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Prospects and current use of the multi-attribute method for quality control of therapeutic antibodies
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Hong WANG1, Jin XU2, Hong-rui YIN1, Ming-ming XU1, Jin LING1, Huai-zu GUO2, Hong SHAO1, Gang CHEN1, *
Acta Pharmaceutica Sinica | 2020, 55(9) : 2092 - 2098
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Acta Pharmaceutica Sinica | 2020, 55(9): 2092-2098
• Reviews •
Prospects and current use of the multi-attribute method for quality control of therapeutic antibodies
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Hong WANG1, Jin XU2, Hong-rui YIN1, Ming-ming XU1, Jin LING1, Huai-zu GUO2, Hong SHAO1, Gang CHEN1, *
Affiliations
  • 1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
  • 2. State Key Laboratory of Antibody Medicine and Targeted Therapy, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
Published: 2020-09-12 doi: 10.16438/j.0513-4870.2020-0200
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In recent years therapeutic proteins products including therapeutic antibodies have become a major driving force for the modern biopharmaceutical industry. However, they have complex product quality attributes (PQAs) which limit product development and quality control (QC). Recent advances in high resolution mass spectrometry (MS) have led to the use of an MS-based multi-attribute method (MAM) for quality control testing of therapeutic proteins, which allows for direct measurement of multiple PQAs and identification of impurities. MAM helps to promote the improvement of product quality and QC and a reduction in manufacturing cost. To explore the application of MAM in QC, we discuss generic MAM workflow, the current state of MAM application in product development and QC, identify points to consider for use of MAM as a QC test, and summarize MAM's advantages and challenges in this article. The future application of MAM for therapeutic antibodies and the opportunities for its further development, use, and substitution for conventional methods is presented.

mass spectrometry  /  multi-attribute method  /  therapeutic antibody  /  quality control  /  prospect
Hong WANG, Jin XU, Hong-rui YIN, Ming-ming XU, Jin LING, Huai-zu GUO, Hong SHAO, Gang CHEN. Prospects and current use of the multi-attribute method for quality control of therapeutic antibodies[J]. Acta Pharmaceutica Sinica, 2020 , 55 (9) : 2092 -2098 . DOI: 10.16438/j.0513-4870.2020-0200
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Article Info
doi: 10.16438/j.0513-4870.2020-0200
  • Receive Date：2020-02-28
  • Online Date：2026-01-23
  • Published：2020-09-12
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  • Received：2020-02-28
  • Revised：2020-04-01
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Affiliations
    1. Shanghai Institute for Food and Drug Control, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
    2. State Key Laboratory of Antibody Medicine and Targeted Therapy, NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai 201203, China
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