Novartis regulatory update

HHS said Novartis' cell culture influenza vaccine and adjuvant manufacturing facility in Holly Springs, N.C., is "pandemic ready." The facility, which was developed under a public-private partnership between HHS and Novartis' Novartis Vaccines and Diagnostics Inc. unit, is the first U.S. facility to use cell culture based technology to manufacture influenza vaccines. Novartis said the technology is better controlled and can be scaled up more quickly in response to a pandemic compared with the conventional egg-based process used to manufacture vaccines. The pharma also said the facility, which was designed to supply 150 million doses of pandemic vaccine within 6 months of an influenza pandemic declaration, will be able to produce up to 25% of the needed influenza vaccines for emergency use in the U.S. in the event of an influenza pandemic. Additionally, HHS said the cell-based technology at the facility may be adapted to produce vaccines for other infectious diseases in an emergency. ...