Company: Thermo Fisher Scientific
Liaison(s): Peter Bell, Elena Ingerman
Thermo Fisher Scientific is a multinational biotechnology company, which provides analytical instruments, specialty diagnostics, life science solutions, and laboratory products to the scientific and healthcare community. While maintaining their philosophy of a healthier, cleaner and safer world, Thermo Fisher Scientific helps their customers accelerate life sciences research through novel analytical tools and reagents. The company’s end markets include Diagnostic & Healthcare, Pharma & Biotech, Academic & Government, and Industrial & Applied, with 60% of their recurring revenue coming from consumables and 27% derived from instruments, equipment, and software.
CAR-T therapies are novel personalized therapies, which have demonstrated remarkable effectiveness in recent clinical trials against late stage hematological cancers. As a result, several CAR-T therapies have received FDA approval and there is a consensus that CAR-T therapies will represent a growing strategy to attack late stage hematological cancers – and perhaps even solid tumors. CAR-T therapies represent an emerging type of personalized therapy with unique requirements for patient cell expansion, production and testing. Consequently, these new therapies will require novel analytical tools and reagents to produce consistent high-quality FDA approvable therapies.
During the first semester, the Thermo Fisher TMP team developed a detailed understanding of all aspects of the CAR-T manufacturing process. The team’s goal was to identify the critical quality attributes (CQAs) important for analytical assays used throughout CAR-T cell manufacturing. During the second semester, the Thermo Fisher TMP Team conducted numerous voice of customer (VOC) interviews and surveys with commercial CAR-T manufacturers, regulatory bodies, and academics. Ultimately, the Thermo Fisher TMP Team produced a detailed report for Thermo Fisher Scientific, which identified growing analytical and reagent market opportunities in the CAR-T therapeutic marketplace.