Waisman Clinical BioManufacturing

Waisman Clinical BioManufacturing Overview

The primary mission of Waisman Biomanufacturing is to provide cGMP manufacturing services to serve researchers, clinicians and business ventures in the development of novel biological therapies for clinical trials.

With broad and comprehensive capabilities, Waisman Biomanufacturing is uniquely situated and highly qualified to lead clients through the complex process of bringing a novel therapeutic into the clinic. Integral to any product campaign is a well-thought out product development plan. You can rely on our business manager and team of project leaders to work closely with you to maintain an on-going flow of communication and develop a time and cost effective plan that meets your needs. Using our expertise
in process development and manufacturing we can translate your bench top process to a large scale manufacturing process.

Waisman has extensive experience in cGMP production of biologics for phase I/II human clinical trials including:

• plasmid DNA
• recombinant proteins
• cell therapeutics
• viral vectors
• vaccines


In addition, Waisman provides aseptic filling and comprehensive
Chemistry, Manufacturing, and Control (CMC) support for Investigational New Drug (IND) filings. Our biotherapeutic development model incorporates key translational components such as process development, assay development, process qualification/
validation, assay qualification/validation, cGMP manufacturing of pre-clinical and clinical material, quality control testing, and full CMC documentation
including Facility Master File (CBER/CDER).

Waisman has a proven track record of success in making clinical trial material for universities, the National Institutes of Health (NIH), as well as both small and large companies nationally and internationally. Since opening its cGMP facility in 2001, Waisman Biomanufacturing has manufactured over 300 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.