Comparability of Recombinant Proteins Subject to Process Change: A Regulatory Perspective

is being presented by Dr. Gavin Edwards, Senior Consultant, with ERA Consulting (UK) Ltd and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com

An inability to demonstrate product comparability following a process change is a common and serious error, however a well thought-out strategy for process change and the associated comparability exercise can ensure that regulatory pitfalls are avoided. In this audio conference, the speaker discusses the contents of ICH Q5E, using real-life examples to emphasize the main points. In addition, the presentation includes several case studies that illustrate the consequences resulting from a lack of comparability, for example, pure red cell aplasia associated with erythropoietin. Finally, the speaker also outlines procedures for seeking the advice of European regulators in relation to a process change.