In-line monitoring of surfactant clearance in viral vaccine downstream processing.

ABSTRACT:

Purpose

The goal of this study is to examine the suitability of in-line infrared measurements to monitor, in real-time, surfactant concentration in the viral vaccine drug substance during a 50KDa tangential flow filtration (TFF) process.

Methods

A ReactIR™ 702L instrument was used to gather spectra of process off-line samples and reference materials to assess the feasibility of monitoring surfactant concentration during a TFF process in real-time. Both univariate and multivariate models were used to evaluate the off-line sample data and were found to be in good agreement with surfactant concentration values obtained by HPLC. These results were used as justification for a real-time TFF experiment with live process material.

Results

Small scale ReactIR experiments with

SUBMITTER: Payne J 

PROVIDER: S-EPMC8056174 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature