Multi-attribute Raman spectroscopy (MARS) for monitoring product quality attributes in formulated monoclonal antibody therapeutics
| Autor: | Bingchuan Wei, Nicholas Woon, Lu Dai, Raphael Fish, Michelle Tai, Winode Handagama, Ashley Yin, Jia Sun, Andrew Maier, Dana McDaniel, Elvira Kadaub, Jessica Yang, Miguel Saggu, Ann Woys, Oxana Pester, Danny Lambert, Alex Pell, Zhiqi Hao, Gordon Magill, Jack Yim, Jefferson Chan, Lindsay Yang, Frank Macchi, Christian Bell, Galahad Deperalta, Yan Chen |
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| Rok vydání: | 2021 |
| Předmět: |
Quality Control
protein characterization multivariate data analysis Immunology Antibodies Monoclonal formulation RM1-950 CHO Cells RC581-607 Spectrum Analysis Raman Multi-attribute methods Recombinant Proteins product quality attributes real-time release testing design of experiments Cricetulus monoclonal antibody Report Raman spectroscopy Animals Immunology and Allergy Therapeutics. Pharmacology Immunologic diseases. Allergy |
| Zdroj: | mAbs article-version (VoR) Version of Record mAbs, Vol 14, Iss 1 (2022) |
| ISSN: | 1942-0870 1942-0862 |
| Popis: | Rapid release of biopharmaceutical products enables a more efficient drug manufacturing process. Multi-attribute methods that target several product quality attributes (PQAs) at one time are an essential pillar of the rapid-release strategy. The novel, high-throughput, and nondestructive multi-attribute Raman spectroscopy (MARS) method combines Raman spectroscopy, design of experiments, and multivariate data analysis (MVDA). MARS allows the measurement of multiple PQAs for formulated protein therapeutics without sample preparation from a single spectroscopic scan. Variable importance in projection analysis is used to associate the chemical and spectral basis of targeted PQAs, which assists in model interpretation and selection. This study shows the feasibility of MARS for the measurement of both protein purity-related and formulation-related PQAs; measurements of protein concentration, osmolality, and some formulation additives were achieved by a generic multiproduct model for various protein products containing the same formulation components. MARS demonstrates the potential to be a powerful methodology to improve the efficiency of biopharmaceutical development and manufacturing, as it features fast turnaround time, good robustness, less human intervention, and potential for automation. |
| Databáze: | OpenAIRE |
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