Commercial Strategy: Supporting Global Car-T Biotech Company to Commercialize their Technology in Partnership with Leading Pharmaceutical Company and CMOs

Situation

• Small global biotechnology company had developed proprietary technologies which use particles, antibodies, and media for cell separation
• The company was about to sign an agreement with a large, leading pharmaceutical company to apply these technologies in one of their research projects (immunology) requiring them to manage a tech transfer of their technologies to a set of CMOs, and set up a GMP manufacturing process, approved by the FDA, for use in human cells

Solution

• Brought in external capability and capacity to manage and coordinate all ongoing partnership activities between the two partner companies
• Developed work plans with milestones and ensured execution of day-to-day activities with regular progress update on project, KPIs to leadership team
• Performed CRO/CMO site audits and amended quality plans to establish proper GMP manufacturing and quality processes

Impact

• Successfully managed the transfer of key technologies to selected CMOs within defined milestones and targets
• Ensured launch readiness and GMPS qualification, identified and implemented CMO partners to scale up production