A New HPLC Immunoaffinity Assay for Intact Hepatitis A Virus: Applications in Vaccine Process Development |
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| Authors: | R Aboud A Hagen C Oliver R Sitrin |
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| Institution: | (1) Bioprocess and Bioanalytical Research Department, Merck Research Laboratories, P.O. Box 4, West Point, PA, 19486-0004, U.S.A |
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| Abstract: | An 8 minute HPLC immunoaffinity assay for hepatitis A intact virus (HAV) was developed using an activated aldehyde perfusive support and a purified monoclonal antibody. The assay is linear, reproducible, and sensitive for the evaluation of HAV in crude process streams over the range of 0.35 to 3.8 g of HAV injected. It presents an attractive alternative to ELISA methods for process monitoring applications. |
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