Turbidity measurements expose heat‑induced instability in monoclonal antibody formulations

Monoclonal antibody (mAb) formulations are highly sensitive to temperature fluctuations. This study shows that turbidity measurements detect heat-induced changes in formulations, indicating structural alterations. Complementary refractive index data support compositional shifts, emphasizing the importance of monitoring mAb stability and ensuring cold-chain storage.

The three-dimensional structure of monoclonal antibodies (mAbs) in clinical formulations is crucial for their therapeutic efficacy, and so is storage at low temperatures, e.g. 4 °C.

In this study, the effect of thermal stress on the turbidity and refractive index of three mAbs batches was shown. These parameters can be used as QC parameters for batch control in pharmaceutical laboratories.

The results reveal significant effects of short-term storage at higher temperatures. The exposure to elevated temperature can cause e.g. partial protein unfolding or agglomeration. This is reflected in an increase in turbidity values and in a decrease of the refractive index due to changes in the particle – light interaction.

For the purpose of batch control, these optical parameters determined by Anton Paar instruments and measurement systems can be defined with dedicated limits. These limits allow continuous tracking of the clarity and stability of such antibody solutions.

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