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

The Packaging Qualification Integration (PQI) project explores whether supplier-generated qualification data can be integrated into pharmaceutical packaging processes under appropriate quality and governance frameworks to reduce redundancy, shorten qualification timelines, and strengthen supply chain collaboration without compromising quality, compliance, or patient safety.
Through industry research, workflow analysis, stakeholder interviews, and the development of an industry opinion paper, the project seeks to assess the feasibility of this approach and stimulate informed discussion on more efficient, collaborative, and sustainable packaging qualification practices across the life sciences and logistics industries.

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

ï„‘

Preliminary Research & Industry Insights

July - September

October

ï„‘

Framework Development & Qualification Mapping

ï„‘

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)

Looking for the
technical paper for
this project?

My cart
Your cart is empty.

Looks like you haven't made a choice yet.