Oliver Graf, Novartis, TRD-Biologics Process R&D, Basel, Switzerland
Despite the large diversity in the biological properties of Biologicals (e.g. antibodies or antibody fragments) their physicochemical quality parameters can often be assessed by platform test methods. For typical parameters like the charge variant profile by ion-exchange chromatography, the size-variants by size exclusion chromatography (SEC) or capillary gel electrophoresis (CE-SDS) and even the profile of N-glycans it is common practice to apply generic platform methods. Such standardization of analytical testing of different Biologicals offers significant synergies. Repetitive hands-on operations like sample dilution steps and preparation of comparison solutions can be automated.
One of the cornerstones of this platform approach is to maximize the automation of processes which reduces analytical turn-around time and resources needed to support process development. The high throughput setup consists of robotic liquid handling workstation for sample preparation, high-throughput analytical instruments for fast sample analysis, data processor for collecting, parsing, editing and generating analytical data, a common database, and a web-based software application for user-friendly summary, visualization and interpretation of the final results.