Characterisation of Biologics and Biopharmaceuticals

Ensuring the quality and safety of biopharmaceuticals (or biologics) is critical to their regulatory acceptance. Time-Domain NMR (TD-NMR) is one of very few analytical techniques with the potential to measure products in their original packaging from manufacturing through the supply/cold chain to the point of care.

TD-NMR uses the water signal, often treated as an interference by many spectroscopic techniques but abundant in many biopharmaceuticals, to indirectly measure concentration, aggregation or other states of proteins which relate to:

• Dosage
• Fluid volumes in vials
• Stability/separation
• Uneven filling, sedimentation and resuspension
• Effect of freeze-thawing

Related Papers

• A nondestructive and noninvasive method to determine water content in lyophilized proteins using low-field time-domain NMR
• Rapid and Noninvasive Quantification of Capsid Gene Filling Level Using Water Proton Nuclear Magnetic Resonance
• Magnetic Resonance Relaxometry for Determination of Protein Concentration and Aggregation
• Quality assurance at the point-of-care: Noninvasively detecting vaccine freezing variability using water proton NMR