The GenNext Phase I SBIR submssion entitled Liquid Chromatography Flash Oxidation (LC-Fox) Protein Footprinting System, is responsive to the ackowledged need for new and improved tools for higher order structural analysis (HOS) of biopharmaceuticals. Hydroxyl radical foot-printing (HRPF) is a HOS analytical technique that involves the irreversible labeling of a proteins exterior by reaction with hydroxyl radicals with subsequent MS analysis to identify the outer portions of the protein. When applied to dynamically changing mixtures of conformation, HRPF fails to elucidate individual conformers. Our LC-Fox Protein Footprinting is a new, bench-top method to probe dynamic conformational heterogeneous mixtures that can be separated via various forms of chromatography, including size exclusion (SEC), ion exchange (IEX), and hydrophobic interaction chromatography (HIC). In Phase I we will create a prototype system to be tested with isocratic SEC. GenNext Technologies is the only company commercializing technology and products for HRPF HOS analysis. Our overarching goal is to convert the HRPF process from an academic research experiment into a broadly adopted and valuable HOS analytical tool. Our LC-Fox system is predicted to make substantial impact in the field of biopharmaceutical research / development, formulation, and drug delivery, as it will enable the detection and characterization of unwanted conformers (and potential adverse drug reactions) created during the genesis and introduction of new biotherapeutics.
Public Health Relevance Statement: The importance of biopharmaceuticals has created a need for improved analytics to facilitate biopharmaceutical research. Our Phase I SBIR proposal will create an improved means to study the higher order structure of heterogenoues mixtures of biological conformers facilitating proteomics and pharmaceutical research and development. Upon successful completion of our program, we will demonstrate the transformative nature of our new technology to positively impact biopharmaceutical research.
Project Terms: Adoption; Award; Behavior; Biological Products; Biologic Products; Biological Agent; biologics; biopharmaceutical; biotherapeutic agent; Biological Response Modifier Therapy; Biological Therapy; biological therapeutic; biological treatment; biologically based therapeutics; biotherapeutics; biotherapy; Chromatography; Liquid Chromatography; Comparative Study; Crystallization; Crystallography; Crystallographies; Dangerousness; Data Analyses; Data Analysis; data interpretation; Environment; Feedback; Goals; Heterogeneity; Ion Exchange; Lasers; Laser Electromagnetic; Laser Radiation; Light; Photoradiation; Manuals; Marketing; Methods; Modernization; Molecular Conformation; Molecular Configuration; Molecular Stereochemistry; conformation; conformational; conformational state; conformationally; conformations; oxidation; Patients; Pharmacology; Play; Production; Protein Conformation; Post-Translational Protein Processing; Post-Translational Modification Protein/Amino Acid Biochemistry; Post-Translational Modifications; Post-Translational Protein Modification; Posttranslational Modifications; Posttranslational Protein Processing; Protein Modification; Proteins; Research; research and development; Development and Research; R & D; R&D; Research Personnel; Investigators; Researchers; Role; social role; Safety; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Computer software; Software; Solvents; Technology; Testing; Time; Hydroxyl Radical; Hydroxyl; Drug Delivery; Drug Delivery Systems; Label; improved; Area; Phase; biologic; Biological; Link; Individual; Biological Function; Biological Process; Letters; Heat Shock; Heat-Shock Reaction; Heat-Shock Response; Immunological response; host response; immune system response; immunoresponse; Immune response; Companions; tool; instrument; Nature; programs; Adopted; Reaction; Source; Techniques; System; interest; dosimetry; Structure; Hydrophobic Interactions; novel; Exclusion; new technology; novel technologies; Reporting; Appearance; Sampling; Proteomics; therapeutic protein; native protein drug; pharmaceutical protein; protein drug agent; protein-based drug; Protein Footprinting; D2E7 antibody; adalimumab; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; pharmaceutical; Pharmacologic Substance; preventing; prevent; Address; Data; Detection; Higher Order Chromatin Structure; Higher Order Chromatin Folding; Higher Order Structure; National Institute of General Medical Sciences; NIGMS; Resolution; resolutions; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; Development; developmental; analytical tool; conformer; prototype; commercialization; operations; operation; dynamical system; dynamic system; Formulation; experiment; experimental research; experiments; experimental study; adverse drug reaction; biopharmaceutical industry; biopharmaceutical company; Compensation
