-CDMO Microbial Manufacturing Facility for Protein Products- The CBB specializes in microbial manufacturing of protein products. Our non-cGMP Facility and cGMP Facility are fully equipped with advanced technologies & instruments to provide both upstream & downstream process development services to our clients. All projects are carried out by full-time staff with years of experience in research & process development. The cGMP Manufacturing Facility at CBB is capable of producing protein products for Phase-1 clinical trials. Our facility strictly follows the 2008 FDA guidance for cGMP manufacturing of materials for Phase-1 investigational drugs. Listed below are some of our available services. Upstream Process Development - Cloning/Clonal Selection - Fermentation Optimization (Batch & Fed Batch) - Fermentation Scale-up (2-L, 10-L, 30-L, 100-L, and 1,000-L) - BSL-1 Microbial Expression Systems Downstream Process Development - ÄKTA Purification Systems - Cell Disruption & Clarification - Protein Solubilization & Refolding - Multiple Chromatography Techniques - Tangential Flow Filtration cGMP Manufacturing Services (protein products for Phase-1 only) - Cell Banking - Fermentation (30-L to 300-L) - Protein Purification (2 ISO7 clean rooms) Other Services (available at The University of Iowa) - Fill-Finish Services - Clinical Trials