Critical Quality Attributes (CQAs): Know Their Importance & Limitations In Product & Process Development

By Katrina Adlerz

Mesenchymal stromal/stem cells (MSCs) can be a highly diverse modality. With variable tissue sourcing, bioproduction methods, formulations, route of administration, and patient monitoring, the myth that each Critical Quality Attribute (CQA) will be the same for every MSC clinical product has long been dispelled. In reality, some CQAs will be the same— and others will be very different. Our goal in this post is to outline what quality attributes may be similar across products and which will be different, as well as highlight the important differentiation of what is a Critical Quality Attribute vs a quality attribute.