期刊
BIOPROCESS ENGINEERING
卷 23, 期 5, 页码 439-449出版社
SPRINGER-VERLAG
DOI: 10.1007/s004499900157
关键词
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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. VAQTA(R) 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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