"I think in general, one could always overthink ECs. Nonetheless, in earlier phases with little prior knowledge, effort is needed to set up ECs. It is the key question for the company whether at this stage ECs will provide a good ROI. I do not think this is a critical question in earlier phases and would focus on fit for purpose method to support proof of concept."

Learn more from Dr. Lars Geurink by viewing his presentation "Analytical Procedure Control Strategy (ACPS)" during the Expert Forum: Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development

The use of EC, or rather avoiding that the ECs are not too extensive, is not related to the modality, I think, but rather the amount of knowledge. It is a given that there is currently little prior knowledge for certain methods for cell and gene therapy, but it is the case for other methods, like multi-attribute methods.

Join Dr. Cyrille Chéry (UCB) to learn more about Critical Analytical Procedure Parameters and Risk Assessments.

Watch the On-Demand presentation now: https://bio-qc.com/critical-analytical-procedure-parameters-and-risk-assessments/  

Plus, don’t miss his expert insights during the panel discussion on Overcoming key challenges in understanding and implementing guideline ICH Q14 for Analytical Procedure Development.