The Chromatography Forum

of Delaware Valley

Talk 1 - Expanding the Biologics CMC Analytical Toolkit: Advances with PAT and 2D-LC

Douglas D. Richardson

Recent success in monoclonal antibody based immuno-oncology therapeutics such as Keytruda® have triggered a manufacturing revolution within the Biopharmaceutical industry. Preparation for a wave of immuno-modulatory receptor- focused clinical candidate’s, as well as novel protein modalities, highlights the need for a more flexible manufacturing and analytical testing network. This presentation will review progress for expanding the Biologics CMC Analytical Toolkit. Advances with Process Analytical Technology (PAT ) to support current and future protein manufacturing platforms will be reviewed. Additionally, progress with software and hardware for both instrument control and data analysis from 2D-LC method for characterization of complex samples such as clarified media, cell culture and therapeutic proteins including monoclonal antibodies (mAb’s) will be presented. Finally, a review of current analytical technology gaps and future opportunities for the Biologics CMC Analytical toolkit will be discussed.

Talk 2 - 2D-LC for the mainstream – industrial applications on synthetic polymers

Peilin Yang

There is a growing interest in two dimensional-liquid chromatography (2D-LC) in recent years. 2D-LC for a long time has been considered as a sophisticated tool for academic research. Recent advances in 2D-LC instrumentation and software led to a broader adoption of this technique in the industry. In this presentation, we will give a few examples of using 2D-LC in both heart- cutting and comprehensive mode with different combinations of separation mechanisms for various industrial applications, including using 2D-LC for quality control (QC) testing. Synthetic polymers will be the focus of this talk. Case studies will be presented on the characterization of synthetic polymers with comprehensive 2D-LC or quantification of small molecules in complex polymer matrices. Some practical considerations including polymer breakthrough, method robustness, fast method development, selection of column dimensions, and solvent consumption will be discussed. The limitation of the current technique and an outlook of future opportunities will be discussed at the end.