Development of a Single Stage Dual-Ligand Monolithic Chromatography for Plasmid Based Vaccine Production

Wednesday, November 10, 2010
Hall 1 (Salt Palace Convention Center)
Clarence M. Ongkudon, Chemical Engineering, Monash University, Clayton, Australia and Michael K. Danquah, Bio-Engineering Laboratory, Chemical Engineering Department, Monash University, Melbourne, Victoria, Australia

Many of the production schemes employed by cGMP and GCP facilities combined at least three purification steps to achieve a pharmaceutical grade pDNA vaccine. Increasing the number of unit operations results in product loss and cost ineffectiveness. Although the concept of single-stage pDNA vaccine purification has been found to effectively separate supercoiled pDNA, many problems are still encountered such as low purity, low recovery, high salt consumption, need for post-treatment of pDNA vaccine, and instability of biological-based resin in high affinity separation thus making this process not commercially viable. The present work involves a novel process for pDNA measles vaccine production via optimum fed-batch bacterial fermentation and a single-stage chromatographic purification. Current single-stage chromatography involves only one type of chromatographic mechanism (e.g. anion exchange or affinity interaction) in a one-step loading, washing and elution. The chromatographic technology that is developed in this research is based on a dual-ligand monolithic column that exploits different ligand chemistries in a single column whilst keeping the concept of a single-stage process. The complete details of the invention will be discussed in the full article.

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See more of this Session: Poster Session: Bioengineering
See more of this Group/Topical: Food, Pharmaceutical & Bioengineering Division