Control Strategy – Meaningful Attributes, Process Characterization and Appropriate Assays

The maturing of Cell and Gene Therapy products provides an opportunity to serve patients with options for treatment where none have previously existed. In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU. The number of products in clinical development in the US continues to increase and many of these products have potential for accelerated regulatory pathways. Manufacturers of cell and gene therapy products must tackle technological challenges under the pressure of short timelines resulting from streamlined clinical development. This session will focus on the key hurdles facing CMC professionals as product development programs move the into the later stages of process development and scale-up. How do we build a robust control strategy that is meaningful, sustainable and able to support the demonstration of process consistency as programs move through to commercialization.