Concentration and temperature variations can have a significant impact on the viscosity when concentration of monoclonal antibody are formulated at 100 mg/ml or higher for less-frequent dosing injection.
Through this study, it was advised that, “to successfully manufacture high-concentration parenterals, manufacturers must understand the concentration-temperature-viscosity profile of their drug products. The profile can be determined with little effort and material using temperature controlled microviscometer."
In this article, the viscosity of high‑concentration MAb drug product, with a specification for protein concentrations and at temperatures between 5 °C and 25 °C, was measured using a temperature‑controlled, m-VROC®.
The m-VROC viscometer yields a wide viscosity range (from 0.2 ~ 100,000 mPa-s) and controlled temperature capabilities(4 ~ 70°C), which enables accurate viscosity measurements required to monitor and help researchers understand their high concentrated protein solutions.
Concentrated protein solutions experience a broad range of temperatures from cold storage to body temperature or even higher during an accelerated aging study. Therefore, it is very practical to measure the viscosity of protein formulations at these temperatures to predict the ability to handle or process under all relevant conditions. There is also evidence that the rate of increase in viscosity with inverse temperature, as characterized by the activation energy, reflects the dynamics of protein clusters or aggregates.