Waisman Biomanufacturing

Waisman Biomanufacturing (WB) provides cGMP manufacturing services to serve biotech companies, researchers, and clinicians in the development of novel biotherapeutics for clinical trials. Since opening its cGMP facility in 2001, WB has manufactured over 320 clinical grade products and has earned a reputation for working closely with clients for cost effective and timely manufacture of quality products. We strive to meet these high standards with each product campaign.

With in-depth experience in manufacturing a wide range of biotherapeutics for human clinical trials including gene therapeutics, cell therapeutics, vaccines, and recombinant proteins WB is well situated to move your therapy into clinical trial.

WB 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, lentiviral vectors and AAV. In addition, WB 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, WB has the insight and expertise to identify and address key issues as we work with you to produce your clinical trial material. WB also provides full support for your Investigational New Drug (IND) filing by providing QA audited batch records, Chemistry, Manufacturing, and Control (CMC) support and access to the Waisman Biomanufacturing Type V Facility Master File.