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A Novel Hybrid Solid Support for Cost-Effective, Large-Scale Oligonucleotide…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
93840
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
GM087788
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
Prime Synthesis
2 New Rd., Suite 126 Aston, PA 19014-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2009
Title: A Novel Hybrid Solid Support for Cost-Effective, Large-Scale Oligonucleotide Synt
Agency: HHS
Contract: 1R43GM087788-01
Award Amount: $97,815.00
 

Abstract:

DESCRIPTION (provided by applicant): As an increasing number of DNA and RNA-oligonucleotide-based drugs are moving through clinical trials, the pharmaceutical industry is focusing on ways to bring these novel therapeutics to market at a competitive prices. The primary goal of this project is to help reduce the cost of producing oligonucleoside-based drugs, via a novel synthesis solid support. It has been noted by leaders in the industry, that solid support-related costs are a major factor in large-scale oli gonucleotide production. (1). Aside from lowering the cost of the solid support itself, one way to gain economy is to increase the oligonucleotide yield per unit volume of solid support - primarily through higher initial nucleoside loadings. Improving the scalability characteristics of the solid support, so that larger batch sizes of oligonucleotides could be produced would also enhance economy. A solid support designed to improve oligonucleotide purity would result in less costly production via less purifi cation costs. At larger pore sizes (gt600 Angstroms), Controlled Porosity Glass (CPG) is often the preferred solid support for large scale syntheses of RNA and longer oligos (2), however it's maximum nucleoside loading capabilities are somewhat limited. Po rous polystyrene supports are available in much higher nucleoside loadings; however they cannot be used at these loadings for RNA and longer oligos, due to solvent swelling effects and related pore distortion. They do, however allow the use of certain synt hesis reagents that can be corrosive to glass. By combining the large and dimensionally stable pore characteristics of CPG, with the higher loading capacities of polystyrene, a superior hybrid solid support should result. The product of this research will facilitate syntheses of the newer, bulkier therapeutic oligos with higher purities than polystyrene supports, with higher yields than CPG supports, yet will be rigid enough to scale to very large reactors without suffering from the compression and reduced synthesis solution flow characteristics that would limit solvated polymer supports. Preliminary attempts in this laboratory to produce such a hybrid support have been very encouraging. PUBLIC HEALTH RELEVANCE: As an increasing number of DNA and RNA-oligonu cleotide-based drugs are moving through clinical trials, the pharmaceutical industry is focusing on how to bring these novel therapeutics to market at a competitive prices. The purpose of this project is to develop a novel solid support, which will provide a more cost-effective approach to the large-scale syntheses of such oligonucleotides.

Principal Investigator:

Dianne M. Rothstein
6105585920
DMROTHSTEIN@PRIMESYNTHESIS.COM

Business Contact:

Dianne M. Rothstein
dmrothstein@primesynthesis.com
Small Business Information at Submission:

PRIME SYNTHESIS, INC.
SUITE 126, 2 NEW ROAD ASTON, PA 19014

EIN/Tax ID: 123258126
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No