GMP Twins: Making Digital Twins Real in GxP Manufacturing
Kevin Baughman
Vitaliy Kogut
Course Overview
Most discussions around digital twins in pharma focus on static or semi-live representations (digital models or digital shadows). True digital twins, however, are dynamic, interoperable systems that reflect and can anticipate real-time behavior across the production environment. This session explains what sets true digital twins apart and how they deliver value in regulated biopharma settings. We will cover the key distinctions between digital models, digital shadows, and true digital twins, and outline requirements for creating GMP‑compliant digital twins.
The role of interoperability, contextualized data, and real-time AI as core enablers of value will be explained, along with how digital twins are reshaping Continued Process Verification (CPV). The session presents CPV of the Future with findings from an Aizon‑led study using an AI‑driven fermentation twin and explores practical use cases such as predictive quality and deviation prevention, closed‑loop optimization with intelligent alerts, and scalable tech transfer for continuous improvement.
Watch now to discover what true digital twins entail in regulated industries like biopharma.