Protein concentration is one of the critical quality attributes of fill-finished drug products, as it ultimately defines the dosage a patient receives. Process analytical tools are key in monitoring this attribute and are used to control the manufacturing process accordingly. This presentation will give an overview of the journey from initial laboratory feasibility tests of the CTech FlowVPE technology to implementation into an aseptic GMP facility for in-process control testing of biologics. In addition, the talk will highlight how the inline technology sheds new light on the manufacturing process and increases product understanding. Building on the availability of real-time continuous protein concentration data, next steps in the development and implementation of a future automated human-free process execution will be shared.

Speaker: Raf De Dier, Associate Director Advanced Technology – Janssen.