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MICROHETEROGENEITY IN BIOPRODUCTS

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 39529
Amount: $749,995.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 1998
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
408 GLEN PARK DR
Bay Village, OH 44140
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ZASLAVSKY, BORIS Y
 () -
Business Contact
Phone: (216) 808-8708
Research Institution
N/A
Abstract

The innovation described in this proposal is aimed at providing a new method for characterization of lot-to-lot consistency of microheterogeneous recombinant products. The biological effect and potency of a drug is governed by the chemical structure for both traditional drugs and biopharmaceuticals. Standard analytical techniques are either inadequate for complete characterization of protein-based products or too costly and complex. This SBIR proposal is targeted at difficult quality control problems associated with microheterogeneity of widely available recombinant glycoproteins. ANALIZA is proposing to develop and validate a physicochemical test that is unique (in regard to the type of information obtained), quantitative, inexpensive (relative to present methodologies), flexible (in that it may be used for different biologicals), easy to perform and labor-efficient. The technique provides a unique and highly sensitive information on minor changes in the structure and conformation of the glycoprotein product related to its potency. Phase I research effort is designed to demonstrate feasibility of the suggested technique as a QA/QC test by developing and validating the proposed analytical methodology for analysis of a biopharmaceutical product to be determined with biopharmaceutical collaborators.

* Information listed above is at the time of submission. *

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