Operational Milestone #1
We are developing a new stem cell transplant product, AB-110, to treat blood cancers, such as lymphoma and leukemia. AB-110 is composed of human umbilical cord blood derived hematopoietic stem and progenitor cells co cultured and expanded with Angiocrine’s proprietary E-CEL UVEC cells. The early studies demonstrating the feasibility of this approach in animal models used product derived from small scale cell co-culture in tissue culture flasks. To manufacture the product at a scale suitable for treating patients, we devised a process that uses a closed system bioreactor that can rapidly produce sufficient material with minimal human intervention. This process is both economical and reliable. Our objective in the past quarter was to optimize this manufacturing process and to demonstrate, both in cell culture assays and in animal models, that the product generated in the bioreactor is comparable to the product generated in tissue culture flasks. To optimize the process, we systematically explored the many variables in the system and ultimately succeeded in demonstrating that we could reproducibly expand umbiliical cord stem and progenitor cells over 300-fold in twelve days. We then succeeded in demonstrating that cells derived from the two processes are indistinguishable in their cellular composition, their content of stem and progenitor cells as measured in colony forming assays, and their ability to restore the immune system of irradiated mice. With this milestone achieved, AB-110 is now poised to move into highly regulated manufacturing of clinical grade material.