Companies Race to Apply Cell Culture to Swine Flu Vaccines
Although mammalian cell culture is the standard production platform for recombinant protein products and monoclonal antibodies, its adoption for influenza vaccine production has been slow, and all currently approved seasonal influenza vaccines are still produced in eggs. The current outbreak of the H1N1 swine flu, however, has renewed and accelerated interest in applying cell culture to influenza vaccine production.
Although mammalian cell culture is the standard production platform for recombinant protein products and monoclonal antibodies, its adoption for influenza vaccine production has been slow, and all currently approved seasonal influenza vaccines are still produced in eggs. The current outbreak of the H1N1 swine flu, however, has renewed and accelerated interest in applying cell culture to influenza vaccine production.
In one of the most recent moves to apply cell culture to flu vaccines, the University of Queensland (UQ, Brisbane, Australia) has produced the first Australian batch of a new candidate vaccine against the H1N1 swine flu virus, using baculovirus and insect-cell technology from the US firm Protein Sciences Corporation (Meriden, CT). The batches produced by UQ are only for research purposes, however, under a research agreement with Protein Sciences focused on improving manufacturing methods. Protein Sciences is using its cell culture platform for its seasonal flu vaccine, FluBlok, which is currently in Phase 3 clinical development. On June 23, the company was awarded a $35 million contract from the US government (the department of Health and Human Services) further develop the technology.
Other major players currently developing cell culture–based flu vaccines include Novartis (Basel, Switzerland) and Baxter (Deerfield, IL). Novartis has produced its first batch of a cell culture-based H1N1 vaccine and expects to begin clinical trials this month.
Baxter, in turn, has begun commercial manufacture of an H1N1 vaccine produced in Vero cells. The company received EMEA approval for a mock-up pandemic vaccine called Celvapan. The Celvapan licensure from the EMEA supports fast-track approval of a pandemic vaccine containing the H1N1 virus strain. The H1N1 vaccine will be submitted for approval after completion of initial manufacturing runs.
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