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Baxter awarded UK pandemic flu contract

By Katrina Megget, 16-Aug-2007

Related topics: Processing & QC, Processing (automation, control, separation)

Baxter International's UK subsidiary has signed a contract with the UK Department of Health to provide an advanced supply of pandemic influenza vaccine.

The £155m ($308.8m) contract includes a similar advance supply deal between the Department of health and GlaxoSmithKline (GSK).

The breakdown of how much each pharmaceutical company has been awarded has not been disclosed. Likewise, the number of vaccine doses agreed to be supplied has not been disclosed.

Under the terms of the four-year contract with Baxter, the company would manufacture its pandemic vaccine in a serum-free, vero cell-based system at its vaccine facility in Bohumil, Czech Republic. The facility has the capacity to produce up to 100 million doses of pandemic vaccine annually.

Cell-based manufacturing procedures are being seen as hot favorites in the face of a potential threat of a pandemic as the vaccine manufacturing time can be cut from six months using traditional egg-based techniques, to just weeks.

Baxter's vero cell culture process, derived from green monkey kidney cells, can be initiated rapidly due to the use of a "native" virus (based on the exact pandemic strain identified) that does not need to be modified to allow growth in eggs. In this way vaccines can be produced in as little as 12 weeks.

The system has also shown to produce high yields.

Through the use of a native virus, there is no need to use an adjuvant because of the high natural immunogenicity provided.

A Phase I/II study in Europe showed subjects developed an antibody response at doses as low as 3.75 micrograms and substantial levels of cross immunity against widely divergent H5N1 strains.

"We are proud to provide the necessary technology, manufacturing capability and other resources to assist the Department of Health in its efforts to protect the UK population from the threat of a flu pandemic," Baxter vaccine business president Kim Bush said in a statement.

Baxter has recently completed enrollment for a Phase III trial for mock-up licensure in Europe.

Earlier this year the company was awarded a contract to supply pre-pandemic vaccine of the likely strain to the UK Department of Health and is working with agencies in the US to develop vero cell culture-based candidate pandemic and seasonal influenza vaccines in the US.

Also under the terms of the contract is an option for the Department of Health to purchase pandemic influenza vaccine in the event a pandemic is declared.

In regards to the GSK advance supply agreement, the UK drug giant has committed to make necessary preparations to supply its pandemic influenza vaccine as soon as possible after a pandemic outbreak has been declared.

The pandemic vaccine uses GSK's proprietary adjuvant system technology which has been shown to reduce the amount of antigen required for a seroprotective response. The vaccine has also shown in trials to induce cross-protection of different strains.

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