A leading cell and gene therapy CDMO located in Cambridge, MA desired to qualify and implement platform shipping systems that could maintain their product requirements and regulatory compliance.
Challenges
- Aggressive timeline to complete qualification and provide shipping services to clients
- Cost conscience project budget
- Three separate temperature ranges required +2 to +8C, -15 to -25C, < -65C
- Variety of product container sizes and material of construction
- Required secondary packaging design/optimization
Lean Biologix Strategy
- Reviewed CDMO product offerings and specifications, packaging materials and distribution information
- Thermal mass assessment of product offerings to determine payload bracket required for min/max batch size
- Material of Construction assessment to determine worst case for packaging robustness evaluation
- Identified shipping system vendor and completed scorecard
- Developed qualification strategy for thermal / transportation simulation studies and real time shipping studies
- Managed all GDP/GMP documentation to facilitate project milestones
- Optimized shipping system through custom payload box to meet all product offerings
- Managed all operational and performance (real time) testing efforts
- Supported supplier onboarding, training and implementation
Summary of Engagement
Lean Biologix lead qualification efforts and provided on time delivery of milestones. They collaborated with manufacturer and testing facilities to perform shipping qualification in accordance with industry standards and trends. Three shipping systems and three temperature applications for each shipping system +2 to +8C, -15 to -25C, < -65C were qualified. The shipping solutions were implemented and used at CDMO facilities. CDMO can support any client product shipment with confidence.