The Good Manufacturing Practice Facility consists of five manufacturing suites featuring state of-the-art single-use equipment for the manufacture of HIV antigens, mRNA therapies and vaccines, and other cell or bacterial-based products as required. The manufacturing capability is complimented by dedicated teams for cell line development, process development, analytical development and quality control, program management, quality assurance and regulatory teams. The facility is managed under a quality system to ensure that that all cGMP requirements are met for the manufacture and release of clinical products.
Having a Current Good Manufacturing Practices (cGMP) facility as part of the DHVI makes us one of the most globally advanced vaccine institutes in the country. It positions the DHVI teams to speed translational efforts moving research discoveries to impactful clinical trials, while having an infrastructure to respond to emerging public health threats.
The overall goal is to produce cGMP clinical trials materials for the CHAVD consortium in a cost-effective and timely manner. The GMP Production Unit will be responsible for pre-production, cGMP manufacturing and post-production quality control and stability assessment of CHAVD vaccine candidates to support their study in HIV Vaccine Trials Network (HVTN) Phase 1 clinical studies.