GMP Manufacturing

Waisman Biomanufacturing has extensive experience in manufacturing a wide range of biologics 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 and vaccines including plasmid DNA, stem cell-based therapeutics, live microbial products, and viral vectors and vaccines. 

All clinical production projects are performed following 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 an independent Quality Assurance group prior to release of the product to the clinical trial site. Waisman provides QA-audited batch records, can support drafting Chemistry, Manufacturing, and Controls (CMC) Investigational New Drug Application sections (Module 3 eCTD), and can authorize cross-reference to the Waisman Biomanufacturing Type V Facility Master File that has been submitted electronically to FDA CBER/CDER.

Clinical Production provides additional information regarding our CGMP Manufacturing capabilities.