cGMP Facilities

cGMP Purification Suites

In addition to GLP process development laboratory, CBB provides cGMP fermentation and protein purification services for Phase 1 and Phase 2 clinical trial material. Since opening the fully validated cGMP laboratory in 2007, CBB has successfully executed more than 15 campaigns resulting in IND applications. All the equipment has Factory Acceptance Tests performed followed by documented IQ and OQ.

The cGMP facilities offer state-of-the-art manufacturing with fully compliant documentation of equipment, operations and facilities. The facility is open for audit by clients. GMP equipment includes three B.Braun fermentors with 30, 100 and 300 liter capacity. The culture harvest is performed by Alfa-Laval disc-stack centrifuge. Avestin Homogenizer is available for cell breakage for the recovery of intracellular products.

The downstream processing purification is conducted in three class 10,000 suites equipped with Akta purification skids CBB has experience in protein purification with a variety of resins. CBB staff is highly skilled in isolation of inclusion bodies and refolding in large scale.

cGMP Fermentor	Akta Process Skid

CBB has similar equipment in both GLP and GMP facility, which makes technology transfer seamless. Typically, CBB develops robust processes in its existing GLP laboratory. After the development is complete, CBB in consultation with client finalizes documentation and transfers processes to the cGMP facility. This offers an efficient and economical approach to rapidly establishing a sound process on a cGMP platform.

A dedicated QA/QC group closely monitors the process to validate conformity to cGMP standards. CBB offers extensive documentation packages to its cGMP clients including the assistance in writing CMC sections. QA/QC activities are staffed with full time professionals trained in cGMP operations.

A professional staff trained in fermentation and large scale bioprocessing along with cGMP regulations provides services efficiently so that you product can reach the market quickly. Please contact CBB at biocatalysis@uiowa.edu for your cGMP requirements, or call 319-335-4900.

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