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Updated: May 19, 2026

Force-Clamp Rheometry for Characterizing Protein-based Hydrogels
Published on: August 21, 2018
Characterization of protein rheology and delivery forces for combination products
Nitin Rathore1, Pratik Pranay, Joseph Bernacki
1Drug Product Engineering, Amgen, Thousand Oaks, California 91320, USA. nrathore@amgen.com
Abstract:
Characterization of a protein-device combination product over a wide range of operating parameters defined by end-user requirements is critical for developing a product presentation that is convenient for patient use. In addition to the device components, several product attributes, such as product rheology and product-container interactions, govern the functionality of a delivery system. This article presents results from a characterization study conducted for a high-concentration antibody product in a prefilled syringe. Analytical models are used to study the rheological behavior and to estimate delivery forces over a broad design space comprising temperature, concentration, and shear stress. Data suggest that high-viscosity products may exhibit significant shear thinning under the shear rates encountered under desired injection times.
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