Haynes: Protein Production Facility
The Protein Production Facility at the Duke Human Vaccine Institute (DHVI) is equipped to produce, at cost, HIV-1 Env proteins for the field to study, as standardized, quality in vitro reagents. The hope is that these reagents will both optimize clinical trial immune monitoring as well as facilitate Env immunogen discovery. The proteins produced in the Protein Production Facility are not intended for use in humans or clinical trials. All proteins will be produced under "GxP" best practices, which encompass applicable elements of GMP, GCLP, and GLP. GMP/GLP status is not claimed, but the facility will operate on the principles and processes established for GMP/GLP facilities in that procedures, equipment, operator training, and documentation will be governed by Standard Operating Procedures with oversight by Duke's CFAR Central Quality Assurance (QA) Unit. Documentation of all procedures is retained, and the facility is monitored for compliance to ensure consistent, reproducible, auditable, and reliable results and products are delivered.
The facility produces and purifies Env proteins, as well as performing QC tests on the Env proteins. All products are tested for bioburden (endotoxin, sterility, and mycoplasma) and undergo partial sequence confirmation analysis. All protein characterization, bioburden, and QC results are reported on the certificate of analysis upon delivery.