CMC Biologics has successfully manufactured more than 120 biological projects for pre-clinical studies through commercial approvals. Our U.S. facilities in Berkeley, CA and Seattle, WA—and our European facility in Copenhagen, Denmark—offer multiple cGMP manufacturing lines at a variety of scales for mammalian cell culture and microbial fermentation.
The innovative design of our state-of-the art facilities allows for capacity and technological flexibility, while ensuring compliance with the strict biopharmaceutical regulations required for cGMP operations.
CMC Biologics has provided solutions to customers on five continents, and has developed more than 60 mammalian cell lines and processes from pre-clinical through commercial production. We have skillfully developed upstream processes for numerous expression systems, including our proprietary CHEF1® Expression Platform, which has been used extensively to create clinical and commercial production cell lines.
Perfusion manufacturing of biologics is the method of choice for difficult to produce or inherently unstable proteins. Due to this challenge, there are few companies out there that can do offer this service. CMC Biologics has successfully produced several molecules using perfusion manufacturing methods, enabling us to offer it not only as a service, but as a solution to our customers’ manufacturing challenges.
Remove the uncertainty of getting cGMP material for clinical studies, allowing you to concentrate on other critical components of your development program. CMC Biologics’ CHEF1® Expression Platform and well-developed antibody production platform enables rapid and seamless process transfer to cGMP manufacturing. We have the innovation to manufacture 500g of your IgG monoclonal antibody in a short amount of time, and within budget.
CMC Biologics is one of only a few CDMOs that have extensive expertise with microbial manufacturing using both bacterial and yeast fed-batch processes.
We have successfully expressed antibody fragments, growth factors, antigens, enzymes and other proteins using multiple modes of expression—including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies.
We optimize media, feeds and standard processes for high cell density E. coli and P. pastoris production.