Contract Fermentation and Bioprocessing

CBB offers an experienced professional staff and state-of-the-art fermentation and purification facilities to perform confidential contract services. Operations in the Good Laboratory Practices (GLP) facility started in 1995. During 2005, CBB acquired Good Manufacturing Practices (GMP) facility with three purification suites. In 2006, CBB expects to complete a cGMP fermentation suite containing 30, 100, and 300-liter fermentors. The GMP facilities are located on the Oakdale Campus adjacent to the GLP laboratories.

CBB staff is committed to working collaboratively with clients, and usually interacts with more than 60 different clients each year. At weekly scheduling meetings, the staff typically discusses 15 active projects. Several long-term client-CBB collaborations span more than 10 years and involve more than 40 separate projects each. CBB clients cover the complete range of corporate size, and include the nation's foremost universities and institutes. Geographically, clients range from Europe to New Zealand with high concentrations on the East and West Coasts of the United States.

An experienced expert staff operates CBB’s state-of-the-art upstream and downstream processing facilities. The GLP staff develops, evaluates, optimizes, and scales up bio-based products using 23 fermentors up to 1,000 liters. Typically, they bring research findings from the bench through the first stages of scale-up. The more than 20-member lab staff's extensive experience includes a wide-range of organisms, notably high-cell-density recombinant E.coli and Pichia pastoris. Products produced cover the complete range of interest - vaccines, enzymes, immobilized catalysts, antibiotics, therapeutics, nucleotides, polysaccharides, peptides, polymers, and biochemicals. The GLP development process is rapid and economical, after which, CBB has converted processes to GMP status. The cGMP staff produces materials acceptable for Phase I and Phase II clinical trials.

CBB produces bulk biopharmaceuticals for evaluation. The Center has considerable experience purifying fermentation-produced biological materials. Typical operations may include diafiltration, ultrafiltration, complex chromatographic separations, and lyophilization.

Clients find the CBB's business practices fast, efficient and easy. The period from initial contact to the start of work in the laboratory often takes only a few weeks. Typical projects start with a Confidentiality Agreement, allowing the exchange of necessary information. CBB follows this with a Service Agreement and/or proposal outlining the protocol, estimated costs and timing.