Lonza won a roughly $9.5 million National Institutes of Health Center for Regenerative Medicine (NIH CRM) contract for the cGMP manufacture of induced pluripotent stem cells (iPSCs) and clinical-grade iPSC-derived cell types. In August Lonza negotiated a global license to the iPSC stem cell technologies invented by Kyoto University’s Shinya Yamanaka, Ph.D., whose team first converted adult human cells to an embryonic stem cell-like state in 2007. Dr. Yamanaka and John B. Gurdon, Ph.D., have jointly been awarded the 2012 Nobel Prize for Physiology or Medicine for their respective work on cell reprogramming.
The NIH CRM contract takes the form of a five-year indefinite delivery/indefinite quantity award. This format of U.S. government contract provides for an indefinite quantity of services for a fixed time period. Minimum and maximum quantity limits are, however, specified either in terms of ‘volume’, or value of services.
“Our goal is to help cell therapy developers navigate the complexities of process optimization and cGMP-compliant manufacturing for clinical trials and beyond,” comments Lukas Utiger, president of the Lonza Walkersville operation, which is the recipient of the contract. “Being awarded this contract further validates Lonza’s position as the partner of choice for moving iPSC technology into the clinic.”
Lonza’s Pluripotent Stem Cell Innovation Center is focused on both technology development and the provision of stem cell services. The center’s development projects encompass technologies in cell reprogramming, cell culture systems, and differentiation, for applications in basic research and potentially commercial stem cell therapies. Lonza says researchers can now access its expertise, capacity, and capabilities in pluripotent stem cell research and applications to cGMP manufacturing through its PSC service offering spanning from iPSC generation to process development and differentiation.