Articles by Gail Sofer - BioPharm International



Articles by Gail Sofer

VALIDATION: Advances in the Validation of Chromatographic Processes

Improvements in process validation approaches have resulted in better process understanding.
Feb 2, 2007


Downstream Processing: Improving Productivity in Downstream Processing

Nov 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

Sep 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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