Biologicals最新文献

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Corrigendum to "Preparedness and response to emerging veterinary disease outbreaks - A meeting report" [Biologicals 93 (February 2026) 101873]. “准备和应对新出现的兽医疾病爆发——会议报告”[生物制品93（2026年2月）101873]的更正。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2026-01-24 DOI: 10.1016/j.biologicals.2026.101879

Francisco Reviriego-Gordejo, Dries Minne, Ivo Claassen, Jean-Charles Cavitte, Annemarie Bouma, Olivier Debaere, Max Bastian, Dо́nal Sammin, Ely Bénéré, Ron Bergevoet, Claude Saegerman, Jacqueline Poot, Olivier Espeisse, Jean-Christophe Audonnet, Sandra Manzanares-Laya, Frédéric Descamps

引用次数: 0

Aims and Scope/Editorial Board/Publishing Details 目标和范围/编辑委员会/出版细节

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2026-01-20 DOI: 10.1016/S1045-1056(26)00003-5

引用次数: 0

Preparedness and response to emerging veterinary disease outbreaks – A meeting report 准备和应对新出现的兽疫爆发-会议报告

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2026-01-13 DOI: 10.1016/j.biologicals.2026.101873

Francisco Reviriego-Gordejo , Dries Minne , Ivo Claassen , Jean-Charles Cavitte , Annemarie Bouma , Olivier Debaere , Max Bastian , Dόnal Sammin , Ely Bénéré , Ron Bergevoet , Claude Saegerman , Jacqueline Poot , Olivier Espeisse , Jean-Christophe Audonnet , Sandra Manzanares-Laya , Frédéric Descamps

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 European Union (EU). The International Alliance for Biological Standardization hosted a meeting to address these challenges and promote discussion between different European stakeholders, with the aims of identifying current preparedness obstacles in the EU and sharing different experiences from Member States, while additionally sharing the veterinary vaccine industry perspective.

Preparedness must distinguish between expected events (usually slow-spreading diseases) and unexpected events (typically EIDs), for which the appropriate vaccination strategies remain uncertain. Key considerations include economic constraints, defining target diseases and species, and balancing the aim for ideal vaccines vs timely efficacious vaccines. Ultimately, decision-makers must address whether to react to outbreaks or proactively develop solutions in advance. Practical recommendations based on the derived discussion included the development of a collaborative framework for decision-making between different stakeholders, dedicated funds for EIDs, communication strategies with the general public, addressing logistical issues, and implementing regulatory advances to respond to emergency situations, applying pragmatic and risk-balanced approaches.

动物中新出现的传染病（eid）是农业部门破坏性暴发的原因。动物卫生准备包括及时和有效的疫苗，这在欧洲联盟（欧盟）面临监管和经济限制。国际生物标准化联盟主办了一次会议，以应对这些挑战，促进欧洲不同利益攸关方之间的讨论，目的是确定欧盟目前的防范障碍，分享成员国的不同经验，同时还分享兽医疫苗行业的观点。准备工作必须区分预期事件（通常是缓慢传播的疾病）和意外事件（通常是eid），对于这些事件，适当的疫苗接种战略仍然不确定。主要考虑因素包括经济限制、确定目标疾病和物种，以及平衡理想疫苗与及时有效疫苗的目标。最终，决策者必须考虑是应对疫情，还是提前主动制定解决方案。根据衍生性讨论提出的实际建议包括：为不同利益攸关方之间的决策制定协作框架、为eid提供专门资金、与公众沟通战略、解决后勤问题、落实监管进展以应对紧急情况、采用务实和风险平衡的方法。

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引用次数: 0

Diphtheria antitoxin potency assay: an in vitro alternative to the in vivo subcutaneous toxin neutralization test 白喉抗毒素效价测定：体内皮下毒素中和试验的体外替代方法

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-12-11 DOI: 10.1016/j.biologicals.2025.101870

Daniela Tendler Leibel Bacellar , Cristiane Santino da Silva , Antonio Alves Pereira-Júnior , Wlamir Correa de Moura , Maria Helena Simões Villas-Boas , Ana Luiza de Mattos-Guaraldi

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 neutralize circulating DT. Immediate availability of DAT is critical, especially during outbreaks. Potency testing is required before lot release, yet current pharmacopeial methods still rely on in vivo assays, such as the subcutaneous toxin neutralization test (TNT-SC) or intradermal TNT (TNT-ID). In response to efforts to reduce animal use, this study aimed to validate an in vitro potency assay for DAT using Vero cells, as an alternative to the in vivo TNT-SC for lot release. Twelve DAT samples were tested using the in vivo method and the alternative in vitro assay. Diagnostic performance (sensitivity, specificity, accuracy), agreement (Lin's CCC, Bland–Altman analysis), linearity, precision, and selectivity were evaluated. The in vitro assay showed high concordance with the in vivo method (CCC >0.90) and correctly classified all samples regarding conformity status. The assay demonstrated acceptable linearity and precision (gCV% ≤ 30 %). These results support the Vero cell assay as a relevant and reliable full replacement for in vivo TNT-SC in DAT potency determination.

白喉是一种急性传染性疾病，由于白喉毒素（DT）的作用可致人死亡。白喉抗毒素（DAT）仍然是治疗的关键，必须在症状出现后两天内给予，以有效中和循环中的白喉抗毒素。即时获得数据至关重要，特别是在疫情爆发期间。在批放行前需要进行效价检测，但目前的药典方法仍然依赖于体内检测，如皮下毒素中和试验（TNT- sc）或皮内TNT （TNT- id）。为了减少动物使用，本研究旨在验证使用Vero细胞进行DAT的体外效价测定，作为体内批量释放的TNT-SC的替代品。采用体内法和体外替代法对12个DAT样品进行检测。评估诊断性能（敏感性、特异性、准确性）、一致性（Lin’s CCC、Bland-Altman分析）、线性、精密度和选择性。体外实验显示与体内方法高度一致（CCC >0.90），并正确分类了所有符合状态的样品。该方法具有良好的线性度和精密度（gCV%≤30%）。这些结果支持Vero细胞测定法作为一种相关且可靠的完全替代体内TNT-SC测定DAT效价的方法。

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引用次数: 0

Evaluation of 1st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform 世界卫生组织首个抗疟疾竞争性ELISA标准试剂评价及ADAMSEL分析平台开发。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/j.biologicals.2025.101850

Bhagwati Khatri , Peggy Riese , Hanna Shkarlet , Daniella Mortier , Helen McShane , Paul W. Bowyer , Edmond Remarque

This study focuses on harmonising the competition ELISA (cELISA) assay for Plasmodium falciparum (P. falciparum), using the 1st WHO reference reagent for anti-malaria (P. falciparum) human reference serum (10/198). Antibody-mediated immune responses against the Apical Membrane Antigen 1 (AMA1) play a significant role in protection against malaria. However, the sequence diversity of AMA1 and cross-reactivity among variants pose challenges in assessing antibody responses. To address this, the cELISA assay was selected to examine cross-reactive antibody responses against different variants.

The harmonisation process for cELISA was performed in three laboratories. The 10/198 served as an internal standard for the calculation of IgG concentrations in the cELISA using ADAMSEL software. Additionally, a novel semi-automated analytical tool was developed in the R-statistics environment. This tool is freely available for download and streamlines generating results while minimising human error.

This study demonstrated the effectiveness of the 1st WHO reference reagent as a standard for cELISA. Additionally, the ADAMSEL software and R-platform tool provide a user-friendly and accessible tool for the analysis of cELISA data. Its automation capabilities improve efficiency and ensure global accessibility at no cost, benefitting laboratories with limited resources.

本研究的重点是统一恶性疟原虫（P. falciparum）竞争ELISA （cELISA）检测方法，使用世界卫生组织第一个抗疟疾（P. falciparum）人参考血清标准试剂（10/198）。针对顶膜抗原1 （AMA1）的抗体介导的免疫应答在疟疾保护中发挥重要作用。然而，AMA1的序列多样性和变体之间的交叉反应性给评估抗体反应带来了挑战。为了解决这个问题，我们选择了cELISA检测来检测针对不同变体的交叉反应性抗体反应。cELISA的协调过程在三个实验室进行。10/198作为内标，使用ADAMSEL软件计算cELISA中IgG浓度。此外，在R-statistics环境中开发了一种新的半自动分析工具。此工具可免费下载，并简化生成结果，同时最大限度地减少人为错误。本研究证明了世卫组织第一种参比试剂作为cELISA标准试剂的有效性。此外，ADAMSEL软件和r平台工具为分析cELISA数据提供了一个用户友好且易于访问的工具。它的自动化能力提高了效率，并确保全球免费访问，使资源有限的实验室受益。

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引用次数: 0

Octanoic acid addition: a simple, affordable modification that overcomes lipid removal limitations of traditional antivenom production processes 辛酸添加：一种简单，负担得起的修改，克服了传统抗蛇毒血清生产工艺的脂质去除限制。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/j.biologicals.2025.101863

Nicolás Berardo Blanch , Diego Ignacio Olivero , Christian Leandro Macoretta , Oscar Pérez , Matías Fingermann

Since their introduction over a century ago, antivenoms have played a central role in Public Health, especially in the world's least developed regions. They are, in most cases, the only effective treatment for envenomation accidents by poisonous animals. A big proportion of currently available antivenoms are based on F(ab’)₂ immunoglobulin fragments, produced from hyperimmune equine plasma, following slightly modified protocols developed several decades ago. These protocols show severe limitations for processing starting materials with high lipid contents. In this work, we propose minor modifications to these traditional procedures, based on the addition of octanoic acid, that significantly increase their lipid removal capacities. The method designed for use at the final stages showed reductions of 85–98 % and 64–99 % in cholesterol and phosphatidylcholines, respectively. An alternative, intended for use at the initial stages of the process, improved lipid removal capacity in three out of four independent hyperimmune equine plasmas assayed. Notably, a significant reduction in oligomeric F(ab’)₂ species was also observed in all octanoic acid-treated samples. Thus, the methodologies developed and optimised in this work present simple and affordable alternatives to overcome lipid removal limitations of traditional antivenom-producing protocols.

自一个多世纪前推出以来，抗蛇毒血清在公共卫生领域发挥了核心作用，特别是在世界上最不发达地区。在大多数情况下，它们是处理有毒动物中毒事故的唯一有效方法。目前可获得的大部分抗蛇毒血清是基于F（ab’）2免疫球蛋白片段，这些片段是根据几十年前制定的稍微修改的方案从高免疫的马血浆中产生的。这些方案在处理高脂含量的原料时显示出严重的局限性。在这项工作中，我们建议对这些传统程序进行微小的修改，基于辛酸的添加，显着提高其脂质去除能力。设计用于最后阶段的方法显示，胆固醇和磷脂酰胆碱分别降低85- 98%和64- 99%。另一种替代方案，用于该过程的初始阶段，提高了四分之三的独立高免疫马血浆的脂质去除能力。值得注意的是，在所有辛酸处理的样品中也观察到寡聚物F(ab')2物种的显著减少。因此，在这项工作中开发和优化的方法提供了简单和负担得起的替代方案，以克服传统抗蛇毒血清生产方案的脂质去除限制。

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引用次数: 0

Adjuvant Synergy: Alum and chlorogenic acid enhance Th1 responses and survival in a Salmonella typhimurium challenge model 佐剂协同作用：明矾和绿原酸在鼠伤寒沙门氏菌攻击模型中增强Th1应答和存活

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/j.biologicals.2025.101864

Mahtab Pourkamalzadeh, Seyyed Meysam Abtahi Froushani, Abdolgaffar Ownagh

Alum adjuvants do not induce Th1 responses with killed microorganisms, although Th1 responses are crucial for defending against intracellular microbes. Chlorogenic acid (CGA) can shift immune responses from Th2 toward Th1. This study assessed the benefits of combining CGA with alum on cellular and humoral immunity following immunization with a heat-killed preparation of Salmonella typhimurium (HKST). Male Balb/c mice received two doses of the HKST vaccine, with or without alum, CGA, or both, administered two weeks apart. Immune responses and protection against S. typhimurium were evaluated two weeks after the final dose.The alum and CGA combination enhanced the HKST vaccine's ability to stimulate lymphocyte proliferation, delayed-type hypersensitivity reactions, and antibody titers, and alter the ratio of IgG2a/IgG in favor of IgG2a. These findings correlated with a shift toward a Th1 immune response and improved protective immunity against S. typhimurium. Also, the group receiving the combined adjuvant had a longer survival rate following exposure to the acute dose of S. typhimurium and had a lower bacterial load in the liver when exposed to the subacute dose of S. typhimurium compared to other immunization protocols. Overall,the combined alum and CGA significantly boosted cellular and humoral immunity following HKST immunization.

明矾佐剂不诱导Th1反应与杀死的微生物，尽管Th1反应是至关重要的防御细胞内微生物。绿原酸（CGA）可以将免疫反应从Th2转移到Th1。本研究评估了CGA和明矾在热杀鼠伤寒沙门菌（HKST）免疫后对细胞和体液免疫的益处。雄性Balb/c小鼠接受两剂HKST疫苗，含或不含明矾，CGA，或两者兼而有之，间隔两周注射。在最后一次给药后两周评估免疫反应和对鼠伤寒沙门氏菌的保护作用。明矾和CGA组合增强了HKST疫苗刺激淋巴细胞增殖、延迟型超敏反应和抗体滴度的能力，并改变了IgG2a/IgG的比例，有利于IgG2a。这些发现与向Th1免疫反应的转变和对鼠伤寒沙门氏菌的保护性免疫的改善有关。此外，与其他免疫方案相比，接受联合佐剂的组在暴露于急性剂量的鼠伤寒沙门氏菌后存活率更长，并且在暴露于亚急性剂量的鼠伤寒沙门氏菌时肝脏中的细菌负荷更低。总的来说，明矾和CGA的组合显著提高了HKST免疫后的细胞和体液免疫。

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引用次数: 0

Corrigendum to “Effect of biomolecules derived from human platelet-rich plasma on the ex vivo expansion of human adipose-derived mesenchymal stem cells for clinical applications” [Biologicals 75 (2022) 37–48] “从富含血小板的血浆中提取的生物分子对临床应用的人脂肪来源的间充质干细胞体外扩增的影响”的更正[生物制品75(2022)37-48]。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/j.biologicals.2025.101861

Silvia M. Becerra-Bayona , Víctor Alfonso Solarte , Juan Dario Alviar Rueda , Claudia L. Sossa  , Martha L. Arango-Rodríguez

引用次数: 0

Corrigendum to “Vaccination and surveillance for high pathogenicity avian influenza in poultry-current situation and perspectives” [Biologicals 91 (2025) 101840] “家禽中高致病性禽流感的疫苗接种和监测-现状和前景”[生物制品91(2025)101840]的勘误表。

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/j.biologicals.2025.101858

Nancy C. Sajjadi , Celia Abolnik , Francesca Baldinelli , Ian Brown , Angus Cameron , J.J. de Wit (Sjaak) , Madhur Dhingra , Olivier Espeisse , Jean Luc Guerrin , Timm Harder , Jeremy Ho , Tze-Hoong Chua , Khaled Hussein , Nicholas Lyons , Isabella Monne , Yukitake Okamuro , Damian Tago Pacheco , Gounalan Pavade , Nicolas Poncon , Teguh Yodiantara Prajitno , Arjan Stegeman

引用次数: 0

Aims and Scope/Editorial Board/Publishing Details 目标和范围/编辑委员会/出版细节

IF 1.5 4区生物学 Q4 BIOCHEMICAL RESEARCH METHODS

Biologicals

Pub Date : 2025-11-01 DOI: 10.1016/S1045-1056(25)00057-0

引用次数: 0

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