Navigating the Frontier: Advances in monoclonal antibody purity control

Area of Science:

• Biochemistry
• Analytical Chemistry
• Biotechnology

Background:

• Monoclonal antibodies (mAbs) are critical therapeutics requiring stringent purity assessment.
• Traditional methods for mAb purity analysis have limitations in resolution and speed.
• Ensuring mAb integrity is vital for therapeutic efficacy and safety.

Purpose of the Study:

• To review advancements in separation techniques for monoclonal antibody (mAb) purity assessment.
• To highlight improved methods for impurity detection, identification, and quantification.
• To discuss the application of these techniques in mAb production and antibody-drug conjugate (ADC) analysis.

Main Methods:

• Exploration of traditional methods: SDS-PAGE, isoelectric focusing electrophoresis, size-exclusion chromatography.
• Analysis of advanced chromatographic techniques: various High-Performance Liquid Chromatography (HPLC) modes.
• Evaluation of capillary electrophoresis (CE) for mAb structural integrity and impurity profiling.

Main Results:

• Advanced techniques offer enhanced resolution, speed, and precision in impurity analysis.
• Innovations in chromatography, including superficially porous particles and novel stationary phases, overcome challenges like band broadening and adsorption.
• These methods are applicable to large-scale mAb production and antibody-drug conjugate (ADC) analysis.

Conclusions:

• Evolving separation techniques significantly improve mAb purity assessment.
• Advanced chromatographic and CE methods are essential for robust analysis of mAb products.
• Continued innovation in separation science is key to ensuring the quality of therapeutic antibodies.