Serguei Tchessalov, Ph.D.

An Industry Perspective on the Application of Modeling to Lyophilization Process Scale up and Transfer
Thursday, March 16, 2017
While freeze-drying modeling is well established and documented, the extent of its application to routine operations, including development and manufacture, has not yet been fully realized. A survey, conducted by the BPOG ... read more
Quality-by-Design for Freeze-thaw of Biologics: Concepts and Application During Controlled Freeze and Thaw
Friday, July 01, 2011
This article, the second of two parts , continues the discussion of the application of Quality-by-Design (QbD) principles to freeze-thaw and storage of biologics drug substances. Specifically, we focus on the application of ... read more
Quality-by-Design for Freeze-Thaw of Biologics: Concepts and Application to Bottles of Drug Substance
Sunday, May 01, 2011
Biotechnology drug substances are often stored frozen. This approach has several advantages but is also expensive and time consuming. In the development of freeze-thaw processes for protein based products, we sought to ... read more

Articles by Serguei Tchessalov, Ph.D.