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Monitoring bioactive and total antibody concentrations for continuous process control by surface plasmon resonance
Marlen Zschätzsch1, Paul Ritter2, Anja Henseleit1
1Institute of Natural Materials Technology Technische Universität Dresden Dresden Germany.
Engineering in Life Sciences
|July 7, 2020
Summary
Surface plasmon resonance spectroscopy offers a faster, label-free method for quantifying monoclonal antibodies during production. This biosensing technique enables efficient monitoring of both bioactive and total antibody concentrations, improving biopharmaceutical manufacturing processes.
Area of Science:
- Biotechnology
- Analytical Chemistry
- Biopharmaceutical Manufacturing
Background:
- Monoclonal antibodies are crucial in research and medicine, driving high demand in the biopharmaceutical sector.
- Industrial monoclonal antibody production requires large-scale, consistent, and highly productive processes adhering to strict safety guidelines.
- Current quantification methods like ELISA can be time-consuming; a need exists for faster, real-time monitoring techniques.
Purpose of the Study:
- To develop and validate a surface plasmon resonance (SPR) assay for monitoring bioactive and total monoclonal antibody concentrations in cell culture.
- To establish an efficient SPR-based quantification system as an alternative to ELISA for monoclonal antibody production.
- To analyze antibody production efficiency by comparing total and bioactive monoclonal antibody levels.
Main Methods:
- Development of an SPR assay using a target-monoclonal antibody model system.
- Identification of suitable target immobilization strategies for detecting bioactive monoclonal antibodies.
- Comparison of an adapted affinity method with standard amine coupling to improve the limit of detection.
Main Results:
- An adapted affinity immobilization strategy significantly decreased the limit of detection for monoclonal antibody quantification.
- The SPR system achieved a limit of detection in the low ng/mL range, comparable to ELISA.
- The method allows for the analysis of total versus bioactive monoclonal antibody concentrations, enabling assessment of production efficiency.
Conclusions:
- Surface plasmon resonance spectroscopy provides a viable, label-free alternative for monitoring monoclonal antibody production.
- The developed SPR assay offers advantages including low analyte volume, reduced assay time, and biosensor reusability.
- This method forms a foundation for developing SPR-based systems for continuous bioprocess monitoring.
