Structure, heterogeneity and developability assessment of therapeutic antibodies
Autor: | Dongdong Wang, Jason K. Cheung, Christine Nowak, Yingda Xu, Ning Li, Wei Xu, Bruce Mason, Tony Rossomando, Dingjiang Liu, Diane D Dong, Alain Beck, Joanne Sun, Amit Katiyar, Tao Xiang, Hongcheng Liu, Smita Raghava |
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Rok vydání: | 2018 |
Předmět: |
Structure (mathematical logic)
0303 health sciences Computer science Material consumption media_common.quotation_subject Best practice Immunology Antibodies Monoclonal Review Turnaround time 03 medical and health sciences 0302 clinical medicine Workflow Risk analysis (engineering) 030220 oncology & carcinogenesis Drug Discovery Protein drug Humans Immunology and Allergy Quality (business) 030304 developmental biology media_common |
Zdroj: | mAbs. 11:239-264 |
ISSN: | 1942-0870 1942-0862 |
Popis: | Increasing attention has been paid to developability assessment with the understanding that thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid delays during late-stage development. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products and from the lessons learned from many failed development programs over the last three decades. Here, we reviewed antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes. Based on our collective experiences, a practical workflow is proposed as a best practice for developability assessment including in silico evaluation, extended characterization and forced degradation using appropriate analytical methods that allow characterization with limited material consumption and fast turnaround time. |
Databáze: | OpenAIRE |
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