Parenteral Drug Association (PDA) · Published November 2025
Points to Consider No. 14: Manufacturing of ATMPs – Facility Design (Part 1)
Juergen Metzger contributed as an author to this PDA Points to Consider document on facility, utility, process-equipment and risk-management considerations for the manufacture and testing of advanced therapy medicinal products (ATMPs).
Publication details
Contributing author: Juergen Metzger (listed affiliation: Sartorius)
Publisher: Parenteral Drug Association (PDA)
Published: November 2025
ISBN: 978-1-945584-51-0
Pages: 62
PDA item number: 43596
Document scope
The PDA publication considers the facility, utilities and process-equipment designs needed to support the manufacture and testing of autologous and allogeneic ATMP therapies. It emphasizes evaluating these design considerations early so that the manufacturing process can meet its applicable requirements.
The document is organized around practical questions. Each question presents an overall recommendation, supported where appropriate by its rationale and references for further reading.
Topics addressed
- Risk management
- Facilities
- Utilities
- Process equipment
- Supplementary technical information and recommended reading
Together, these topics support a structured review of how the manufacturing environment, supporting systems and production equipment should be considered as an integrated ATMP facility concept.
Relevance to advanced manufacturing
ATMP operations must align the process, facility, utilities, material and personnel flows, contamination-control measures and equipment strategy. Early design decisions can therefore affect operational robustness, flexibility and the ability to control risks throughout the facility lifecycle.
Metzger's contribution to this multi-author PDA document complements his broader technical work in aseptic processing, barrier technology, equipment concepts and advanced fill-finish manufacturing.
Related PTC expertise
Pharma-Technology-Consulting provides independent advisory support for aseptic fill-finish strategy, isolators and RABS, Annex 1 implementation, contamination-control concepts, equipment and vendor selection, automation and pharmaceutical CAPEX project alignment.
Related technical background is available in Aseptic Fill-Finish Consulting, Barrier Systems & Isolators and Aseptic Processes.