FiberCell Systems: validation of a large-scale, hollow fiber bioreactor

FiberCell 1

Business Description
FiberCell Systems is a leading supplier of hollow fiber bioreactors for academic and biotechnology markets. Hollow fiber bioreactors offer many significant advantages over conventional cell culture methods. The adoption of hollow fiber bioreactors for biomanufacturing has been limited due to the fact that a scalable system has not been available. Current hollow fiber systems are limited by the solubility of oxygen in cell culture media and the pumps required to generate high flow rates.

Challenge
FiberCell Systems developed and patented a novel method for generating gas delivery to hollow fiber cartridges. Instead of passively exchanging gas with a medium and flowing that medium through the cartridge, it delivers alternating amounts of medium and gas directly to the interior of the reactor. Rather than using pumps, gravity feed is utilized to circulate the medium in both directions. The challenge was to create and build a prototype system and evaluate its performance. This would be an entirely new concept in bioreactor operating principles.

MIPS Role
MIPS supported the building of the prototype, but also connected FiberCell Systems with Dr. Dean Mann at UMB, Dr. Paul Allenza and his BREP group in Mtech’s Biopharmaceutical Advancement Facility (BAF). BAF provided laboratory space, equipment, facilities and expertise to make the project possible. The combined role of MIPS, UMB and BAF was instrumental in making the project happen.

Results
Proof of principle for the basic function of the bioreactor operating principles was established. Further optimization of culture conditions and operating parameters with an ultimate goal of establishing cGMP compliance is ongoing.

FiberCell 2

MIPS-Related Quote
“MIPS provided FiberCell with both the seed money to test and evaluate a new type of bioreactor and connections with Maryland resources to make the project a success.”
–John Cadwell, President, FiberCell

Interesting Facts
Dr. George Pavlakis at the NCI in Frederick, Md. provided FiberCell with the cell line to test for protein production. If successful, it will be the first time that this protein has been available in significant quantities for animal testing. The only method that has worked for production of this protein is through FiberCell’s  smaller scale hollow fiber bioreactors. A direct comparison with the large-scale system provides valuable information about the scale-up process. This is a further example of the strength of collaboration for biotechnology research in Maryland.

Project Manager:  John J. S. Cadwell;  Principal InvestigatorDean Mann, UMB
Location:  Frederick, Maryland – Frederick County;  Project Start Date:  2/1/2011

Leading up to (and beyond) the Maryland Industrial Partnerships (MIPS) 25th Anniversary Gala, we will frequently profile one (or more) of the 500+ companies that have utilized MIPS funding to bring innovations to market and create jobs in Maryland.

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