Center for Biocatalysis and Bioprocessing

Center for Biocatalysis and Bioprocessing

生物技术研究

Coralville,Iowa 689 位关注者

CDMO Protein Bioprocessing Facility Fermentation/Protein Purification non-cGMP and cGMP Production for Phase-1 clinical

关于我们

-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 - ?KTA 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

网站
https://cbb.research.uiowa.edu/
所属行业
生物技术研究
规模
11-50 人
总部
Coralville,Iowa
类型
非营利机构
创立
1983
领域
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、?KTA Purification Systems、Research & Process Development、Batch & Fed-batch Fermentation、Fermentation Scale-up、BSL-1 Microbial Expression Systems、Biotechnology和Chromatography

地点

  • 主要

    2501 Crosspark Road

    Suite C100

    US,Iowa,Coralville,52241-3210

    获取路线
  • 2656 Crosspark Road MTP2

    Suite 300

    US,Iowa,Coralville,52241

    获取路线

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