HIV Envelope Manufacturing Workshop:
Case Studies and Lessons Learned
The Vaccine Research Program, Division of AIDS, NIAID and the Global Vaccine Enterprise held a 1.5-day workshop on June 11-12, 2015 at the NIAID Conference Center that addressed the current status of the complex technical hurdles related to the GMP manufacturing of HIV ENV proteins. This workshop was intended as a forum to exchange information and experiences that investigators have gained to date and to provide a status of ongoing efforts. A key objective of the workshop was to discuss and identify pathways and strategies that could accelerate or otherwise simplify efforts to introduce novel Env candidates into the clinic. Technical, programmatic and regulatory approaches were discussed.
The goals of the workshop were:
- To provide an update on the status of HIV Env antigens intended for clinical evaluation
- To exchange information and experiences encountered when transitioning from production of ENV proteins as research reagents to production as investigational clinical product
- To discuss and identify pathways and strategies for improving/developing a model for clinical manufacturing of Env proteins