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Development, preparation, and testing of VAQTA®, a highly purified hepatitis A vaccine |
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| Authors: | A Hagen J Aunins P DePhillips C B Oswald J P Hennessey Jr J Lewis M Armstrong C Oliver C Orella B Buckland R Sitrin |
| Institution: | Departments of Bioprocess and Bioanalytical Research, Merck Research Laboratories, West Point, PA 19486, USA, US Department of Cell Culture Development, Merck Research Laboratories, West Point, PA 19486, USA, US Bioanalytical Development, Merck Manufacturing Division, West Point, PA 19486, USA, US (Current address) MedImmune, Inc., Gaithersburg, MD 20878, USA, US Chemical Engineering R&D, Merck Research Laboratories, Rahway, NJ 07065-0900, USA, US Department of Bioprocess R&D, Merck Research Laboratories, West Point, PA 19486, USA, US |
| Abstract: | Manufacture of VAQTA®, 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. VAQTA® consists of an attenuated strain of hepatitis A virus that is highly purified and formaldehyde-inactivated, then formulated with an aluminum hydroxide adjuvant. Process development and scale-up have resulted in a well-characterized vaccine manufacturing process with appropriate in-process controls to assure consistent performance, and a reproducible, well-defined product. Results are presented from a series of manufacturing demonstration lots to show consistency, as well as comparability to clinical lots prepared at an earlier stage in development. |
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