cGMP processing of a plant-produced human vaccine candidate for sexually transmitted infections

Qiang Chen, Gary Morris, Huafang Lai

Research output: Chapter in Book/Report/Conference proceedingConference contribution

1 Scopus citations

Abstract

Plants have been extensively investigated for producing human vaccines. However, due to remaining challenges, particularly in the area of upstream and downstream processing, there are still no licensed plant-produced human vaccine products on the market. This research aims to optimize a more scalable, cost-effective, robust, and safer production process for a vaccine candidate that prevents a variety of sexually transmitted infections. We investigated the parameters for transgene bank establishment, efficient biomass production, protein extraction, and product purification. We also studied the stability of the vaccine candidate under various conditions and established a set of analytical assays for characterizing in-process samples as well as the final purified product. The challenges in eliminating endotoxin and addressing compliance with FDA's current Good Manufacturing Practice (cGMP) regulations will also be discussed.

Original languageEnglish (US)
Title of host publicationAmerican Society of Agricultural and Biological Engineers Annual International Meeting 2009, ASABE 2009
Pages468-473
Number of pages6
StatePublished - Dec 1 2009
EventAmerican Society of Agricultural and Biological Engineers Annual International Meeting 2009 - Reno, NV, United States
Duration: Jun 21 2009Jun 24 2009

Publication series

NameAmerican Society of Agricultural and Biological Engineers Annual International Meeting 2009, ASABE 2009
Volume1

Other

OtherAmerican Society of Agricultural and Biological Engineers Annual International Meeting 2009
Country/TerritoryUnited States
CityReno, NV
Period6/21/096/24/09

Keywords

  • CGMP
  • Down-stream
  • Large-scale
  • Processing
  • Purification
  • Vaccine

ASJC Scopus subject areas

  • General Agricultural and Biological Sciences

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