Changes in production scale required due to increasing product needs throughout clinical trials introduces risk to the product development timeline. Both the process and the product can be dramatically impacted from scaling-up to larger production volumes. Once in commercial manufacturing, sudden changes to product demand in either direction can have costly consequences if the scale of production chosen is not adequate to meet the changing material requirements. Adapting a “scale-out” instead of “scale-up” strategy for clinical and commercial production can greatly minimize these risks. This podcast will review the scale-out biomanufacturing approach and the significant benefits of this production paradigm.