Description: Injectability of high concentration (> 100 mg/mL) drug formulations (i.e. mAbs) is determined by measuring the injection force and ensuring it is below a specified threshold. The injection force can be well-calculated by taking viscosity measurements for a wide range of shear rates (one dispensing flow rate corresponds to a shear rate gradient across the needle).
Challenges for accurate calculation of injection force are:
· Viscosity measurements for low shear rates are not enough for high concentration formulations that exhibit shear thinning up to 150,000 1/s. · At early stages, only low volumes of drug product may be available ( < 100 µL). · Measuring sample-after-sample can be labor-intensive and time-consuming.
To address these challenges, we use RheoSense VROC microfluidic technology for fully automated viscosity testing of small volumes ( < 100 µL) of concentrated mAb samples across a wide shear rate range (up to 150,000 1/s) with high accuracy (±2%) and repeatability (±0.5%).
We demonstrate how to use these wide shear rate sweeps to:
· Determine the sample’s injection force for multiple syringe geometries and multiple dispensing flow rates. · Calculate mAb or protein cluster size for concentrated samples applicable to injectable formulations.
Learning Objectives:
Participant understands why viscosity measurements for low shear rates are not enough for high concentration formulations that exhibit shear thinning up to 150,000 1/s.
Participant understands how VROC microfluidic technology allows for fully automated viscosity testing of small volumes (< 100 µL) of drug formulations
Participant understands how VROC microfluidic technology allows for fully automated viscosity testing across a wide shear rate range (up to 150,000 1/s) with high accuracy (±2%) and repeatability (±0.5%).
