Core - Manufacturing

Volenec, Jerry

Abstract

Core B, the manufacturing core will develop, manufacture, Quality Control test and release of novel, peptide-based immunotherapeutic vaccines for stimulation of Cytotoxic T Lymphocyte (CTL) immunity in humans in AIDS treatment research.
The specific aims for this project are: 1) To contract the manufacture of purified peptides as defined in the research project in compliance with Good Manufacturing Practices (cGMPs); 2) To develop formulations of the peptides as required for the intended clinical studies as a sterile injectable; 3) To develop the analytical- methods and Quality Control specifications necessary for the comprehensive evaluation and disposition of manufactured drug products; 4) To develop the processes necessary manufacture the raw material peptides into final vial product in the defined formulations; 5) To conduct preclinical toxicologic evaluations of the final dosage forms to assure ifs safety prior to clinical evaluations; 6) To contract with an established fill/finish facility for the GMP vialing of the final vial product; 7) To file the requisite submissions with the FDA for evaluation and gain clearance for release of clinical supplies for clinical investigation; and 8) To conduct stability studies of manufactured drug product to assure that the product tested in the clinical studies continues to meet its release criteria throughout its period of use. Investigational New Drug (IND) and supporting submissions will be made to the FDA. All manufacture will be conducted in compliance with FDA regulations Good Manufacturing Practices (cGMPs).