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.
***Live: Thursday, Dec. 3, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET*** Review preclinical strategies to improve drug development outcomes for biologic drugs, including innovative solutions and risk-based approach to expedite investigational new drug submissions, especially for pandemic response initiatives.. ***On demand available after final airing until Dec. 3, 2021***