Reclaim Pharmaceutical Waste Management, LLC — Department of Health and Human Services SBIR Phase I: 100

Description

DESCRIPTION provided by applicant Protein therapeutics are the fastest growing segment of the pharmaceutical market accounting for one third of the overall late stage drug development pipeline and anticipated to represent of the total pharmaceuticals market value by However two significant challenges must be overcome to maximize patient benefit and access to biologic drugs Patient immunogenicity remains a significant problem for biologic drugs resulting in patient non response rates of up to or more over the course of long term treatment Denatured and aggregated proteins in biologic drugs are a known cause for immunogenicity so maintaining their D structure is therefore critical for ensuring patient safety and drug efficacy Lack of low cost generic competition looms as a pressing issue with biologic drug patents worth more than $ billion in annual US sales expiring before However one challenge slowing FDA approval of biosimilar drug applications is the inability to ensure that the D structures of proposed biosimilars are the same as the original branded drug Unfortunately current analytical strategies are inadequate for delivering easy to obtain high resolution analyses of protein D structure In response ReclaimRx and its research partners at Indiana University and University of Massachusetts propose to develop a mass spectrometry method that uses labeling to detect changes in protein D structure This method will be quick easy to use and high resolution Preliminary studies have demonstrated the strong potential for success of the proposed labeling approach by detecting changes in the D structure of proteins microglobulin human growth hormone and immunoglobulin G in response to forced degradation conditions Phase I efforts will build upon this work by demonstrating the feasibility of the proposed technology This will be achieved through the following Specific Aims Demonstrate effective detection of the structural degradation of proteins EPO human growth hormone and an IgG mAb in response to thermal and oxidative forced degradation conditions and Develop a software pipeline specifically designed for protein covalent labeling studies The simplicity of this approach allows ReclaimRx an Indiana based small business to commercialize this method via a fee for service offering where client will send samples to be analyzed in ReclaimRxandapos s facilities This service will include data analysis via software that converts the MS files into user friendly formats Phase II efforts will focus on developing the technology as a kit that can be purchased to allow researchers to perform the analysis in their own lab and further refining the software pipeline for commercial use and test conditions relevant to potential customers PUBLIC HEALTH RELEVANCE High resolution measurements of the D structure of therapeutic proteins is essential for ensuring the safety and efficacy of biotech drugs and is a key element in enabling the introduction of generic competition for offpatent branded drugs via biosimilars Unfortunately current analytical strategies are inadequate for delivering easy to obtain high resolution analyses of protein D structure In this SBIR project ReclaimRx LLC will develop a mass spectrometry method that uses labeling to detect changes in protein D structure providing high resolution protein structure analyses without the limitations of existing methods