cGMP Manufacturing
Waisman Biomanufacturing has extensive experience in manufacturing a wide range of biotherapeutics for human clinical trials including plasmid DNA, cell therapeutics, viral vectors, vaccines, and recombinant proteins. Waisman has segregated manufacturing areas and platform manufacturing processes to support clinical production of several classes of biotherapeutics including plasmid DNA, stem cell-based therapeutics, and viral vectors and vaccines. All clinical production projects are performed under current Good Manufacturing Practice (cGMP) guidelines for early-stage clinical trials with comprehensive documentation of all manufacturing operations and quality control testing. All documentation is reviewed by independent Quality Assurance group prior to release of the product to the clinical trial site. Waisman provides full support from clinical production through to IND filing by providing QA audited batch records and support for your Investigation New Drug (IND) filing including Chemistry, Manufacturing, and Control (CMC) support and access to the WCBF Type V Facility Master File
Link to Clinical Production for additional information regarding our cGMP Manufacturing capabilities.
