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Related Experiment Video

Updated: Dec 12, 2025

Integrated Cell Manipulation Platform Coupled with the Single-probe for Mass Spectrometry Analysis of Drugs and Metabolites in Single Suspension Cells

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Simultaneous Monitoring and Comparison of Multiple Product Quality Attributes for Cell Culture Processes at Different

Yang Liu¹, Janice Fernandez², Zheng Pu³

¹CMC Analytical, Product Development & Supply, GlaxoSmithKline, Pennsylvania 19406, USA.

Journal of Pharmaceutical Sciences

|August 8, 2020

Summary

This study demonstrates a multi-attribute method (MAM) for monitoring critical quality attributes (CQAs) in monoclonal antibody production. This analytical approach supports bioprocess control and quality assurance during manufacturing scale-up.

Keywords:

CQAs trending Cell culture process LC-MS MAM QbD

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An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry

An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry

Published on: April 17, 2018

Area of Science:

Biopharmaceutical Manufacturing
Analytical Chemistry
Process Analytical Technology (PAT)

Background:

The biopharmaceutical industry is adopting Quality by Design (QbD) principles, emphasizing process understanding and control.
Ensuring drug product safety and efficacy necessitates defining critical quality attributes (CQAs) and their relationship with critical process parameters (CPPs).

Purpose of the Study:

To apply a liquid chromatography-mass spectrometry (LC-MS) based multi-attribute method (MAM) for monitoring and trending multiple CQAs of a monoclonal antibody (mAb).
To demonstrate the first-time application of MAM in both a small-scale development bioreactor and a large-scale GMP single-use bioreactor (SUB).

Main Methods:

Implementation of a multi-attribute method (MAM) utilizing liquid chromatography-mass spectrometry (LC-MS).
Application of MAM for monitoring multiple critical quality attributes (CQAs) in a monoclonal antibody (mAb) product.
Utilizing MAM across different scales: a 3-liter development bioreactor and a 2000-liter GMP single-use bioreactor (SUB).

Main Results:

MAM successfully monitored and trended multiple CQAs throughout a 17-day cell culture process.
The method provided critical product quality information, enabling the assessment of process performance differences during scale-up and technology transfer.
This represents the initial application of MAM in both development and GMP manufacturing bioreactor scales.

Conclusions:

MAM is a robust analytical tool for monitoring bioprocess product quality attributes over time.
The findings establish a foundation for future real-time in-process control and release strategies for biotherapeutics using MAM.
This approach aids in understanding process variability and ensuring consistent product quality during manufacturing scale-up.