Integrated microreactor for enzymatic reaction automation: An easy step toward the quality control of monoclonal antibodies
Résumé
The main purpose of the present work is to provide a fully integrated miniaturized electrophoretic methodology in order to facilitate the quality control of monoclonal antibodies (mAbs). This methodology called D-PES, which stands for Diffusion-mediated Proteolysis combined with an Electrophoretic Separation, permits to perform subsequently mAb tryptic digestion and electrophoresis separation of proteolysis products in an automated manner. Tryptic digestion conditions were optimized regarding the influence of enzyme concentration and incubation time in order to achieve similar enzymatic digestion efficiency to that obtained with the classical methodology (off-line). Then, the optimization of electrophoretic separation conditions concerning the nature of background electrolyte (BGE), ionic strength and pH was realized. Successful and repeatable electrophoretic profiles of three mAbs digests (Trastuzumab, Infliximab and Tocilizumab), comparable to the off-line digestion profiles, were obtained demonstrating the feasibility and robustness of the proposed methodology. In summary, the use of the proposed and optimized in-line approach opens a new, fast and easy way for the quality control of mAbs.
Mots clés
Quality Control
Antibodies
Monoclonal
Humanized
Automation
Capillary electrophoresis
Chemistry
Pharmaceutical
Electrophoresis
Capillary
Enzymatic microreactor
Enzyme Assays
Hydrogen-Ion Concentration
In-line digestion
Monoclonal antibody
Osmolar Concentration
Proteolysis
Proteolysis product separation
Quality control
Trastuzumab