AGENDA Highlights: Join Us at the ESGCT

Join Us at the ESGCT Conference, Booth # 2 and Discover
How Pall Life Sciences Can Meet Your Needs!
AGENDA
Highlights:
October 23 @ 11.35
October 23 @ 18.30-20.00
October 23@ 18.30-20.00
Clinical trial services company showcase
Mrs. Pascale Berthet - Business Development Cell Culture Technologies Pall Life Sciences
Use of Xpansion as midsize bioreactor for the manufacture of viral vectors
Dr. Alain Schwenck, Bioproduction Director – Genethon
Large-Scale Clinical Grade Retroviral Vector Production using a Fixed-bed
Bioreactor
Dr. Isabelle Riviere, Co-Director, Gene Transfer Facility – MSKCC
October 23@ 18.30-20.00
October 25 @16.45-17.00
Virus Production with the iCELLis® Single-Use Bioreactor
Mrs. Pascale Berthet - Business Development Cell Culture Technologies Pall Life Sciences
High yield adenovirus production in fixed-bed bioreactor
Dr. Hanna Lesch - Product Development Manager – FinVectors
Posters:
Use of Xpansion as midsize bioreactor for the manufacture
of viral vectors
Speaker: Dr. Alain Schwenck, Bioproduction Director – GENETHON
October 23, 18.30-20.00 – poster # P097
Despite progresses made in R&D in the field of gene therapy, viral vector batches for clinical trials are
still largely manufactured by scaling-out the laboratory methods in classical multi-tray stacks (MTS).
In a more restrictive GMP environment this technology presents a number of disadvantages and risks
due to the huge amount of manipulations during the upstream process steps. It also rises the problem of
FTE costs when considering increase of batch size.
Xpansion is a compact 2D, low-shear stress and controlled bioreactor, fully operated in closed system
offering an alternative for production of viral vectors production. Its similarities with classical 2D multitray stacks allow for an easy transfer of methods for growing and transfecting cells at larger quantity.
In addition, control of culture variables such as pH and D.O. offers the possibility of further optimizing
transfection process.
The application described here demonstrates the successful transfer of HEK 293 culture, transfection
and viral vector production, from MTS to Xpansion technology. Comparable cell growth and viral vector
titers were obtained compared to MTS. The scalability of the process from XP10 (R&D scale) to XP200
scale (production scale) has also been demonstrated.
Finally, considerations on production costs are also exposed.
Virus Production with the iCELLis® Single-Use Bioreactor
Speaker: Mrs. Pascale Berthet, Business Development Cell Culture Technologies, Pall Life Sciences
October 23, 18.30-20.00 – poster P088
Viruses are used in several medical applications including vaccination and gene therapy. Many viruses
are produced in anchorage dependent cell lines (e.g. HEK293, VERO, MDBK, etc). The iCELLis bioreactor
from Pall LifeSciences is particularly effective for virus production. Adherent cells grow in a microfiber
fixed-bed providing up to 500m² of growth surface area in a small reactor volume. Environmental
conditions, combined with the large growth surface area in the iCELLis yields high cell productivity.
A number of viruses, including AAV, Lenti, Adeno, Vaccinia, Bovine Herpes, Paramyxo and Influenza, were
produced in iCELLis bioreactors using either transient transfection or infection. Processes were tested
using identical parameters in small scale iCELLis bioreactors as used for previous standard processes
(e.g. pH, DO, T, seeding density, etc). MDBK, HEK 293 and Vero cells were scaled up to 66, 133 m2
and 660 m2 (prototype) bioreactors respectively. Production of influenza, BHV and an undisclosed lytic
virus was scaled up to 20, 66 and 660 m2, respectively. Intracellular viruses were harvested in situ using
lysis buffer. Transfection efficiency was evaluated by flow cytometry. Virus productivity was evaluated by
various quantitation methods.
Good regulation and biomass growth was achieved for all cell lines tested. Lenti and AAV transfection
efficiency was comparable in iCELLis compared to control vessels. Specific virus productivities in the
small and large scale iCELLis bioreactors were also similar or better than that achieved in standard
processes. The technology can be considered as an efficient tool for the industrial scale production of viral
vectors.
Large-Scale Clinical Grade Retroviral Vector Production
using a Fixed-bed Bioreactor
Speaker: Dr. Isabelle Riviere, Co-Director, Gene Transfer Facility – MSKCC (Memorial Sloan Kettering
Cancer Center)
October 23, 18.30
High yield adenovirus production in fixed-bed bioreactor
Speaker: Mrs. Hanna Lesch - Product Development Manager – FinVectors
October 25, 16.45
iCELLis Nano fixed-bed bioreactor, composed of medical-grade polyester (PET) microfiber carriers
was evaluated for adenovirus type 5 production. Optimized process contains cell expansion step in
bioreactor, infection and harvest by chemical lysis inside the bioreactor. iCELLis Nano proved to be
efficient and up to up to 100 000 vp/ cell productivity (HPLC titer) was achieved.
Clinical trial services company showcase
Speaker: Mrs. Pascale Berthet, Business Development Cell Culture Technologies, Pall Life Sciences
October 23, 11.35
Xpansion® Bioreactor
The Xpansion Bioreactor is an efficient
solution for the production of large amount
of cells. The Xpansion design is based on
stacked plates, made from the same plastic
material as multiple-tray stacks for an easy
and straightforward transfer.
Hillex®
CT Microcarriers
Hillex CT microcarriers are animal proteinfree, and designed specifically for the
expansion of stem cells for cellular therapy
applications, and have the lowest particulate
content of any microcarrier available. Pall
SoloHill® microcarriers are designed to
support cell growth at a variety of scales:
from spinner flasks, to large scale stirred tank
bioreactors, and can be gamma irradiated for
greater bioburden reduction.
PadReactor™ Mini
Bioreactor
XRS 20 Bioreactor
System
The PadReactor Mini bioreactor is the
scaled-down version of the manufacturing
scale unit with a maximum working volume
of 13L. This new addition is the perfect
solution for feasibility studies, process
development and small production of
proteins, viruses and stem cells.
The XRS 20 Bioreactor System is a new
single-use bioreactor system with unique
agitation and control properties designed
for the cultivation of mammalian cells
in suspension culture under controlled
conditions and suitable for applications
ranging from general life sciences research
to seed train operations and full GMP
production at the 2 to 20 liter scale.
iCELLis® Bioreactor
The iCELLis® is a scalable line of
bioreactors combining the advantages of
single-use technologies with the benefits
of a fixed-bed system. By providing
up to 500m2– equivalent to 3000 Roller
Bottles - the iCELLis bioreactor offers a
simpler alternative for process efficiency
to multipletray stacks, roller bottles and
bioreactors with microbeads.
Micro-24
MicroReactor System
The Micro-24 MicroReactor system is
a compact solution for efficient cell line
evaluation and process development.
With options for a variety of culture
conditions including aerobic & anaerobic
microbial fermentation, mammalian &
insect cell culture, the Micro-24 System
offers the most flexible operating
conditions available.
Visit www.pall.com/main/life-sciences-markets.page for more information on our capabilities or
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Pall Life Sciences, 25 Harbor Park Drive, Port Washington, New York, USA 11050
Web: www.pall.com/biopharm | Tel: 1-516-484-5400

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