Paper Number
BM15 

Session
Biological Macromolecules: Proteins, Cellulosic Biomass and other Biomaterials

Title
A “syringe-on-chip” device for quantitative injectability study of concentrated protein solutions

Presentation Date and Time
October 12, 2015 (Monday) 5:40

Track / Room
Track 4 / Constellation F

Authors (Click on name to view author profile)

1. Lanzaro, Alfredo (the University of Manchester, School of Chemical Engineering and Analytical Science)
2. Curtis, Robin (the University of Manchester, School of Chemical Engineering and Analytical Science)
3. Pathak, Jai (Medimmune, Formulation Sciences Department)
4. Yuan, Xue-Feng (Interdisciplinary Institute of High-Performance Computing, The National Supercomputer Centre)

Author and Affiliation Lines (in printed abstract book)
Alfredo Lanzaro¹, Robin Curtis¹, Jai Pathak², and Xue-Feng Yuan^3
1School of Chemical Engineering and Analytical Science, the University of Manchester, Manchester, Greater Manchester M1 7DN, United Kingdom; ²Formulation Sciences Department, Medimmune, Gaithersburg, MD 20878; ³The National Supercomputer Centre, Interdisciplinary Institute of High-Performance Computing, Guangzhou, China

Speaker / Presenter 
Lanzaro, Alfredo

Text of Abstract
We present a systematic study of the flow of well-characterised protein solutions in microfluidic syringe-like flow geometries, motivated by the objective of developing scaled-down models for measuring syringe performance – “syringeability.” We focus on well-characterised monoclonal antibody formulations, as well as bovine and human albumin solutions prepared over a range of concentrations (1 g/L <c <400 g/L) and with different formulation conditions such as buffer pH. The rheometric properties of protein solutions are characterised in the range of deformation rates typical of syringeability tests using the Rheo-chip platform developed at Univ. of Manchester (1). The available data include transient and steady shear viscosity measured over a range of shear rates as high as 10^5 s^(-1) , and also extensional viscosity measured using our microfluidic “cross slot” device up to 10^4 s^(-1). It is important to measure both shear and extensional viscosity to describe syringe flow, as both flow kinematics exist in a syringe/needle and contribute to the total pressure drop. The complex flow of protein solutions is studied by means of a novel microfluidic “syringe-on-chip” device, which mimics the shear rate conditions encountered by concentrated protein solutions during injection using different needle gauge sizes. Measurements of pressure drop, velocity field and birefringence are performed (2,3). The results obtained in microfluidic flow conditions are critically compared with the outcomes of conventional syringeability tests performed with texture analysis systems. This systematic approach will lead to an effective scale down of syringe injection tests, with consequent minimisation of required sample, and will allow for optimisation of the design of drug delivery devices.

REFERENCES: [1] Yuan, X.-F., US Patent App. 13/813,933, 2011. [2] A. Lanzaro and X.-F. Yuan, JNNFM, 166 (1064-1075), 2011. [3] A. Lanzaro and X.-F. Yuan, JNNFM, 207 (32-41), 2014.