Glycobac, LLC — Department of Health and Human Services SBIR Phase I: Project Summary / Abstract Therapeutic proteins, or biologics, represent a 100 billion m

Description

Project Summary / Abstract Therapeutic proteins, or biologics, represent a 100 billion market that includes drugs such as antibodies, hormones, and many others. The clinical efficacy of biologics is critically determined by their circulating half-lives.Hence, various methods have been developed to increase their circulating half-lives by reducing clearance rates. This is commonly achieved by chemically conjugating biologics with biocompatible polymers in vitro. However, chemical conjugation is expensive,complicated, and often results in substantial losses of specific activity as well as a heterogeneous product mixture. These serious drawbacks have created a demand for a technology that can add biocompatible polymers to biologics without in vitro chemistry. To meet this demand, GlycoBac proposes a new, innovative method to add polysialic acid to biologics during their biosynthesis. Polysialic acid is (PSA) naturally found in the human body, and is a fully biocompatible, biodegradable and non-immunogenic