900, [email protected], www.pda.org
SOURCE www.pda.org
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