ATR-FTIR Biosensors for Antibody Detection and Analysis

Area of Science:

• Pharmaceutical Science
• Biotechnology
• Analytical Chemistry

Background:

• Quality control is crucial for pharmaceutical products, especially complex biomolecules like therapeutic proteins.
• Bioprocess variations can significantly alter protein structure and impact drug quality.
• Monitoring critical quality attributes (CQAs) during production is essential.

Purpose of the Study:

• To develop a cost-effective and rapid biosensor for detecting immunoglobulins during biopharmaceutical production.
• To enable real-time monitoring of CQAs such as high-order structure and aggregation.
• To improve the quality control of biotherapeutic manufacturing.

Main Methods:

• Optimized reproducible grafting of 11-mercaptoundecanoic acid onto a germanium crystal.
• Developed an attenuated total reflection-Fourier transform infrared (ATR-FTIR) spectroscopy-based biosensor.
• Functionalized the germanium crystal surface with immunoglobulin-binding proteins for specific capture.

Main Results:

• Achieved highly reproducible grafting of the functional coating.
• Demonstrated the biosensor's ability to specifically bind immunoglobulins from complex media.
• Validated the biosensor as a tool for monitoring biotherapeutic production and assessing CQAs.

Conclusions:

• The developed biosensor is an easy-to-use, cost-effective, and time-saving tool for immunoglobulin detection.
• This biosensor facilitates the monitoring of biotherapeutic production and the assessment of critical quality attributes.
• It offers a powerful method for ensuring the safety, efficiency, and consistency of drug products.