WHY WAISMAN Clinical Production
Waisman Biomanufacturing has in-depth experience in manufacturing a wide range of biotherapeutics for human clinical trials including gene therapeutics, cell therapeutics, vaccines, and recombinant proteins. Waisman has developed platform manufacturing processes and analytical methods to support clinical production of several classes of biotherapeutics including plasmid DNA, Mesenchymal Stromal Cells (MSCs), human Embryonic Stem Cells (hESCs), adenoviral vectors, and lentiviral vectors. In addition, Waisman has supported the development and clinical production of a number of novel types of biotherapeutics from process development through to aseptic fill and finish.
With a broad range of experience in product development and clinical production, Waisman has the insight and expertise to identify and address key issues as we work with you to produce your clinical trial material. Waisman also provides full support for your IND filing by providing QA audited batch records and support for your Investigational New Drug (IND) filing including Chemistry, Manufacturing, and Control (CMC) support and access to the Waisman Biomanufacturing Type V Facility Master File.