Joseph G. Montalto

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A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media Supplement

A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media Supplement

Mary D. Whiteman;Gail Sofer;Joseph G. Montalto
September 1st 2003

Biopharmaceuticals are perceived as being at risk of transmitting spongiform encephalopathies to patients, although there has never been such an incident. Clearance studies such as the one described in this article (using a TSE model) can validate inactivation and enhance confidence in the safety of therapeutics produced using animal-derived cell culture supplements.

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