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Virology Research Journal
Volume 1 Issue 4 Vaccines World 2017
Notes:
Page 35
November 09-10, 2017 Vienna, Austria
21st World Congress and Exhibition on
VACCINES, VACCINATION & IMMUNIZATION
PATfixTM - At-line monitoring of impurities and
critical quality attributes in biopharmaceutical up-
and downstream processes using HPLC fingerprinting
Ingo Nagler, Aleš Štrancar1, Sebastijan Peljhan1, Tomas Kostelec1, Romina
Žabar1, Blaž Goričar1, Vid Skvarča1, Valentin Steinwandter3, Patrick
Sagmeister3 and Vignesh Rajamanickam2
BIA Separations, Slovenia
The most commonly used gene transfer vectors are
adeno- associated viruses, vaccinia viruses, adenoviruses,
lentiviruses, retroviruses and pDNA. Due to their large size and
sensitivity to pH, temperature and shear forces, purification
is challenging and time-consuming. Consequently a fast and
efficient downstream processing purification method is required
to isolate sufficient amounts of vectors with the final purity and
state that conforms to stringent regulatory demands. Convective
interaction media (CIM) monolithic columns provide a robust
platform for the purification of viral particles for vaccines and
gene therapy. Pores are replaced by large channels allowing
unrestricted flow of large biomolecules, eliminating diffusion
and allowing flow-independent resolution and dynamic binding
capacity. These properties, along with low back- pressure, lead
to higher purity, recovery and efficiency in the downstream
process. The poster presents multiple examples where monolithic
chromatographic column are used as capture or polishing step in
a process. Viruses (Adenovirus, Lentivirus), vaccines (Influenza
AH1N1) and pDNA are shown as case studies for their respective
downstream processes. The properties of monolithic columns
allow their use both as capture step where high flow rates are
required to capture and concentrate the particles, as well as
polishing. Characterized by very high resolving power, monoliths
can separate empty and full capsids of Adeno-associated virus
and discriminate between pDNA isoforms (supercoiled, linear,
open- circular).
Biography
BIA Separations is the leading developer and manufacturer of Convective
Interaction Media (CIM) monolithic columns for fast purification of biomolecules.
Our goal is to provide the best solutions in downstream processing and
analytics, with the goal of saving our customers valued time and costs during
the production of their desired biomolecules. We have over 20 years’ experience
in chromatographic purification of large biomolecules including viruses, VLPs,
phages, pDNA, antibodies (IgM, IgG), proteins, as well as removal of viral
particles, endotoxins and proteins from different biological matrices. We provide
products that range from small analytical columns to large industrial prep-
scale columns (including cGMP and disposable units in IEX, HIC, affinity and
customized formats) as well as method development services.
Ingo Nagler, Virol Res J 2017, 1:4