New Opportunities: Biomolecule Production Laboratory

点击翻译按钮获取中文摘要

The Biological Molecule Production Core Facility (BMPCF) will provide a key infrastructural component (Core D) for New England Regional Center of Excellence in BioDefense (NERCE). The BMPCF will consist of a state-of the-art laboratory whose mission will be the large scale production and purification of molecules of biodefense importance including proteins, toxin subunits, antigenic peptides, carbohydrates and other biologics. The molecules selected for production and purification will be those found to be important to the mission of NERCE and thus will include vaccine components, therapeutics, and antigens for immunoassay and diagnostics. The BMPCF will have the capacity to produce proteins in bacterial, yeast, insect cell, and mammalian cell expression systems. The core will operate under Good Laboratory Practice guidelines, so that the manufacturing protocols for each biological molecule will be appropriate for inclusion into Investigational New Drug applications, as necessary. The BMPCF will be capable of producing biological molecules in sufficient quantity and purity that they could be used for preclinical as well as early Phase I clinical trials. Thus, the BMPCF is intended to provide translational capacity to bridge the gap between the research laboratory and large-scale commercial production. The BMPCF core will be administered by two senior scientists that have 29 years of collective experience in the production of immunogens for Phase I human testing. All NERCE investigators and investigators throughout Region I working on federally supported biodefense projects will have access to the services of the BMPCF. The BMPCF will also work closely with other NERCE cores such as the Proteomics, Small Molecule Testing, and Administration to assure that adequate amounts of the rate-limiting biologics are available to support all relevant NERCE research and developmental projects. The facility will also be planned to allow its rapidly retooling for targeted new efforts in the event of a national biodefense emergency as determined by consultation with NIAID.