Centrifugal Bioreactor technology

KBI Biopharma is commercializing a proprietary Centrifugal Bioreactor technology, which will have numerous advantages over conventional biomanufacturing technologies – and will provide a distinct advantage for our customers.

Centrifugal Bioreactor (CBR) applies advanced fluidized bed methodology to allow cells producing recombinant therapeutic and vaccine products to be immobilized at very high densities without use of membranes or other solid support or retention devices.

CBR technology allows true continuous production of uniform high quality product at significantly lower capital and operating cost. The technology facilitates linear process scale-up, providing considerable regulatory advantages over conventional "stirred tank” biopharmaceutical production systems. The technology is also applicable to the purification of biopharmaceuticals via the provision of rapid and high resolution separation using advanced chromatography resins within the CBR rotor.

Benefits of CBR:

• Potential for dramatic reduction in cost-of-goods for recombinant proteins and monoclonal antibodies from high-density fluidized cell beds
• Significantly improved process yields
• Production of more uniform product than obtained using conventional technology, leading to improved purity profile and potentially higher yields of active product
• Improved production throughput and efficiency through decreased "downtime" and changeover requirements
• Linear scale-up, requiring less validation and eliminating technical challenges
• Potentially disposable production technology
• Decreased capital and facility requirements
• Highly efficient use of utilities
• High concentration product output facilitates efficient and cost-effective downstream processing (purification)

Intellectual Property

KBI Biopharma has extensive and broad intellectual property surrounding the CBR in all its forms, and additional patent filings cover new applications and improvements as they are developed. We are the exclusive licensee of all CBR technology and know-how for all areas in the field of use, including all pharmaceutical applications (production of proteins, peptides, DNA or small molecules from cells in culture), chromatography as applied to pharmaceutical separations, and drug development applications, such as ex vivo toxicology. To date we have 12 patents issues and 4 patents pending.

Key Patents

• U.S. Patent # 5,622,819 "Centrifugal Fermentation Process," issued April 22, 1997: Covers any method and apparatus using gravity and countering liquid flow in modified counter-flow centrifugation to immobilize cells.
• U.S. Patent # 5,821,116, issued October 13, 1998 (divisional of '819): Covers any apparatus for continuous culture of biocatalysts using the above method, with horizontal rotational axis. The rotor can be any shape, size or dimension, except for having parallel walls.
• U.S. Patent # 6,133,019, issued October 17, 2000 (CIP of '116): Modified CBR, specifically claiming the second-generation rotor design.
• U.S. Patent # 6,214,617, issued April 10, 2001 (CIP of '019): Covers specific examples of use, such as toxin removal from aqueous solutions; specifically covers secreted products of cells (mammalian, prokaryotic, plant, fungal, insect, yeast and others are specifically claimed).