Capillary electrophoresis for analytical platforms to enhance process monitoring

Abstract

Biopharmaceuticals, vaccines, and advanced therapies are becoming increasingly important in providing therapeutic solutions to patients. With the higher complexity and production costs associated to these therapies, efficient and safe bio-production is important to facilitate the implementation and use of biopharmaceuticals. 

In order to obtain efficient and safe bio-production, monitoring the upstream process is essential. Ideally, results are obtained immediately and critical process parameters adjusted accordingly. On-/at-line monitoring of the cell culture provides rapid information, replaces heavy-work load and time-consuming analyses, and reduces costs. All of these factors are critical for both process development as well as for manufacturing efficacy and robustness.

The iConsensus project aims at providing the pharmaceutical industry with such a monitoring system. The project’s goal is to achieve a safer, faster and more cost-effective process for the production of a wide range of biopharmaceuticals. Therefore, a platform of novel analytical tools for the monitoring of the upstream process is being developed. This includes the development of modular monitoring tools for real-time detection of physical factors, reagents and immunoglobulin G quality attributes in a bioreactor, a monitoring information database, modelling tools allowing efficient feedback control of the cultivation process, and new high-throughput production processes by high-performance parallel bioreactors.

A part of the analytical platform will consist of capillary electrophoresis applications for the analysis of monosaccharides, vitamins, lipids, amino acids, and the MAb aggregate quantity. For the purpose of automation, these capillary electrophoresis applications are preferably transferred to chip-sized CE. 

The presented posters showed the outline of the iConsensus project and some preliminary results of the ongoing method development for the saccharides and vitamins. 

Figure 1: APTS-derivatised saccharides analysed with chip-CE and LIF detection at 405 nm.

Figure 2: Standard vitamin mixture analysed with conventional capillary electrophoresis and UV detection at 197 nm.