Want to Scale-Up Production?
The Center for Biocatalysis and Bioprocessing (CBB) can be your reliable CDMO and collaborator for bridging the gap between laboratory discoveries and commercial bioprocessing.
With extensive experience in producing a wide array of protein types, the CBB offers comprehensive microbial fermentation and protein purification services tailored to the scale-up needs of academic, start-up, corporate and government clients. Typically, scale-up begins with a tech-transfer of the client’s existing bioprocesses followed by sequential scale-up steps to achieve a targeted volume for the client’s fermentation and purification needs. Scale-up processes starting from shake flasks are common, and fermentation volumes of 30, 100, or 1000 L fermentations are available.
Whether you're involved in early-stage research, process development, commercialization, or designing material for a Phase I clinical trial, we are committed to providing high-quality, reliable proteins that meet your bioprocessing and regulatory needs.
Microbial Manufacturing Services
The Center for Biocatalysis and Bioprocessing (CBB) specializes in microbial fermentation and protein purification, with extensive experience in the expression and purification of recombinant proteins of research and commercial value. We offer both non-cGMP and cGMP-compliant production capabilities. Our facilities are equipped to manufacture proteins for a wide variety of applications, including those for commercial sales as well as proteins suitable for Phase I clinical testing. Our services support clients across the academic, biotech, life sciences, and pharmaceutical sectors.
We invite you to explore our Available Services and Featured Instruments to learn more about our capabilities. If you don’t see a specific service listed related to your project, please reach out—we’re happy to discuss and develop custom solutions for your bioprocessing needs.
Non-cGMP Facility
Our non-cGMP Facility is fully equipped with advanced technologies & instruments to provide both upstream & downstream process development services to our clients, from strain development to large scale manufacturing. All projects are carried out by full-time staff with years of experience in research & process development.
cGMP Facility
The cGMP Manufacturing Facility at CBB is capable of producing protein products for Phase-1 clinical trials. This cGMP Manufacturing Facility and the Non-cGMP Facility share similar equipment, allowing for efficient process transfer between the two facilities. Our facility strictly follows the 2008 FDA guidance for cGMP manufacturing of materials for Phase-1 investigational drugs.
Microbial Manufacture of Protein Products
The Center for Biocatalysis and Bioprocessing (CBB) specializes in microbial fermentation and protein purification at a variety of scales. Fermentation scales are available with working volumes of 5, 30, 100, and 1000 L.
Our experienced team of professionals supports clients through every stage of bioprocess development—from cell banking and fermentation scale-up to protein purification, including solubilization of inclusion bodies and protein refolding, when necessary. All bioprocessing activities are documented by a rigorous set of client-approved batch records. Client initiated audits are permitted to ensure transparency and compliance.
New projects can typically begin within 4–6 weeks after completion of all contract documents. Documents include a Confidential Disclosure Agreement, Master Service Agreement, Project Order for specific bioprocessing to run, and, if necessary, a Quality Agreement for cGMP projects. This 4–6-week period includes time to prepare initial client-approved batch records.
With a dedicated professional staff and a strong track record of successful campaigns, the CBB has become a trusted manufacturing partner for academic institutions, biotech startups, life science vendors, and pharmaceutical companies worldwide.
What we Produce
Manufacturing at the Center for Biocatalysis and Bioprocessing (CBB) can produce the following products: 1) purified protein, 2) cell paste, 3) recovered inclusion bodies, and 4) partially purified protein. Purified protein can be provided in a concentration form dissolved within a client-specified formulation buffer. Typically, purified protein is provided as a bulk protein product that can be shipped globally to a location specified by the client.
If preferred, the CBB can purify protein from client generated cell paste.
Features and Restrictions
The Center for Biocatalysis and Bioprocessing (CBB) establishes a tight collaboration with our clients to ensure transparency and accuracy in both the upstream and downstream bioprocesses. As an example, the CBB will work closely with the client to prepare the batch records required for each bioprocessing campaign. A copy of each executed batch record is provided to the client following a full technical review.
All bioprocessing operations are performed by professional staff fully trained to perform each unit operation. Projects are limited to BSL-1, non–spore forming microbial organisms.
cGMP follows the 2008 guidance instituted by the U.S. Food and Drug Administration specifically for the manufacturing of materials for Phase 1 investigational drugs.
Explore our services or contact us today:
Email: biocatalysis@uiowa.edu
Phone: +1 319-335-4900
