CE-chip platform

One of the analytical technologies for the integrated panel (PAOLA) of iConsensus is capillary electrophoresis (CE). The aim of this part of the project is to develop the CE-chips, together with kits and methods, for integration in the PAOLA, to allow a robust and easy to use analytical tool for instant analysis.

Introduction

CE is a high-performance separation technique which allows identification of chemical constituents of wide range of analytes, from small ions to large biopolymers or even cells. As an analytical method CE is highly efficient, fast and has minimal (nL) sample consumption. It also requires very small amounts of reagents, which are usually environmentally friendly. Transferring methods for conventional CE to, and developing novel concepts for, CE-chips brings the additional advantages of CE-chips; their relatively small footprint, their ease of automation and integration, and even faster analysis. All this makes CE-chips with adapted reagents and methods ideal to integrate in a production environment. By using earlier established dynamic or permanent coating technologies for the separation channel, the developed kits will be reproducible and easy to use.

Figure: Schematics of conventional instrumentation, separation principle and electropherogram.

Figure: CE-chip (drawing from Micronit).

The CE-methods, including kits, and CE-chips developed will generally offer novel tools for fast analysis of a number of important substance groups (amino acids, sugars, lipids, vitamins, Mab aggregates) improving and simplifying analysis in many areas linked to bioanalysis and pharmaceutical production. More specifically this approach of at-line analysis for cell cultivation monitoring will offer efficient assessment of molecular factors crucial for optimal and high quality biopharmaceutical yield. The unique opportunities to control the cultivation process will in turn contribute to more precise, and time and cost effective production.

Workpackage objectives

To determine the user requirements for the analyses selected, including sample preparation like separation from cells and cell debris, and to gather these in Analytical Target Profiles, ATP, to facilitate expedient analysis
To determine the analytical possibilities for the use of CE for analysis of samples taken from the cell media and the cell cultures
To develop prototype CE chips and kits for analysis, and test these kits in the industrial labs. Current assumption is that setups for amino acids, lipids, vitamins, sugars, Mab aggregates and Mab charge variant species will be developed but other medium components and product quality attributes could also be of interest
To develop CE chips and analysis kits for integration into the iConsensus system

Workpackage achievements

Analytical targets specified for CE-chip platform

Capillary electrophoresis for analytical platforms to enhance process monitoring

Amino acid assay on CE chip

Development of an integrated capillary electrophoresis prototype

Leader and co-leader

Åsa Emmer, Analytical chemistry, KTH

Nienke Vriezen, Synthon

Partners

KTH

Kantisto BV

Micronit