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https://hdl.handle.net/2440/54812
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Type: | Journal article |
Title: | Determining antibody stability: Creation of solid-liquid interfacial effects within a high shear environment |
Author: | Biddlecombe, J. Craig, A. Zhang, H. Uddin, S. Mulot, S. Fish, B. Bracewell, D. |
Citation: | Biotechnology Progress, 2007; 23(5):1218-1222 |
Publisher: | Amer Chemical Soc |
Issue Date: | 2007 |
ISSN: | 8756-7938 1520-6033 |
Statement of Responsibility: | James G. Biddlecombe, Alan V. Craig, Hu Zhang, Shahid Uddin, Sandrine Mulot, Brendan C. Fish and Daniel G. Bracewell |
Abstract: | The purpose of this study was to assess the stability of protein formulations using a device designed to generate defined, quantifiable levels of shear in the presence of a solid-liquid interface. The device, based on a rotating disk, produced shear strain rates of up to 3.4 × 104 s-1 (at 250 rps) and was designed to exclude air-liquid interfaces and enable temperature to be controlled. Computational fluid dynamics (CFD) was used to study the fluid flow patterns within the device and to determine the shear strain rate (s-1) at a range of disk speeds. The device was then used to study the effect on a monoclonal IgG4 of high levels of shear at the solid-liquid interface. Monomeric antibody concentration and aggregation of the protein in solution were monitored by gel permeation HPLC and turbidity at 350 nm. High shear strain rates were found to cause significant levels of protein aggregation and precipitation with reduction of protein monomer following first-order kinetics. Monomer reduction rate was determined for a range of disk speeds and found to have a nonlinear relationship with shear strain rate, indicating the importance of identifying and minimizing such environments during processing. |
Keywords: | Antibodies Chromatography, High Pressure Liquid Nephelometry and Turbidimetry Equipment Design Equipment Failure Analysis Physical Stimulation Microfluidics Drug Stability Shear Strength |
DOI: | 10.1021/bp0701261 |
Published version: | http://dx.doi.org/10.1021/bp0701261 |
Appears in Collections: | Aurora harvest Chemical Engineering publications |
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