Assessment of Functional Characterization and Comparability of Biotherapeutics: a Review

被引:8
|
作者
Dash, Rozaleen [1 ]
Singh, Sumit Kumar [1 ,2 ]
Chirmule, Narendra [3 ]
Rathore, Anurag S. [1 ]
机构
[1] Indian Inst Technol Delhi, Dept Chem Engn, DBT Ctr Excellence Biopharmaceut Technol, Hauz Khas, New Delhi 110016, India
[2] IIT BHU, Sch Biochem Engn, Varanasi, Uttar Pradesh, India
[3] SymphonyTech Biol, Pune, Maharashtra, India
来源
AAPS JOURNAL | 2021年 / 24卷 / 01期
关键词
cell-based assay; critical quality attributes (CQAs); functional comparability; ligand binding assay; mechanism of action (MOA); PROPOSED BIOSIMILAR RITUXIMAB; THERAPEUTIC ANTIBODIES; MONOCLONAL-ANTIBODIES; BIOLOGICAL-ACTIVITY; QUALITY ATTRIBUTES; EFFECTOR FUNCTIONS; RELATIVE POTENCY; CHARGE VARIANTS; BINDING; IMPACT;
D O I
10.1208/s12248-021-00671-0
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The development of monoclonal antibody (mAb) biosimilars is a complex process. The key to their successful development and commercialization is an in-depth understanding of the key product attributes that impact safety and efficacy and the strategies to control them. Functional assessment of mAb is a crucial part of the comparability of biopharmaceutical drugs. The development of a relevant and robust functional assay requires an interdisciplinary approach and sufficient flexibility to balance regulatory concerns as well as dynamics and variability during the manufacturing process. Although many advanced tools are available to study and compare the potency and bioactivity of the protein, most of these techniques suffer from major shortcomings that limit their routine use. These include the complexity of the task, establishment of the relevance of the chosen method with the mechanism of action (MOA) of the biosimilar, cost and extended time of analysis, and often the ambiguity in interpretation of the resulting data. To overcome or to address these challenges, the use of multiple orthogonal state-of-the-art techniques is a necessary prerequisite.
引用
收藏
页数:11
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