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High Efficiency Purification of Immunotherapeutics with Nanoporous Composite…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96235
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
GM095039
Solicitation Year:
N/A
Solicitation Topic Code:
NIGMS
Solicitation Number:
N/A
Small Business Information
TIAX LLC
35 Hartwell Avenue Lexington, MA 02421-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: High Efficiency Purification of Immunotherapeutics with Nanoporous Composite Memb
Agency: HHS
Contract: 1R43GM095039-01
Award Amount: $137,388.00
 

Abstract:

DESCRIPTION (provided by applicant): Monoclonal antibody (mAb) therapeutics have become the majority of drugs being developed by the pharmaceutical industry, due to their ability to target and treat specific diseased cells. In recent years, improvements i n bioreactor design and host cell engineering have resulted in much higher titer counts, largely keeping up with the demand for large scale production. Unfortunately, downstream processing, is a large bottleneck in mAb production, and currently accounts fo r more than 80% of mAb production cost. In addition, high titers can lead to the formation of antibody aggregates, which are known to exhibit antigenic activity and can lead to undesirable immune responses in patients. As such, scalable methods that effici ently improve the purification of mAbs, especially from multimeric aggregates, are highly desired. We propose to demonstrate the purification of mAbs using a high-efficiency nanoporous composite membrane and to demonstrate their superiority to current m embranes. These nanoporous composite membranes will offer rapid processing and high purity relative to current membrane processes, thereby dramatically improving purity and reducing the amount of additional time, labor and cost intensive purification neede d to achieve purification of mAbs from multimeric aggregates. In Phase I, we will purify a model mAb from multimeric mAb aggregates using a nanoporous composite membrane, which will have a high pore density and a narrow pore size distribution. We will c ompare the efficacy of this purification, in terms of aggregate removal and recovery of monomeric mAb, to that of selected commercial membranes with similar nominal pore sizes. In Phase II, we will extend this demonstration to a prototype manufacturing pro cess and investigate the effects of filtration conditions and fouling on the purification. We will also work with a commercial partner to integrate our membrane into a complete purification process. PUBLIC HEALTH RELEVANCE: In the last twenty years, im proved manufacturing methods have led to a marked improvement in the production of biopharmaceuticals such as monoclonal antibodies (mAbs); however, the resulting high titer streams have greater amounts of impurities which current downstream processing tec hniques struggle to handle. Consequently, downstream processing has become a huge percentage of mAb production costs, and improvements that reduce these costs and increase efficiency will be able to dramatically improve mAb production, thereby speeding pro gress through trials and ultimately improving patient health. Membrane separations are one of the least expensive and most efficient purification processes, and improving their purification ability reduces or eliminates the need for other more costly and t ime consuming processes.

Principal Investigator:

Bradford A. Pindzola
6174985137
PINDZOLA.BRAD@TIAXLLC.COM

Business Contact:

Renee Wong
wong.renee@tiaxllc.com
Small Business Information at Submission:

TIAX, LLC
TIAX, LLC 35 HARTWELL AVENUE LEXINGTON, MA 02421

EIN/Tax ID: 146047874
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No