PDA is developing a Points to Consider document focusing on production and engineering controls for the production of ATMPs, including multi-product facilities, scale-up or scale-out, and cross-contamination control from the engineering site, including overall control strategies.
Volunteers with manufacturing, QC, engineering, HVAC, biosafety, or other related skills and experience wishing to join the authoring team are encouraged to submit their qualifications for consideration.
Participants will need to attend regular conference calls and commit to providing input and subject matter for the Points to Consider Document.
- Process Engineering
- ATMP/Gene and Cell Therapy