Journal Article

Perspectives on the Manufacture of Combination Vaccines

John R. Vose

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue Supplement_4, pages S334-S339
Published in print December 2001 | ISSN: 1058-4838
Published online December 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/322570
Perspectives on the Manufacture of Combination Vaccines

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Evolving regulatory requirements in the United States and Europe create major challenges for manufacturers tasked with production of vaccines that contain ⩾9 separate antigens capable of protecting against infectious diseases, such as diphtheria, tetanus, pertussis, polio, hepatitis B, and Haemophilus influenza b, in a single shot. This article describes 10 steps that can facilitate the process of licensing these complex vaccines. It also points out problems associated with the use of animal tests for the crucial step of potency testing for batch release caused by the inherent variability of such tests and the difficulties of interpreting their results.

Journal Article.  3053 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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