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Virology Research Journal
Volume 1 Issue 4 Vaccines World 2017
Notes:
Page 22
November 09-10, 2017 Vienna, Austria
21st World Congress and Exhibition on
VACCINES, VACCINATION & IMMUNIZATION
Development of a production and purification
platform for virus like particles (VLP) and
adenovirus vector vaccine candidates: Two case
studies
Youness Cherradi
Merck Life Science, Process Solutions, Belgium
Case Study 1: Virus-Like Particles (VLP) have received
increased attention following their success with marketed
vaccines. Whilst clinical candidates have proven efficacy and
protection, their large-scale production implies high titer
production, high recovery and purity leading to constant
process improvement to meet market demand. In this study,
a Hepatitis C Virus VLP based vaccine candidate production
and purification was evaluated in collaboration with Instituto
de Biologia Experimental e Tecnologica (IBET), Portugal. The
VLP vaccine candidate was produced in insect cell expression
system in a disposable bioreactor technology and cell culture
attributes were compared with those from glass stirred tank
bioreactor culture. Both systems harvests were subsequently
purified to assess the impact of upstream processing on the
downstream and the product quality. The downstream train
was improved through the selection of appropriate anion
exchange resin to reach 70% recovery and a satisfactory
Baculovirus log reduction. In addition, appropriate depth
filtration and ultrafiltration technologies were assessed and
selected. Altogether, this case study lays the foundation
for a fully GMP production process that can be easily pilot
transferred and implemented for clinical and subsequent
commercial production of VLP vaccine candidates.
Case Study 2: Adenoviral vectors (AV) offer a promising
new approach to vaccine development due to their easy
transgenic coding manipulation, efficient infection of various
mammalian cell types and the broad immune response
against the target antigen in vaccine recipients. Furthermore,
these vectors are known to offer excellent safety profile,
in that they can be engineered to be non-replicating in the
vaccine recipient and they lack the molecular mechanism for
integration into the host genome. AV’s are highly amenable
to scalable manufacturing processes such as the use of
stirred tank bioreactors, high capacity filtration methods,
and chromatographic purification procedures. GenVec and
Merck have collaborated to evaluate different technologies for
potential use in Adenoviral vector (AV) vaccine production.
We will present the filter options evaluated on GenVec’s AV
product candidates, along with the results and filter sizing
estimates for the process steps of medium exchange, lysate
clarification, post-clarification filtration, concentration/
diafiltration, and post-hold sterile filtration prior to column
chromatography.
Biography
Youness Cherradi, PhD is a Process Development Scientist for Merck in
EMEA since 2013. He is responsible for customer process development
and optimization on various downstream technologies and recently took the
responsibility of Global Lead for the Vaccine Process Development team
at Merck. He completed Master’s Degree in BioEngineering, specializing
in Chemical Engineering, Biotechnologies and Applied Genetics from the
Université Libre de Bruxelles (ULB, Belgium) as well as a PhD in Molecular
Bacteriology from the Medicine Faculty of ULB where he worked and published
on virulence mechanisms of Type-3 Secretions Systems.
Youness Cherradi, Virol Res J 2017, 1:4