The Cell & Gene Therapy Manufacturing Pathway: Part 4

Supported by GE Healthcare

Innovation and Excellence in ATMP Manufacturing

PART 4: Latest advances in the analytical toolkit

GUEST EDITORS: Greg Russotti, Stephen Ward & Peter Zandstra

The move towards commercialization of cell and gene therapies invariably requires changes and modifications across multiple steps in the clinical-stage manufacturing pathway, in particular with the increasing need to move from manual to closed-system and automated processes. It is critical then that a manufacturer is equipped with the analytical tools to enable product comparability, quality control and de-risking the process changes inherent in moving to commercial scale manufacturing.