A global biotechnology company working toward regulatory approval of a gene therapy treatment was required to perform shipping validation to support review and approval in the US market.

Internal stakeholders needed to tightly manage the timeline required for qualification activities to support the regulatory submission targets.

Lean Biologix was requested to support the team to qualify the following material types:

  • Master Cell Banks and Working Cell Banks (cryovials, LN2)
  • Plasmids and Plasmid Cell Banks (cryovials, biotainers, Dry Ice)
  • Drug Substance (flexible bag/bioshell, Dry Ice)
  • Bulk DP (crystal zenith vials, Dry Ice)
  • Finished Good (multi count vial box, ancillary components, Dry Ice)

Summary of Engagement

Lean Biologix Process:

  • Assembled team of SMEs to support various material type qualifications
  • Streamlined qualification process to perform multiple material types in parallel
  • Used bracketing approach to satisfy thermal load across multiple material types without repeat testing
  • Used bracketing approach to determine worst case test payload for transportation simulation across multiple material types
  • Supported design team to develop and qualify state-of-the-art custom dry ice shipping system for bulk drug product and finished good distribution
  • Production Deployment
      • Rigid outer container, payload immobilizer, onboard temperature and distribution hazards (vibration, shock etc.) monitoring with GPS communication to cloud based tracking platform