Cell & Gene Therapies
Relevance
Packaging qualification is a critical element of pharmaceutical quality and patient safety, ensuring medicinal products remain protected throughout storage, handling, and distribution. As supply chains become more global and complex, life sciences organisations face growing pressure to accelerate time-to-market, control costs, and improve efficiency while maintaining regulatory compliance. Yet current qualification practices often involve significant duplication of effort, with pharmaceutical companies repeating activities already performed by qualified packaging suppliers, while valuable supplier-generated performance and transport data remains underutilised due to concerns around standardisation, traceability, and regulatory acceptance.
GOAL
Project Objectives
The main objective of this project is to broaden the current knowledge of air transportation of BioPharma and CGT (Cellular Therapy and Gene Therapy) products.
Timeline
June - August
Preliminary Research & Industry Insights
July - September
October
Framework Development & Qualification Mapping
Industry Opinion Paper Publication
PROJECT
SUPPORT AND
COLLABORATION.
- Pharma.Aero Board liaison: Edmonton Airport
- Project lead: Milton De la Paz, DFW (Dallas Fort Worth)
- Project members: Pharma.Aero members and partners participating in the survey
- Project external support: BioNTX (Bio North Texas), GeneTether Therapeutics, Taysha Gene Therapies
- Project manager and expert: Franck Toussaint, BSMA (external consultant)
