cGMP Facilities

cGMP Purification Suites

During 2005, CBB acquired a 7,000-ft 2 operational cGMP downstream processing facility containing three purification suites. In 2000, the CBB staff prepared the original GMP facility design for a client and assisted in facility operations. With the acquisition, CBB hired key staff involved in facility operations since 2000. CBB expects to complete installation of cGMP fermentation suite during 3Q2006 in a dedicated 2,000-ft 2 facility adjacent to the GLP laboratories.

The cGMP facilities offer state-of-the-art manufacturing with fully compliant documentation.

CBB develops processes in its existing GLP laboratory leading to final protocols. After development is complete, CBB finalizes documentation and transfers processes to the cGMP facility. This offers an economical approach to rapidly establishing a sound process on a cGMP platform.

cGMP Fermentor

A dedicated QA/QC group characterizes product to validate conformity to cGMP standards. CBB offers extensive documentation packages to its cGMP clients including the assistance in writing CMC sections. Full time professionals trained in cGMP operations staff the laboratories. Similar to the existing GLP approach, CBB will write dedicated SOP's for the operation of new equipment.

Akta Process Skid

Direct questions about CBB contract work to Biocatalysis@uiowa.edu..

Back to Top