Manufacturing

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.

Scalability

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.

StemCells has pioneered innovative manufacturing methodologies in order to supply our therapeutic clinical development programs with HuCNS-SC® human neural stem cells. We are prepared to scale our manufacturing processes for commercialization.

Our Manufacturing Process

HuCNS-SC cells are manufactured through a multi-step process consisting of four stages:

  1. Cell Sorting
  2. Cell Culturing
  3. Cell Banking
  4. Final Product
Photo of Sorting

Cell Sorting

The first production step comprises a proprietary method for purification of HuCNS-SC cells from donated fetal brain tissue procured from an FDA-registered, not-for-profit agency, in compliance with Good Tissue Practice (GTP) and all other applicable state and federal regulations. As part of the purification process, cells from the tissue are “tagged” with a monoclonal antibody that recognizes human neural stem cells. High-speed Fluorescence Activated Cell Sorting (FACS) is then used to isolate the cells tagged by the monoclonal antibody. The FACS-isolated HuCNS-SC cells are then placed in cell culture.

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Photo of Sorting

Cell Culturing

Further purification of the FACS-isolated HuCNS-SC cells is achieved through selective cell culture in a defined, serum-free medium. From one tissue source, we are able to grow billions of cells, which can be used to create cryopreserved cell banks. Extensive testing has shown that the HuCNS-SC cells retain their in vitro and in vivo potential for multi-lineage differentiation to form all three types of central nervous system (CNS) cells — neurons, astrocytes and oligodendrocytes — throughout extended cell culture.

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Cell Banking

HuCNS-SC Master Cell Banks (MCBs) are cyropreserved at an early cell culture stage, and are the source of HuCNS-SC Working Cell Banks (WCBs), which are cryopreserved at later cell culture stages. In compliance with US and International regulatory guidelines, MCBs and WCBs are extensively tested and must meet quality control specifications for attributes of safety, purity, identity and potency in order to be released for use in onward manufacturing. Similar to traditional biotechnology cell culture production, multiple WCBs can be created from a single MCB and many final product doses can be created from each WCB.

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Final Product: “Stem Cells in a Bottle”

HuCNS-SC patient doses are manufactured from a Working Cell Bank (WCB). For release, the final product must once again meet a series of quality control specifications for safety, purity, identity and potency. When test results indicate that the specifications have been met, Quality Assurance releases the final product for distribution and clinical use. Our “stem cells in a bottle” are supplied in sterile vials, as an aseptic suspension of cells for surgical transplantation.

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