Software for Determining Proteoform Heterogeneity and Protein Expression Fidelity

The importance of large protein drugsbiopharmaceuticalsand their generic counterpartsknown as biosimilarshas created a need for improved analytics to facilitate biopharmaceutical research and to combat adverse drug reactionsThe recombinant protein expression process is inherently prone to low level errors resulting in sequence variants caused by amino acid misincorporationwhich are observed in both native and expressed proteinsThe expression system and culturing conditions can influence protein product quality attributessuch as translational fidelity and post translational modificationsThese protein variantsthose arising from sequence variants and post translational modificationsimpact product quality in a number of ways that include altered functionactivityligand substrate bindingand perturbed protein folding leading to protein aggregationdecreased serum half lifeand diminished therapeutic efficacy to name but a few consequencesAn additional concern for biopharmaceuticals is that sequence variants can potentially induce an undesired immune responseWorries for efficacy and patient safety necessitates the need to characterize these low level protein variantsThe detection and quantification of protein variants are challenging currently extremely challengingThe goal of this Phase I STTR will evaluate the feasibility of a new software package to identify and quantify low level protein variantsUpon successful completion of our programwe will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research The importance of large protein drugsbiopharmaceuticalsand their generic counterpartsknow as biosimilarshas created a need for improved analytics to facilitate biopharmaceutical research and to combat adverse drug reactionsThe biopharmaceutical industry acknowledges the critical role that protein heterogeineity plays in the safety and function of biotherapeuticsThis Phase I STTR will demonstrate feasibility of an new software package to identify and quantify low level protein variantsUpon successful completion of our programwe will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research