ADVANCED MATERIALS TECHNOLOGY, INC. — Department of Health and Human Services SBIR Phase II: 400

Description

AbstractLife sciences research and other critical bioanalytical applications would strongly benefit from faster and higher resolution high performance liquid chromatographicHPLCseparations of larger molecules including proteinspeptidesglycopeptidesand glycansProteins therapeutics are complex moleculessusceptible to intended or unintended alterations of composition and conformationMany therapeutic proteins are inherently a mixture of closely related variantsCurrent practice is to employ HPLC to resolve and quantify the components such protein mixturesto assure identity and safety of the protein drugMany HPLC separations of proteins are limited in resolution of protein mixturesrequire an hour or moreand may not completely resolve all of the componentsDue to the complexity of samplesthere are many examples in the current research literature that combine multiple HPLC analyses to gain full details on protein compositionand to measure the levels of protein variantsboth during development of the drugas well as manufacture and quality assurance quality controlRegardless of the intended use of the quantitative informationhigh efficiency LC separations are a fundamental part of the analytical systemsand the time to achieve high resolution separations of protein samples is a great bottleneckThis proposal describes an approach to improve the separation efficiency of HPLC for protein analysis by extending the use of novel superficially porous particleSPPtechnologies to larger pore size column packing materials of smaller size particleswith optimized characteristicsproviding significantly faster and higher resolution separations of proteinsOur objectives are to createm diameter and smaller SPP silica particlesoptimize their materials propertiesand to load these materials efficiently into HPLC column formatsThe proposed work will extended recent breakthroughs in material science that yield authentic improvements in current materialsseeking to employ the technology in additional modes of HPLC operationincluding hydrophobic interactionion exchangeand hydrophilic interactionThe goals of the proposed work would yield very high performance chromatographic productsgreater than those currently availableto be applied broadly in analysis of proteinsparticularly for protein therapeuticsThe application of the technology is not limited to biopharmaceutical preparationsandin factwould benefit any current application that uses HPLC methods for larger biological molecule analysesThe separations technology described will directly lead to useful products for which there is a significant technical and market demand NarrativeHigh pressure liquid chromatography is the most widely used analytical method to separate mixtures of moleculesallowing measurement of quantities and identities of materials in a sampleThis method is broadly used in biomedical researchas well as in the creationmanufacture and control of therapeutic interventionsThe current proposal is to use new knowledge in materials science and chemistry to enable faster and more efficient separations by liquid chromatographysaving time and moneyas well as enabling new uses of the method to understand the structure and function of biological molecules