GMP Production
In September 2019, we opened our cGMP compliant manufacturing facility for the clinical production of our iPSC-derived cell product candidates. Our cGMP facility, located in San Diego, California, is custom designed for the manufacture of off-the-shelf cell product candidates using clonal master iPSC lines as the starting cell source. The new state-of-the-art facility has been commissioned and qualified, and we are licensed to manufacture cell therapies by the State of California, Department of Health Services, Food and Drug Branch.
The manufacture of our off-the-shelf, iPSC-derived cellular immunotherapy product candidates involves a three-stage process:
- The first stage involves generating a clonal master iPSC line and generally consists of the following steps: (i) obtain appropriately-consented healthy human donor cells; (ii) induction of pluripotency in the donor cells using a proprietary transgene integration-free and footprint-free method of reprogramming; (iii) genetic engineering of iPSCs; and (iv) isolation and selection of a single iPSC to produce a clonal master iPSC line.
- The second stage is intended to derive the cell product population of interest and generally consists of the following steps: (i) expansion and differentiation of the clonal master iPSC line to produce CD34+ cells; and (ii) further expansion and differentiation of these cells to produce the cell product population of interest.
- The third stage is intended to derive the final cell product and generally consists of the following steps: (i) formulating the cell product population; and (ii) cryopreserving individual aliquots of the final cell product and storing these aliquots in single-dose infusion bags.
In January 2020, we entered into a new lease agreement for our future headquarters facility, a 200,000-square-foot life sciences complex in San Diego, CA that is designed to include a 40,000 square foot cGMP cell manufacturing facility.
