Our HuCNS-SC® human neural stem cells are manufactured by qualified personnel working in a clean room production environment, according to current Good Manufacturing Practices (cGMP). Our HuCNS-SC cell banks are purified and expanded in culture prior to cryopreservation. These cell banks remain stable for many years and are used for the onward production of our final product — the HuCNS-SC cells that will be transplanted into patients. Our Quality System approach is designed to ensure that controls are implemented and completed satisfactorily during all manufacturing operations, and that developed procedures and specifications are appropriate and followed, including those performed by contract testing laboratories.
A single “bank” of stem cells derived from an original tissue source can supply a multitude of human doses, depending on the dose used in the indication. We have been manufacturing our HuCNS-SC cells for clinical trials since 2006, and currently have enough cells banked and cryopreserved to fulfill the needs of our Phase II clinical trials in SCI and AMD. We are prepared to scale our processes as needed to meet the requirements of future clinical trials and commercialization.
Stem Cells in a Bottle
Expandable and bankable, HuCNS-SC cells can ultimately be “manufactured” at commercial-scale as “stem cells in a bottle,” then distributed for patient doses, much like an off-the-shelf pharmaceutical product for on-demand use.