The landscape of Chemistry, Manufacturing, and Controls (CMC) is becoming increasingly intricate, driven by the rapid confluence of Industry 4.0 and the digital age, the rising demand for biology-centered therapies, and the necessity for business transformation. Traditional methods are no longer adequate to address the complexities of achieving "Compliance through Science" across pre-commercial, commercial, and post-commercial activities. A new approach to data acquisition and process understanding is essential.

This presentation directly addresses this challenge by showcasing the scientific potential and practical utility of a digitally empowered technology: SmartSkin Digital Container Twins. These "smart" replicas of vials, syringes, or cartridges create a unique signature of the product-equipment interface, generating measurable, transferable electronic data that directly correlates with processing parameters.

We will share compelling case studies demonstrating how this technology provides novel insights and agility for advancing products and processes through all validation stages (Stage 1, 2, and 3). Attendees will discover how Digital Container Twins can enhance process performance, simplify technology transfers, accelerate change management (DEV/CAPA), and ensure adherence to current and evolving regulatory standards for injectable products. This session offers a clear roadmap for increasing know-how and product quality in the digital era.