Nicholas Warne, Ph.D.

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
Trends in Lyophilization: Review of the Recent Lyophilization Conference on Ensuring Optimum Formulations for Biologics
Monday, March 01, 2010
I recently had the privilege of chairing the 3rd Annual Lyophilization Conference held February 25-26 in Boston, MA. The conference was well organized and offered thoughtful insights for attendees who were relatively new to ... read more

Articles by Nicholas Warne, Ph.D.