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概要

Analysis of Alternative Purification of Beta-Propiolactone Inactivated, Tangential Flow Filtration Concentrated Vero Cell Derived Rabies Vaccine

Jagannathan Selvaraj, Mani Kavaratty Raju and Vijayakumar Rajendran

Rabies virus is a single stranded negative sense RNA virus that belongs to the genus lyssavirus of the rhabdoviridae family which causes an acute disease of vertebrate animals. In the production of vaccines, purification plays a crucial role in the vaccine efficacy. Viral inactivation and removal steps are critical parts in mammalian cell culture derived biotechnology products. Regulatory agencies are concerned with the presence of endogenous or adventitious agent in the cell lines or raw materials employed to manufacture pharmaceuticals protein from cell culture. Due to this, numerous techniques are affianced in the downstream processing of viral vaccines manufacturing especially chromatography. Advances in vaccine manufacturing have created an increasing demand for large volumes of highly purified viral antigens. Cellufine sulfate Chromatography which has been used for other viral vaccines of both animal and human, was used in this study for optimal recovery of valuable rabies viral protein and optimal removal of impurities such as residual cellular DNA and host cellular BSA successfully as a replacement of the existing zonal centrifuge method.

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