Waisman Biomanufacturing

Services and Products

Overview

With broad and comprehensive capabilities, Waisman Biomanufacturing is uniquely situated and highly qualified to lead clients through the complex process of bringing a novel vaccines and therapeutics into the clinic. Our Industry-Academia hybrid operational model starts with an industry-experienced leadership team that negotiates a flexible and time and cost-effective development plan that meets your needs. 

Subsequently, our highly collaborative Process Development, Manufacturing, and Quality Control scientific team works to translate your bench top process to a scalable biopharmaceutical manufacturing process. Using this strategy Waisman routinely produces CGMP grade material suitable for human clinical trials for a wide variety of applications. 

Process Development

Full support for clinical process development including microbial fermentation, mammalian cell culture development, research cell banking, and downstream processing for recombinant proteins, plasmid DNA, and viral vectors/vaccines.

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GMP Manufacturing

Custom manufacturing of plasmid DNA, recombinant proteins, live microbial products, viral vectors/vaccines, cell therapeutics, or standalone aseptic fills for human clinical trials.

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Quality Control

Comprehensive product testing and analytical methods development/qualification/validation to support process development and CGMP release testing.

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QA and Regulatory

Complete CGMP documentation and support for of Chemistry, Manufacturing, and Controls (CMC) sections of regulatory filings in eCTD format.

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