-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
-
Industry
-
Biotechnology Research
-
Company size
-
11-50 employees
-
Headquarters
-
Coralville, Iowa
-
Type
-
Nonprofit
-
Founded
-
1983
-
Specialties
-
Upstream & Downstream Bioprocessing, Clonal Selection, Gene Cloning, Analytical Services, Biocatalysis, Protein Purification, Fermentation, Microbial Manufacturing of Protein Products, Protein Products for Phase-1 Clinical Trials, Protein Solubilization and Refolding, cGMP Manufacturing, Cell Banking, Homogenization-Extraction, ÄKTA Purification Systems, Research & Process Development, Batch & Fed-batch Fermentation, Fermentation Scale-up, BSL-1 Microbial Expression Systems, Biotechnology, and Chromatography
