Alternative approaches to phase III clinical trials for vaccine efficacy and licensure: the role of real-world evidence - a meeting report [0.03%]
关于疫苗效力和获批的三期临床试验替代方法及真实世界数据作用的意见汇总会议报告
Laurence de Moerlooze,Alexander Allen,Ilaria Bartalesi et al.
Laurence de Moerlooze et al.
Leveraging analytical and bioprocess platforms for biological product development and commercialization - A meeting report [0.03%]
生物制品开发和商业化的分析和生物工艺平台的技术报告
Shawn Novick,Mihai Bilanin,Mihaela Buda et al.
Shawn Novick et al.
In May 2025, the International Alliance for Biological Standardization (IABS) held a workshop on analytical and bioprocess platforms for biological product development and commercialization. This workshop explored the use of platform approa...
Status and progress in the development of rDNA-derived Tocilizumab and its biosimilars for treatment of rheumatoid arthritis [0.03%]
基于rDNA的托珠单抗及其类似物治疗类风湿性关节炎的研发进展和现状
Prabir Kumar Das,Deepak Kumar Mahato,Venkata Dasu Veeranki
Prabir Kumar Das
The immune system unintentionally targets the synovial lining of the joints in rheumatoid arthritis (RA), a chronic autoimmune disease that causes inflammation, discomfort, and gradual joint destruction. A humanized anti-IL-6R monoclonal an...
Antioxidant excipient-mediated stabilization preserves FcγRIIIa binding and ADCC activity of rituximab [0.03%]
抗氧化辅剂介导的稳定保护利妥昔单抗对FcγRIIIa的结合和ADCC活性
Aditya Narvekar,Utkarsh Tathe,Amita Puranik et al.
Aditya Narvekar et al.
Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the mechanisms of action of therapeutic monoclonal antibodies (mAbs). This mechanism of action is often enhanced either through Fc mutagenesis or glycoengineering. However, cert...
Optimization of a U937 cell-based reporter system to assess ADCC activity of ustekinumab versus trastuzumab [0.03%]
优化U937细胞报告系统以评估乌司奴单抗与曲妥珠单抗的抗体依赖性细胞毒性活性
Gandharv Singh Rawat,Rakesh Kumar Sinha,Jayachandran Ramalingam et al.
Gandharv Singh Rawat et al.
In the present study, the human monocytic U937 cell line, which intrinsically expresses low levels of membrane-bound IL-12, was systematically optimized to establish a robust target cell system for a surrogate ADCC reporter assay aimed at e...
Preparation of poloxamer-based CPV virus-like particle vaccine and its immunological evaluation in mice [0.03%]
基于泊洛沙姆的细小病毒VP2病毒样颗粒疫苗的制备及免疫效果评价
Fei Mo,Jing Qian,Yeping Tan et al.
Fei Mo et al.
Poloxamers are thermosensitive triblock copolymers valued for their safety and sustained-release properties. Using China's prevalent CPV-2c strain (JSLYG-18) of canine parvovirus (CPV), we produced virus-like particles (VLPs) via prokaryoti...
Oral immunization with engineered probiotics expressing tcdB protects mice against Clostridioides difficile infection [0.03%]
表达tcdB的工程益生菌口服免疫保护小鼠免受难辨梭状芽孢杆菌感染
May M A Bahr,Marwa T ElRakaiby,Abd El-Nasser A Madboli et al.
May M A Bahr et al.
Clostridioides difficile infection (CDI) is a major global health concern driven by the virulence factors toxins A (TcdA) and B (TcdB). Vaccination targeting these toxins, particularly via the oral mucosal route, represents a promising prev...
Corrigendum to "Preparedness and response to emerging veterinary disease outbreaks - A meeting report" [Biologicals 93 (February 2026) 101873] [0.03%]
对“新兴兽医疾病的准备和应对——会议报告”[生物制品 X卷（2026年2月）XX篇] 的勘误通知
Francisco Reviriego-Gordejo,Dries Minne,Ivo Claassen et al.
Francisco Reviriego-Gordejo et al.
Preparedness and response to emerging veterinary disease outbreaks - A meeting report [0.03%]
新型动物疾病暴发的应对与处置国际研讨会报告
Francisco Reviriego-Gordejo,Dries Minne,Ivo Claassen et al.
Francisco Reviriego-Gordejo et al.
Emerging infectious diseases (EIDs) in animals are responsible for disruptive outbreaks in the agricultural sector. Animal health preparedness includes timely and effective vaccines, which face regulatory and economic constraints in the Eur...
Diphtheria antitoxin potency assay: an in vitro alternative to the in vivo subcutaneous toxin neutralization test [0.03%]
白喉抗毒素效力测定：体外替代活体内皮下毒性中和试验的方法
Daniela Tendler Leibel Bacellar,Cristiane Santino da Silva,Antonio Alves Pereira-Júnior et al.
Daniela Tendler Leibel Bacellar et al.
Diphtheria is an acute infectious disease that can be fatal due to the action of diphtheria toxin (DT). Diphtheria antitoxin (DAT) remains essential for treatment and must be administered within two days of symptom onset to effectively neut...