AlphaVax has completed process development and preclinical immunogenicity studies of its H1N1 (swine) influenza vaccine and will manufacture clinical trial material by the end of the month.
The vaccine has shown good production yields as well as excellent immunogenicity, even after just a single inoculation, said the company.
The company said that the design of future clinical trials of this vaccine will be based on two previous successful influenza vaccine trials run by AlphaVax, one carried out in healthy young adults and the other in an elderly population.
Andrew Graham, vice president for Development and Technical Operations at AlphaVax, said: “AlphaVax will begin GMP-compliant manufacturing of this vaccine for clinical testing next week, which is less than three full months from our initial receipt of the gene sequence from the WHO.
We are currently scaling up the process used to manufacture VRP vaccines and anticipate yields up to 1 million doses of pandemic influenza vaccine per lot at the 1,000 L bioreactor scale. Since the process is performed predominantly in disposable equipment, the design, construction and validation of a facility leading to the production of product for the market would be 1-2 years less than for a typical vaccine manufacturing facility.”