In the Fight Against a Possible Flu Pandemic, Humanity Has a New Tool

Novartis Behring AG announced on October 2 the opening of a new plant in Marburg, Germany, dedicated to the production of influenza vaccines. It is the first plant worldwide to utilize the cell-culture method in the influenza vaccine production, which will greatly speed up the creation and readiness of influenza vaccines. This is a great step towards the preparedness for a global flu pandemic, which might kill millions of humans worldwide. Novartis is in the process of building such plants in other countries as well, including Holly Springs, North Carolina.

Traditionally, the production of flu vaccines is a lengthy and tedious process, which heavily relies on fertilized chicken eggs. Each egg only provides enough material for one dose of the flu vaccine. It usually takes about six months to produce the influenza vaccine, which is mostly due to the tedious production method as well as the limited supply of eggs suitable for use in the vaccine production process. Additionally, since each egg has to be treated by hand, the risk of contamination is increased.

The Novartis plant utilizes the cell-culture-method to produce the influenza vaccine. This method does not use eggs, but the cells extracted about fifty years ago from the kidney of a single cocker spaniel. The time it takes to grow the virus in these cells is about the same as it takes to grow the virus inside a chicken egg. However, the dog's cells are readily available. The cell cultures can be frozen, and if needed they can be limitlessly reproduced. Furthermore, they are ideal hosts for the influenza virus.

The dog's cells are propagated in three fermenters. In the next phase, the cells are infected with the flu virus. Once the virus has been successfully passed into the cells, the virus is inactivated and readied for distribution. The process lasts only thirty days, during which one milliliter of original cell substance is turned into 10 liters of influenza vaccine. The production process takes place in a closed reactor setting, which decreases the risk of contamination especially compared to the egg-derived vaccine production. Novartis expects to produce about 40 million influenza vaccine doses annually at this particular plant.

Since the dog cells are readily available and easily propagated, the start-up time for the vaccine production is shorter. This is especially of advantage, if the virus mutates quickly because vaccine changes can be implemented more quickly.

The new cell-culture-derived influenza vaccine production can be crucial in a global pandemic caused by the mutation of the H5N1 virus, the bird flu virus. This is especially true, if the virus would manage to wipe out the poultry population first as there would be hardly any eggs on hand to create a vaccine.The new vaccine is supposed to be called Optaflu. However, no delivery date for the vaccine has been set, because final regulatory approvals are needed.