Development, preparation, and testing of VAQTA (R), a highly purified hepatitis A vaccine

Manufacture of VAQTA(R), an inactivated hepatitis A vaccine, uses state-of- the-art technologies in cell culture and bioprocessing science, which have made it possible to routinely produce the vaccine at manufacturing scale. V AQTA(R) consists of an attenuated strain of hepatitis A virus that is highl y purified and formaldehyde-inactivated, then formulated with an aluminum h ydroxide adjuvant. Process development and scale-up have resulted in a well -characterized vaccine manufacturing process with appropriate in-process co ntrols to assure consistent performance, and a reproducible, well-defined p roduct. Results are presented from a series of manufacturing demonstration lots to show consistency, as well as comparability to clinical lots prepare d at an earlier stage in development.