Therapeutic monoclonal antibodies are a clinically important and life-saving class of biotherapeutics used in the treatment of several previously intractable diseases. However, their development and manufacture presents many significant analytical challenges. The characterization of higher order structure (HOS) is of critical importance, since misfolding or aggregation of a biotherapeutic can lead to loss of efficacy or elicit unintended immune responses. NMR spectroscopy is well suited for such characterization given the ability to detect subtle changes in HOS. Here, we report a combined interlaboratory analysis of 1D and 2D methyl techniques, using linear correlation methods on a panel of mAb samples. Results suggest that the techniques are complimentary to each other, and are reproducible regardless of operator, laboratory and spectrometer field strength.
Research And Development
Medical Laboratory Technician25%
Manufacturer - Other15%