In August 2012, the DHVI was awarded a grant by the Bill & Melinda Gates Foundation to establish a Protein Production Facility, which is directed by Kathy Yarborough, MS, with oversight from Barton Haynes, MD (Director of the Duke Human Vaccine Institute).
The facility is equipped to produce and purify, at cost via subcontract, HIV-1 Env proteins and antibodies as standardized in vitro reagents which can be used in HIV vaccine research. These reagents are intended to optimize clinical trial immune monitoring and facilitate Env immunogen discovery; however, the proteins are not intended for use in humans or in clinical trials. The production of all proteins and antibodies is governed by a Quality Management plan with oversight by the Quality Assurance for Duke Vaccine Immunogenicity Program (QADVIP), Duke’s Quality Assurance Unit. All proteins and antibodies are produced following Standard Operating Procedures (SOPs) and using Good Documentation Practices. Environmental monitoring of the laboratory space, freezers, refrigerators and incubators is maintained and recorded in compliance with PPF SOPs.
Quality-controlled protein production for Research Use Only:
DHVI PPF transiently transfects 293 or CHO mammalian cells with plasmids for recombinant expression. All proteins are run on SDS-Page and Western Blot for quality control analysis, and proteins that are not at least 85-90% pure are further purified.
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Nickel, lectin, protein A, and Kappa select purification methods are available.
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Recombinant Viral Envelope Proteins (250mL through 4 Liter Run Scale Production)
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Recombinant Immunoglobulin (Ab or Fab; 250mL through 4 Liter Run Scale Production)
Protein purification and Quality Testing
- FPLC-SEC Purification
- Sterility, endotoxin and mycoplasma testing available