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.