Gail Sofer

Articles

VALIDATION: Advances in the Validation of Chromatographic Processes

ABSTRACT

Downstream Processing: Improving Productivity in Downstream Processing

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

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.

Part 1: Skin, Bone, and Cells

by Gail Sofer, BioReliance

Part 4: Culture Media, Biotechnology Products, and Vaccines

by Gail Sofer, BioReliance

Inactivation of Viruses: An Introduction to the Series

by Gail Sofer, BioReliance

Part 3b: Plasma and Plasma Products (Treatments Other than Heat or Solvent/Detergent)

by Gail Sofer, BioReliance

Part 6: Inactivation Methods Grouped by Virus

by Gail Sofer, BioReliance, Dorothy C. Lister, and Jeri Ann Boose

Part 3a: Plasma and Plasma Products (Heat and Solvent/Detergent Treatments)

by Gail Sofer, BioReliance

Part 5: Disinfection

by Gail Sofer, BioReliance