SBIR---Promotion of Wound Vascularization and Closure

Research project

Description

This program will develop methods for the macromolecular characterization of raw materials (gelatin and dextran) and E-
Matrix™. E-Matrix™ is a co-polymer of gelatin and dextran stabilized by the addition of polar amino acids. Results of
this research will lead to providing raw material specifications for macromolecular components used in the manufacture of
E-Matrix™ and characterizing the size and conformation of the E- Matrix™ copolymer and the macromolecular
interactions between gelatin and dextran in the final product. Multiangle laser light scattering (MALLS)in conjuction
with size exclusion column chromatography (SEC) will be used to determine the absolute MW characterization of gelatin
and dextran, the key polymeric components of E- Matrix™ . This research will use SEC-MALLS to establish acceptable
molecular weight distribution profiles of these components for use in manufacturing E-Matrix™. Different gelatin and
dextran lots (3 to7) will be characterized using those methods. This research will establish dextran and gelatin raw
material specifications based on SEC-MALLS measurements. Absolute MW characterization of macromolecular
components in E-Matrix™. Once molecular weight profiles of gelatin and dextran have been specified using SEC-
MALLS, characterization of the macromolecular species in the fully formulated E- Matrix™ will be completed. The
molecular weight characteristics of E-Matrix TM (average molecular weight, number average molecular weight, and mean
radius of gyration) will be reported for a series of at least 10 lots of E- Matrix™ and a final product release specification
based on molecular weight characterization will be established. The sensitivity of these molecular weight characteristics
of E-Matrix™ will be probed using test E-Matrix™ lots prepared with differing lots of gelatin. Stability Studies.
Macromolecular changes in three dedicated lots of E-Matrix™ during accelerated and real-time storage will be monitored
to support Encelle's product stability and shelf-life data. Transfer of SEC_ MALLS Methods to Encelle. These studies
will conclude with a transfer of SEC-MALLS methods from UNC to Encelle. These methods will be appropriate for use as
a test for final product release specifications
StatusFinished
Effective start/end date6/1/035/31/06

Funding

  • Industry Sponsor

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gelatin
dextran
molecular weight
light scattering
lasers
chromatography
methodology
raw materials
manufacturing
testing
composite polymers
storage time
shelf life
polymers
amino acids