Isothermal Microcalorimetry for Pharmaceutical Stability Assessment

Conclusion: IMC stability measurements of biopharmaceuticals •Can detect denaturation/aggregation kinetics at temperatures below the Tm •Gives accurate stability assessment in 3-5 days, compared to weeks for storage tests •Provides sensitivity to detect heat signal in small volume (100 mg/mL) •Provides adequate sample throughput (1-48 samples) to assess multiple buffers and excipient conditions simultaneously •Can identify mAbs and their formulations that have best long-term stability much quicker then conventional methods •Measures rates of aggregation and therefore have the potential to predict time of storage while SEC, AUC and DLS measure the existence of aggregates after storage, while IMC

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