Flu Vaccine Manufacturers Build on Manufacturing, Technology Base

A number of factors have been responsible for the change, according to Howard Pien, President and CEO of Chiron Corp. (Emeryville, Calif.), who testified on February 12 before the House of Representatives' Committee on Government Reform, in a hearing discussing flu vaccine supply and readiness for potential pandemics. For one thing, recommendations on immunizations have been broadened to include those between 50 and 64 years of age, and between 6 and 23 months. In addition, pricing of vaccines has increased and physician reimbursement rates have increased, encouraging more doctors to recommend immunization. The most dramatic trend, with the greatest implication for future supplies and products, is the move from egg-based to cell-culture-based manufacturing processes. Although the new cell-culture processes have not yet been approved for use in the U.S., some have been okayed in Europe, where the first commercial cell culture based vaccines are expected to be sold next year. The move from a manufacturing technology based on breeding flu antigen in fertilized hens eggs, then killing and purifying the virus to a cell-culture based process will allow capacity to be scaled up or down quickly, manufacturers say. In addition, cell-culture-based processes will shorten the time between identification of the year's flu virus strains and the rollout of vaccine. The new technology won't require adding proteins or raw materials of animal origin, and will result in a product free of egg protein, antibiotics or preservatives containing mercury, explained Gordon Busenbark, vice president of Baxter AG (Vienna) during a ceremony at a new, partially-completed facility in Austria last March. The world's leading manufacturers are moving to increase vaccine production capacity. In July, Chiron bought GSK's PowderJect Pharmaceuticals for $878 million. The company currently operates flu-vaccine manufacturing facilities in Liverpool, U.K. (Photo) and Marburg, Germany. Over the past five years, Pien said, Chiron