Solvay clears hurdle in cell-based flu vaccine supply
pharmafile | September 15, 2009 | News story | Manufacturing and Production |Â Â SolvayÂ
A manufacturing facility in the Netherlands operated by Solvay Biologicals has passed an inspection by Dutch authorities and is ready to start producing vaccines for influenza, including the H1N1 swine flu strain.
The Belgian drugmaker's facility in Weesp has been validated for producing vaccines in cell culture, a faster method than traditional techniques, which involve the use of embryonated chicken eggs.
Solvay already operates an egg facility for vaccines in Weesp, but says the new 3,900 sq.m. cell-based facility "will enable Solvay Pharmaceuticals to respond even better to the growing worldwide demand for influenza vaccines".
The egg facility is currently taken up with manufacturing seasonal influenza vaccinations, but later this month will be turned over to H1N1 vaccine production. Meanwhile, the cell facility has been making clinical batches of Solvay's candidate H1N1 vaccine for around a month.
Cell-based production of vaccine antigen can be implemented more quickly than conventional egg production, and has the advantage that it is not dependent on the availability of embryonated chicken eggs. It also offers an alternative to people allergic to chicken proteins.
The Dutch government has tapped rival drugmaker Novartis for supply of H1N1 vaccines, although last week it emerged the Swiss firm was lagging behind on promised delivery volumes. Solvay had bid for the contract but missed out because it was unable to meet the Netherlands' delivery objectives.
A statement issued by the country's health ministry a few days ago indicated that Novartis would supply less than 50% of its promised first delivery of 20 million doses, due in October.
Solvay is in the midst of feasibility studies for its own H1N1 vaccine candidate, and said: "further decisions on the development of pandemic influenza vaccines have not been taken at this point".
Future plans "will depend on different factors, including the results from the feasibility studies and future guidelines from health authorities", the Belgian company said in a statement.
Russian developments
Meanwhile, Solvay said it had been given a green light to sell the first trivalent adjuvant cell-based seasonal influenza vaccine – Grippol Neo – in Russia in time for the forthcoming 2009/10 flu season.
The product was developed for the Russian market alongside local pharmaceutical company Petrovax, which obtained the required production certificate and registration for the preservative-free vaccine.
Petrovax also contributed a proprietary adjuvant called Polyoxidonium that was used in the vaccine formulation.
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