A recent study by Merck and the University of Maryland shows that water proton nuclear magnetic resonance (wNMR) can non-invasively analyze protein aggregation in prefilled syringes. This method can detect reversible and irreversible aggregation in high-concentration drug products, such as monoclonal antibodies. wNMR has benefits like simplicity, affordability, and potential point-of-care inspection. It can enhance pharmaceutical quality control and help with formulation work. Prior research has also shown its effectiveness in detecting protein aggregation and oxidative degradation. This technology has the potential to enhance drug safety and alleviate public mistrust. Before adopting wNMR, drug manufacturers should compare it with their current analytic technologies.
Introduction:
A recent study conducted by scientists at Merck and the University of Maryland demonstrates that water proton nuclear magnetic resonance (wNMR) can non-invasively analyze protein formulations in prefilled syringes. This technology provides a new method for evaluating the quality and stability of high-concentration protein formulations, such as monoclonal antibodies, without the need for dilution or transfer. The study shows that wNMR can detect protein aggregation and other quality attributes under various stress conditions, offering potential benefits for pharmaceutical quality control and pharmacovigilance efforts.
- Data collected from wNMR analysis can provide insights into the quality and safety of drug products, potentially leading to new concepts and paradigm shifts in drug development.
- The study used dupilumab, a high-concentration monoclonal antibody, to demonstrate the effectiveness of wNMR in confirming content uniformity, detecting reversible and irreversible aggregation, and assessing molecular association during freeze/thaw cycles.
- wNMR is a simple and affordable technology that does not require reagents or consumables, making it an attractive option for point-of-care inspection by healthcare providers.
- Prior research has shown that wNMR can detect protein aggregation and oxidative degradation in therapeutic monoclonal antibodies at high concentrations, making it a promising tool for process monitoring and product inspection.
- Implementing wNMR in pharmaceutical quality control can enhance preventive pharmacovigilance and address public mistrust of drugs and vaccines by ensuring their quality and safety.
Conclusion:
The use of water proton nuclear magnetic resonance (wNMR) offers a non-invasive and comprehensive method for analyzing protein formulations in prefilled syringes. This technology can provide valuable insights into the quality and stability of high-concentration protein formulations, helping to prevent drug shortages and improve pharmacovigilance efforts. wNMR’s simplicity, affordability, and potential for point-of-care inspection make it a promising tool for enhancing pharmaceutical quality control and addressing public mistrust of drugs and vaccines.
