Project 3 is an integral part of our IPCAVD Program grant. We propose to produce cGMP grade Env immunogens (two) that will be evaluated clinically in a Phase I trial by the HIV Vaccine Trials Network. Our commerical partner in the GMP-production of our Env immunogens is ABL, Inc. (ABL). We developed a plan that ensures the most efficient transfer of materials and 'know how' In Env expression, purification and characterization (antigenicaily and immunogenically) from the Stamatatos lab to ABL. The Stamatatos lab and ABL will be In continuous communication to ensure the rapid resolution of any issues that may arise. The Stamatatos lab will verify and ensure that all Env-related products (intermediate and final) generated by ABL meet the required antigenic and immunogenic criteria our immunogens must meet before their clinical testing.The proposed strategy for the production of Env immunogens is based on the expertise of the Stamatatos lab in Env expression, purificaiton and characterization with ABL's expertise in large scale GMP manufacturing of proteins/drugs, including recombinant Env proteins.
NIH ExPorter
NIH ExPorter