Qian Ruan
PaxVax Inc, USA
Title: Disposable and Scalable process for Chikungunya Virus-Like-Particle Production
Biography
Biography: Qian Ruan
Abstract
Chikungunya is a RNA alphavirus that causes arthralgia in its victims.It is spreading by its vector, Aedes aegypti mosquitos throughout the America’s, Asia and Africa.There is no vaccine currently available but a Virus-like-particles (VLP) based vaccine is one of the safest approaches as VLPs lack the genetic material to be infectious.Since VLPs usually adopt native conformation they can present proteins to the immune system much like infectious virus and elicit an efficient immunological response.
PaxVax has licensed the Chikungunya VLP vaccine developed by the Vaccine Research Center (VRC) at the National Institute of Health (NIH). Phase 1 clinical study for the CHIKV VLP vaccine has been completed by VRC and the results indicate that this vaccine is safe, immunogenic and well tolerated.
PaxVax CHIKV VLPs were derived by transient transfection of suspension HEK293 cells with purified plasmid [pCHIKVDNA (Strain 37997); encodes the structural genes of Chikungunya virus and is capable of replicating in E.coli]], further purified by ultrafiltration/diafiltration, anion exchange chromatography, filtration and aliquot into vials for injection.The presentation shows the challenges encountered for the CHIKV VLP transient transfection, scale-up in bioreactor and purification process development. Polyethylenimine (PEI, linear polymer, 25kDa) mediated chemical transit transfection and electroporation transient transfection were evaluated for the scalability and yield.The scalability of the transient transfection process and residual PEI concerns were addressed. Disposable and scalable processes are developed for further clinical development and FDA licensure.