In 2015, the DHVI embarked on an ambitious mission to plan, design and build a CGMP facility that would enable DHVI research teams to manufacture new vaccines for use in “proof of concept” experimental medicine Phase I clinical trials.
The facility, commissioned in 2016, houses state of-the-art equipment for the manufacture of recombinant Env immunogens and is operated by a dedicated GMP development and manufacturing team. The facility is supported by the Quality Assurance Unit to ensure that that all CGMP requirements are met for the manufacture and release of immunogens. Quality Unit is jointly managed by the Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP), and Robertson Clinical and Translational Cellular Therapy Quality Assurance (CT2 QA) teams.
Having a 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 advance our HIV vaccine development efforts, while having an infrastructure to respond to emerging public health threats.
For questions, contact GMP Program Manager Anna Fincher at firstname.lastname@example.org.
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