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Updated: May 11, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method
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为建立戈利穆马布生物参考制剂第1批的合作研究

M Wadhwa1, P Rigsby2, M-E Behr-Gross3

  • 1Medicines and Healthcare products Regulatory Agency, Biotherapeutics and Advanced Therapies, R&D Division, Blanche Lane, South Mimms, Potters Bar, UK.

Pharmeuropa bio & scientific notes
|December 3, 2024
PubMed
概括

一个新的golimumab标准 (22/116) 被确立为第一个世界卫生组织国际标准和欧洲药典生物参考准备剂的强度测试. 这一标准对瘤亡因子中和活性赋予了500 IU/的强度.

关键词:
生物参考制剂 生物参考制剂生物标准化计划 生物标准化计划在EDQM中使用EDQM.欧洲药典 欧洲药典戈利慕姆巴布 (Golimumab) 是一个非常古老的生物.抗瘤坏死因子 抗瘤坏死因子这是一种单克隆抗体.

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