Industrialization Core: Production of monoclonal antibodies and product developm

$591,012U19FY2018AINIH

Scripps Research Institute, The, La Jolla CA

Investigators

Linked publications & trials

Paper 38979279 Paper 35890050 Paper 35745509 Paper 35303429 Paper 34715022 Paper 33852862 Paper 33852832 Paper 33536172 Paper 32269122 Paper 32142546 Paper 32023489 Paper 31401518 Paper 31398326 Paper 31312805 Paper 31301137 Paper 31104840 Paper 30996276 Paper 30886356 Paper 30884329 Paper 30836107 Paper 30833785 Paper 30728263 Paper 30629918 Paper 30629917 Paper 30541860 Paper 30333617 Paper 30333174 Paper 30206174 Paper 30203042 Paper 30184505 Paper 30096313 Paper 30092199 Paper 30029854 Paper 29982718 Paper 29982696 Paper 29940415 Paper 29889278 Paper 29878131 Paper 29872540 Paper 29843991 Paper 29736037 Paper 29720525 Paper 29511141 Paper 29500195 Paper 29369776 Paper 29324225 Paper 29194012 Paper 29153506 Paper 29148858 Paper 28890093 Paper 28869611 Paper 28822631 Paper 28572385 Paper 28545034 Paper 28539454 Paper 28525756 Paper 28525755 Paper 28402862 Paper 28381540 Paper 28356257 Paper 28181533 Paper 27786606 Paper 27608667 Paper 27588425 Paper 27587634 Paper 27586328 Paper 27562261 Paper 27402779 Paper 27368093 Paper 27335383 Paper 27187443 Paper 27161536 Paper 27160900 Paper 27111888 Paper 26962157 Paper 26912366 Paper 26826442 Paper 26806128 Paper 26758505 Paper 26468533 Paper 26276630 Paper 26232440 Paper 26115029 Paper 25984565 Paper 25723165 Paper 25723164 Paper 25609303 Paper 25569078 Paper 25531344 Paper 25404321 Paper 25353969 Paper 25171469 Paper 25140871

Abstract

Monoclonal antibodies (mAbs) have great potential to counter biological warfare agents that are not addressed by currently available countermeasures. mAbs display exquisite specificity, are able to recruit host immune components to fight infection, confer near-immediate immunity once administered, can be successfully administered to all populations regardless of current immune status, and have a generally low rate of adverse reactions. The Industrialization Core's main responsibility will be to lead the translational research effort for the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VHF-IC). The members of the Core have extensive experience with translating mAb research concepts into IND-enabling preclinical therapeutics for infectious diseases. The Core will make use of a rapid antibody manufacturing platform (RAMP) to provide well characterized, highly purified homogenous mAb preparations to facilitate direct comparisons between different mAbs by the individual Research Projects and Cores C and D. The Industrialization Core will be responsible for management of the advancement of products generated by the Research Projects through IND-enabling studies. In Specific Aim 1, to quickly and economically address the supply needs for the Research Projects and Structure and Virology Cores, the Industrialization Core will produce all ofthe VHF-IC mAbs using the RAMP Nicotiana benthamlana manufacturing system. The Industrialization Core will ensure that all Research Projects and Cores C and D are using well-characterized mAbs with homogenous mammalian N-glycoforms that are produced and purified using a single protocol. In Specific Aim 2, the Industrialization Core will be responsible for advancing the lead products selected from the three Research Projects by the Product Development Team through preclinical development.The Product Development Team will be responsible for prioritizing products and allocating Core resources appropriately and will work closely with the sponsoring companies (Mapp/Defyrus for filovirus products; Zaigen for arenavirus products) who will ultimately be responsible for developing the products after completion ofthe VHF-IC effort.

View original record on NIH RePORTER →