Slip Flow Chromatography

DESCRIPTION provided by applicant The goal of this STTR Phase II collaboration between Purdue University and bioVidria Inc is to commercialize disruptive new technology for protein chromatography and then maximize its impact by serving the fastest growing segment of the pharmaceutical industry protein drugs The product is a reversed phase chromatography column that uses silica particles of only nm in diameter thereby significantly increasing resolution and sensitivity in protein separations Slip flow is what enables high flow rates with such small particles The primary market opportunity is the analysis of the heterogeneity of bioengineered drugs based on monoclonal antibodies These drugs offer high target specificity e g toxicity directed at the tumor The problem to be solved is that monoclonal antibodies can undergo intra and inter molecular disulfide scrambling during storage which causes immunogenicity in patients The proposed slip flow column will uniquely resolve and isolate these scrambled versions enabling rational design of formulations to reduce immunogenicity The Phase I research focused on protein and peptide separations in packed capillaries demonstrating ten fold narrower zones and a ten fold flow enhancement from slip flow The Phase II research will focus on scaling up to develop packed stainless steel columns of mm in diameter The scale up will allow customers to use these columns with current commercial instruments which is essential for serving the pharmaceutical industry The Specific Aims of the Phase II proposal are to optimize the process for packing nm particles into stainless steel columns develop a scalable process to make bonded phases with negligible silanol activity and develop separation methods for resolving products of disulfide rearrangement of monoclonal antibodies for all three types of antibody platforms We enlist three major companies to provide samples Genentech IgG Pfizer IgG and Eli Lilly IgG PUBLIC HEALTH RELEVANCE A new type of chromatography column will assist the pharmaceutical industry in reducing side effects of drugs to treat cancer and autoimmune diseases