Case Study

"For emergency pandemic disease outbreak, single-use is the best solution to quickly produce vaccine to protect public health. During the outbreak of swine flu in 2009, TideCell proves its capability to promptly produce A(H1N1) influenza vaccine within three months."

In June 2009, the World Health Organization (WHO) declared the new strain of swine-origin H1N1 as a pandemic. This strain is often called swine flu by the public media. This novel virus spread worldwide and had caused about 17,000 deaths by the start of 2010. On August 10, 2010, the World Health Organization declared the H1N1 influenza pandemic over, saying worldwide flu activity had returned to typical seasonal patterns.  (cited from wikipedia)

TideCell operation for swine flu virus production in 2009 when the pandemic swine flue outbreak and becomes a global public health issue.

No.
Process Character
How TideCell supports the process requirement?
Can other systems do the same?
1.          1.
High cell density is required to achieve high virus titer.
High surface area provided in TideCell increase cell density. Cell density reach around 4 x106 cells/ml.
Roller bottle
The surface area is limited. Cell density reach around 0.5~1x106 cells/ml
Microcarrier stir tank
No. the bead density is limited. Cell density reach around 1~2x106 cells/ml
2.          2.
Cell attachment efficiency is low due to long term trypsinization.
A relative static seeding method enable high attachment rate even the cells have been over-trypsinized.
Roller bottle
A rolling culture status increase the difficulties of cell attachment, especially in serum-free culture medium.
Microcarrier stir tank
An agitation environment increases the difficulties of cell attachment. The cell attachment efficiency will become lower when the scale is increased.
3.          3.
Cells tend to detach after infection due to the adding of trypsin
A gentle and relative static culture method enables a low shear stress culture environment. Cells will be not easy to detach after infection and increase the productivity.
Roller bottle
An rolling culture environment enhance cell detach after infection.
Microcarrier stir tank
An agitated environment enhance cell detach after infection.
4.          4.
Low DNA and host cell protein is required
A gentle and relative static culture method enable a low shear stress culture environment. Cells are retained in the matrix without being flushing out. DNA and host cell protein reduces is relatively low in the harvest.
Roller bottle
An rolling agitated environment cause cell disruption and release of DNA and host cell protein directly into harvest.
Microcarrier stir tank
An agitated environment cause cell disruption and release of DNA and host cell protein directly into harvest.
5.          5.
Nutrient supply is crucial.  Medium exchange will dilute the virus titer.
Directly exchange culture medium from the mixing tank without interfere cells in the matrix vessel.
Roller bottle
Exchange culture medium directly from the bottle causing detach of cells.
Microcarrier stir tank
Culture has to be stop temperary and allow the microcarriers to settle before medium exchange.
6.          6.
Final Achievement
Virus HA titer: 512~1024
Roller Bottle
HA titer: 256
Microcarrier stir tank
HA titer: 256~512