Skip to main content

NOTICE: Due to a lapse in annual appropriations, most of this website is not being updated. Learn more.

Form submissions will still be accepted but will not receive responses at this time. Sections of this site for programs using non-appropriated funds (such as NVLAP) or those that are excepted from the shutdown (such as CHIPS and NVD) will continue to be updated.

U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

The impact of the metal interface on the stability and quality of a therapeutic fusion protein

Published

Author(s)

Adrian P. Defante, Steven D. Hudson, Cavan K. Kalonia, Emma Keegan, Steven Bishop, Paul Santacroce, Satish Hasige

Abstract

Subvisible particle formation which occurs after the sterile filtration step of the fill/finish process is challenge that may occur during the development of biotherapeutics with complex molecular structures. Here, we show that a stainless-steel pump head from a rotary piston pump produces more protein aggregates, past the limit of the acceptable quality range for sub- visible particle counts, in comparison to a ceramic pump head. Quartz-crystal microbalance was used to quantify the primary layer, a protein irreversibly adsorbed at the solid-liquid interface, and the secondary diffuse gel like layer interacting on top of the primary layer. The results showed the mass of irreversibly protein adsorbed onto stainless steel sensors is greater than on an aluminum oxide surface (ceramic pump mimic). This suggests that the amount of adsorbed protein plays a role on surface-induced protein aggregation at the solid-liquid interface.
Citation
Molecular Pharmaceutics
Volume
17
Issue
2

Keywords

fusion protein, protein adsorption, sub-visible particles, solid-liquid interface, protein aggregation

Citation

Defante, A. , Hudson, S. , Kalonia, C. , Keegan, E. , Bishop, S. , Santacroce, P. and Hasige, S. (2020), The impact of the metal interface on the stability and quality of a therapeutic fusion protein, Molecular Pharmaceutics, [online], https://doi.org/10.1021/acs.molpharmaceut.9b01000 (Accessed October 12, 2025)

Issues

If you have any questions about this publication or are having problems accessing it, please contact [email protected].

Created January 9, 2020, Updated May 4, 2021
Was this page helpful?