BioStem Life Sciences has in-depth experience in manufacturing a wide range of biotherapeutics for human clinical trials including gene therapies and cell therapeutics. BioStem has developed platform manufacturing processes and analytical methods to support clinical production of several classes of products including Mesenchymal Stromal Cells (MSCs), human Embryonic Stem Cells (hESCs), induced Pluripotent Stem Cells (iPSCs), adenoviral vectors, and lentiviral vectors. In addition, BioStem has supported the development and clinical production of a number of novel biotherapeutics from process development through to aseptic fill and finish.
With a broad range of experience in product development and clinical production, BioStem has the insight and expertise to identify and address key issues as we work with you to produce your clinical trial material. BioStem also offers full support for your IND filing by providing QA audited batch records for your Investigational New Drug (IND) filing including Chemistry, Manufacturing, and Control (CMC) support.
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If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.