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Cell culture H1N1 vacc could be ready in 3 months

By Gareth Macdonald , 15-Jun-2009

 

Industry response to the H1N1 pandemic suggests that cell culture vaccine production is about to come of age with two firms that use the technique, Novartis and Baxter, claiming it will cut development and manufacturing timelines by months.

Last Thursday, June 11, World Health Organization (WHO) director general Margaret Chan officially declared the pandemic explaining that H1N1 infections worldwide can no longer be traced and that “further spread is considered inevitable.”

She asked drugmakers to begin preparing for large-scale H1N1 vaccine production when manufacture of seasonal stocks is completed, prompting a flurry of industry updates from vaccine producers.

Baxter and Novartis aim for early availability

The most eye-catching of these responses came from US drugmaker Baxter which announced it has completed testing of its Celvapan H1N1 vaccine and is “now in full-scale production,” and is working to deliver it as early as next month.

Traditionally, seasonal influenza vaccines are mass produced using the albumin found in fertilised hens eggs as a growth media.

While this method is effective, it does require several technology specific steps that delay manufacture.

In contrast, cell culture production technologies can be employed as soon as the seed stock virus is received, meaning that vaccine can be assessed by regulators and launched much sooner than those made using egg-culture methods.

Baxter explained that its Vero cell culture technology allowed it to complete development of the vaccine weeks ahead of its original schedule. The firm plans to submit its product for approval when manufacturing runs are completed.

Swiss drug major Novartis made similar claims for its cell culture developed vaccine, although it was more measured about its timelines.

Novartis said it completed making the first batch of a H1N1 vaccine weeks ahead of expectations, explaining that its culture system allows production to begin “without the need to adapt the virus strain to grow in eggs, as with traditional…technologies.”

The firm, which claims to have been asked to supply vaccine ingredients by more than 30 countries, said it will begin trials of its product next month and expects to obtain regulatory approval for the vaccine in the autumn.

In a follow up statement reported by London’s Financial Times yesterday, Novartis said that it “will not give free vaccines against H1N1 flu to poor countries, though it will consider discounts.”

GSK, Sanofi and CSL

The response of companies that use egg-based production methods was more uniform, with almost all saying that large-scale manufacture will begin by September at the earliest.

Initial media reports suggested that Australia’s CSL will finish making the first batch of its vaccine ahead of producers like GlaxoSmithKline (GSK) and Sanofi Aventis, although this was later denied by company spokesperson Rachel Davis.

She told in-PharmaTechnologist that while, in common with European drugmakers, development will take six months, “we anticipate that batches will be released in advance of this in Australia… as we are currently in winter and the flu is spreading rapidly.”

Davis also said that in contrast with media assertions about intra-industry rivalry to be first to make an effective vaccine and gain market advantage CSL “[doesn’t] consider this a race with competitors, it is a race to get the solution to the virus.”

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