CDI’s mission is to advance the development of therapeutics for the most devastating human diseases by providing scientists with unparalleled access to biologically relevant human cells for use in drug discovery and cell therapy research.
Unparalleled Scientific Experience
CDI employs more than 80 scientists with unparalleled experience in human stem cell culture and differentiation, genetic engineering, and process science. Using cutting-edge technologies, we have pioneered techniques for developing and manufacturing induced pluripotent stem (iPS) cells and differentiating them into functional human cells.
Our iCell® and MyCell® products, which represent both apparently healthy donors and donors with specific disease genotypes and phenotypes across nine different human cell types, have been manufactured at commercial quantities, cryopreserved, and inventoried for immediate off-the-shelf availability. CDI is also leveraging its deep expertise to differentiate additional cell types for use in research and clinical applications.
Industrial Manufacturing Infrastructure
With over 2,000 square feet of flexible and expandable manufacturing space in Wisconsin and California, CDI can produce approximately 70 billion iPS cells per month and then differentiate them into billions of cells of various types.
Unique Quality Management System
A critical component of CDI’s iPS cell platform is the rigor of our quality management system (QMS). As a company that manufactures products for the research market, we have adopted concepts from the International Organization for Standardization (ISO) 9001. In addition, as iPS cell technology is rapidly expanding beyond research into the clinical space, we have incorporated elements of current good manufacturing practice (cGMP) into our core QMS. This innovative QMS positions CDI as a tools manufacturer with an eye towards production of clinical-grade products.
Broad Intellectual Property
CDI maintains a portfolio of over 800 patents and patent applications, which includes owned and licensed technology around iPS cell reprogramming, cell culture, genetic engineering, cell differentiation, and methods for using differentiated cells. CDI possesses the necessary intellectual property rights to produce and sell iPS cells and iPS cell-derived products and conveys a limited use license to its customers.
CDI is the only entity, industrial or academic, that is licensed for commercial use of both the Yamanaka factors (licensed to CDI by iPS Academia Japan) and the Thomson factors (licensed exclusively to CDI by the Wisconsin Alumni Research Foundation, WARF). CDI is an owner of the episomal reprogramming technique, which enables reprogramming of somatic cells to iPS cells without integrating DNA into the target cell genome. Furthermore, CDI is the exclusive licensee of the WARF patents that have been filed on episomal reprogramming and holds licenses to patents (including the Geron patents licensed by General Electric) necessary to make and sell many iPS cell-derived differentiated cells for drug testing and development.