Human Embryonic Stem Cells (hESCs) provide clinical scientists with unprecedented opportunities to economically produce human cell types, at an industrial scale, for the treatment of diseases that have avoided treatment using available medical technologies. BioTime and its family of companies employ deep knowledge and skill in various cell culture and manufacturing technologies including, stem cell derivation, culture, expansion, differentiation and manufacturing. These procedures and technologies must be done in a manner that is acceptable under strict quality control standards. The end product must be free from exposure to non-human biological materials, must pass rigorous functional and safety tests and must be packaged in a manner that allows ease of storage, transport and patient application to be acceptable for use in humans.
Human embryonic stem cells can be manipulated in the laboratory to grow in great numbers and become the types of cells clinicians need to treat these diseases. However, hESCs must be derived and cultured carefully to result in pure cultures of specific therapeutic cell types. The end product must be free from exposure to non-human biological materials and must pass rigorous functional and safety tests to be acceptable for use in humans.
Stem cell expansion and differentiation technologies involve the development and implementation of manufacturing methods that expose hESCs to highly specific biologic molecules under highly specific physical conditions and time periods, causing the stem cells to grow and change to the therapeutic cells sought by the medical community. Scaling these methods to manufacture sufficient quantities of therapeutic cells at low cost is also a daunting technical challenge. Scientists and technicians at BioTime and its family of companies has developed technologies to overcome these challenges.
Our scientists have also developed methods of packaging and applying these cells so doctors can effectively use them to treat patients in need. These technologies, protocols and methods are strictly compliant with requirements set forth by regulatory authorities, including manufacture under current Good Manufacturing Practice (cGMP) regulations.