Dolores Baksh - Innovation Leader, Cell Therapy Technologies, GE Healthcare, USA
As patient specific, autologous cell therapies are in advanced clinical trial phases and are embarking on commercialization, there continues to be a need to have a robust, closed, automated and scalable manufacturing solution that can accommodate the processing of many patient samples in this growing patient population. What will be required is a means to process patient material in a fashion which maximizes the efficiency of the processing workflow for time and cost while meeting quality and regulatory requirements. This approach should retain the fundamental principles of preventing contamination, patient sample mixing, loss of identity or other events which interfere with the physical properties and integrity of the patient sample and final product. This talk will present details of what a manufacturing infrastructure needs to look like to take the above aspects into consideration and methodologies of how to achieve this infrastructure.