title: Characterization of protein rheology and delivery forces for combination products.
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.
authors.affiliation: Drug Product Engineering, Amgen, Thousand Oaks, California 91320, USA. nrathore@amgen.com
authors.forename: Nitin
authors.initials: N
authors.lastname: Rathore
authors.forename: Pratik
authors.initials: P
authors.lastname: Pranay
authors.forename: Joseph
authors.initials: J
authors.lastname: Bernacki
authors.forename: Bruce
authors.initials: B
authors.lastname: Eu
authors.forename: Wenchang
authors.initials: W
authors.lastname: Ji
authors.forename: Ed
authors.initials: E
authors.lastname: Walls
mesh_terms: D000906:Antibodies / Q000008:administration & dosage* / Q000737:chemistry*; D016503:Drug Delivery Systems / Q000295:instrumentation; D004867:Equipment Design; D008956:Models, Chemical; D012212:Rheology; D013594:Syringes; D013696:Temperature; D014783:Viscosity
chemical_list: D000906:Antibodies