sole_source_justification.docx

Sole Source Justification for iRepertoire, Inc. Conjugates

LMIV conduct basic research on malaria pathogenesis and immunology, with an emphasis on studies in humans who are naturally or experimentally infected with malaria parasites. In parallel, the Vaccine Development Unit— which was launched in 2001 as the Malaria Vaccine Development Unit and then became the Malaria Vaccine Development Branch before taking its current shape—operates more like a small biotech firm than a typical research laboratory. Specialists in each step of the development process, from antigen selection to clinical trials, contribute their expertise as the candidate moves along the development pathway. This allows multiple vaccine candidates to move from concept to clinical trials efficiently and rapidly. Together, the discovery sections and Production Unit form a research and testing enterprise that can rapidly translate ideas into proof of concept trials and then capture basic information about human immunity and responses to infection during human clinical trials. The Molecular Pathogenesis and Biomarkers Unit within LMIV apply functional genomics and molecular immunoparasitology computational tools to better understand the malaria disease as it relates to naturally exposed people living in Africa. One of the primary missions of the NIH is to publish new research discoveries from the laboratory and field studies to share what our research has shown.

LMIV Vaccine Development Unit develops and performs clinical evaluation of prototype malaria vaccines. Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, formulation, quality control, preclinical testing, and clinical trials. We would like iRepertoire to perform characterization of B cell receptors generated in response to vaccination with Pfs230 malaria transmission blocking vaccine in Malian adults using their novel, patented multiplex PCR technology (Patent No 7,999,092) that uses hundreds of specific primers in a single reaction that can semi-quantitatively and inclusively amplify all of the expressed sequences found in B and T cells from a single sample.