Production Technology for Recombinant Intravenous Immunoglobulin

PROJECT SUMMARY Project TitleProduction Technology for Recombinant Intravenous Immunoglobulin OrganizationGigaGen IncPIDavid SJohnsonPh DIntravenous immunoglobulinor IVIgis a pool of antibodies isolated from the plasma of thousands of donorsIVIg therapy is used for several indicationsincluding B cell chronic lymphocytic leukemiaCLLautoimmune neuropathyand primary immunodeficiencyPIDIVIg sales are $billion worldwide and growing atper yeardue to an aging population and ever expanding therapeutic indicationsConventional methods for IVIg production threaten continued expansion of IVIg therapy because of supply chain riskimpuritiesand batch tobatch variationRecombinant IVIgor rIVIgcould solve all of the problems with the conventional plasma productHoweveruntil recently there has been no technology that could capture highly diverse native immune repertoires and recreate them in vitroIn our SBIR Phase Iwe used our GigaLinkmolecular genomics technology to build DNA libraries of natively paired Igand then express them in Chinese hamster ovaryCHOcells to produce the worldandapos s first rIVIg productIn our corresponding SBIR Phase II Renewalwe take steps to further develop the therapeutic product by building a library that meets FDA guidelinesscaling protein productionand benchmarking the product against conventional IVIgAfter completing this SBIR Phase IIwe will have sufficient data for a pre IND meeting with the FDA for the world s first recombinant IVIg drugThough PID will be the primary clinical indication for subsequent clinical studiesthe drug could eventually be used for other kinds of immunocompromised patientssuch as transplant recipientsFinallyour manufacturing approach could be used to combat emerging pathogensi efor West Nile rapid response PROJECT NARRATIVE Project TitleProduction Technology for Recombinant Intravenous Immunoglobulin OrganizationGigaGen IncPIDavid SJohnsonPh DIntravenous immunoglobulin is used to treat many kinds of immune disorders and is currently derived from pools of blood from thousands of donorsWe are building new technology that will allow us to manufacture intravenous immunoglobulin without donor blood