Jaeger, Seiji (2025) High Performance Countercurrent Membrane Purification for HCP depletion in biologics. High Performance Countercurrent Membrane Purification for HCP depletion in biologics.

Abstract

Submission of Bachelor-Thesis (CDA between Novartis and University FHNW Muttenz in place)

As research and development of biologics manufacturing advances, high performance membrane
purification (HPCMP) for host cell protein (HCP) depletion in biologics becomes an attractive
alternative to conventional protein A and therapeutic protein capture methods, as it provides
a non-specific, cost effective and easily scalable process for capture. In this study, Repligen
Cytiva and Solventum membranes with various molecular weight cut-off as well as the addition
of L-arginine as an excipient were tested with model proteins such as immunoglobulin G,
myoglobin (Mb), lysozyme (Lyz), and albumin to test their reduction performance. Repligen
membranes show a lower mass transfer coefficient kc,Repligen = 3.710-07 m
s compared to
kc,Solventum = 1 * 10-06 m
s Solventum membranes for Mb / Lyz, which makes Repligen and Cytiva
membranes not suitable for HPCMP, although they show potential if further investigated.
HPCMP performed with 50 kDa therapeutic protein intermediate (TP50) and 100 kDa therapeutic
protein intermediate (TP100) resolved with a reduction factor rTP50 = 17 and rTP100 = 2.25
while maintaining a yield YTP50 = 69.61 % and YTP100 = 84.17 %, although HPCMP with TP50
proves to have a higher yield loss and inconsistent results, overall it reached a higher HCP depletion
than HPCMP with TP100 due to the greater difference in HCP concentration.

Item Type:	Article
Date Deposited:	28 Mar 2025 00:45
Last Modified:	28 Mar 2025 00:45
URI:	https://oak.novartis.com/id/eprint/56637