商业化
风险分析(工程)
可比性
关键质量属性
质量(理念)
过程(计算)
单克隆抗体
计算机科学
新产品开发
计算生物学
业务
生物
免疫学
抗体
哲学
数学
认识论
组合数学
营销
操作系统
作者
Alain Beck,Christian Nowak,Deborah Meshulam,Kristina Reynolds,David Chen,Dennis B Pacardo,Samantha B. Nicholls,Gregory J. Carven,Zhenyu Gu,Jing Fang,Dongdong Wang,Amit Katiyar,Xiang Tang,Hongcheng Liu
出处
期刊:Antibodies
[MDPI AG]
日期:2022-11-20
卷期号:11 (4): 73-73
被引量:9
标识
DOI:10.3390/antib11040073
摘要
Since the first approval of the anti-CD3 recombinant monoclonal antibody (mAb), muromonab-CD3, a mouse antibody for the prevention of transplant rejection, by the US Food and Drug Administration (FDA) in 1986, mAb therapeutics have become increasingly important to medical care. A wealth of information about mAbs regarding their structure, stability, post-translation modifications, and the relationship between modification and function has been reported. Yet, substantial resources are still required throughout development and commercialization to have appropriate control strategies to maintain consistent product quality, safety, and efficacy. A typical feature of mAbs is charge heterogeneity, which stems from a variety of modifications, including modifications that are common to many mAbs or unique to a specific molecule or process. Charge heterogeneity is highly sensitive to process changes and thus a good indicator of a robust process. It is a high-risk quality attribute that could potentially fail the specification and comparability required for batch disposition. Failure to meet product specifications or comparability can substantially affect clinical development timelines. To mitigate these risks, the general rule is to maintain a comparable charge profile when process changes are inevitably introduced during development and even after commercialization. Otherwise, new peaks or varied levels of acidic and basic species must be justified based on scientific knowledge and clinical experience for a specific molecule. Here, we summarize the current understanding of mAb charge variants and outline risk-based control strategies to support process development and ultimately commercialization.
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