Omnic 8.33/19/2021
Especially monoclonal antibodies are very delicate products to fill and the use of the right fill finish equipment plays an important role during process development.Protein aggregation can occur under conditions described in literature and can be influenced by the fill finish processing.The mechanism of product stress inside the filling systems is yet not fully understood.
This study evaluated three different dosing systems to assess protein degradation caused by the shear rate during low volume filling of monoclonal antibodies. The newly developed quantitative liposomal shear stress model revealed the highest shear rate in the radial peristaltic pump, followed by the rotary piston pump and the linear peristaltic pump. In contrast to that, we found the highest sub-visible particle counts (2 m) in the rotary piston pump. We used computational fluid dynamics for a better and deeper understanding of filling processes inside the different dosing systems. Our results document that the rotary piston pump creates a recirculation zone inside the cylinder, where the protein formulation could be trapped and be exposed to the shear stress multiple times resulting in a cumulative shearing. This finding could serve as an explanation for the highest sub-particle counts in low volume filling using a rotary piston pump. Graphical abstract Download: Download high-res image (38KB) Download: Download full-size image Previous article in issue Next article in issue Keywords Low volume filling Shear stress Microdosing Proteins Particle size Computational Fluid Dynamics (CFD) Particle formation Recommended articles Citing articles (0) View Abstract 2019 The Authors. Published by Elsevier B.V. Recommended articles No articles found. Citing articles Article Metrics View article metrics About ScienceDirect Remote access Shopping cart Advertise Contact and support Terms and conditions Privacy policy We use cookies to help provide and enhance our service and tailor content and ads. ![]() ![]()
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