Articles by Gail Sofer - BioPharm International

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Articles by Gail Sofer
Articles
VALIDATION: Advances in the Validation of Chromatographic Processes
February 2, 2007

ABSTRACT

Downstream Processing: Improving Productivity in Downstream Processing
November 1, 2006

Increased resin stability can extend the number of cleaning cycles that can be performed in situ.

A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media Supplement
September 1, 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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