Biologicals最新文献

{"title":"Preparedness and response to emerging veterinary disease outbreaks – A meeting report","authors":"Francisco Reviriego-Gordejo ,&nbsp;Dries Minne ,&nbsp;Ivo Claassen ,&nbsp;Jean-Charles Cavitte ,&nbsp;Annemarie Bouma ,&nbsp;Olivier Debaere ,&nbsp;Max Bastian ,&nbsp;Dόnal Sammin ,&nbsp;Ely Bénéré ,&nbsp;Ron Bergevoet ,&nbsp;Claude Saegerman ,&nbsp;Jacqueline Poot ,&nbsp;Olivier Espeisse ,&nbsp;Jean-Christophe Audonnet ,&nbsp;Sandra Manzanares-Laya ,&nbsp;Frédéric Descamps","doi":"10.1016/j.biologicals.2026.101873","DOIUrl":"10.1016/j.biologicals.2026.101873","url":null,"abstract":"<div><div>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.</div><div>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.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"93 ","pages":"Article 101873"},"PeriodicalIF":1.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145977548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diphtheria antitoxin potency assay: an in vitro alternative to the in vivo subcutaneous toxin neutralization test","authors":"Daniela Tendler Leibel Bacellar ,&nbsp;Cristiane Santino da Silva ,&nbsp;Antonio Alves Pereira-Júnior ,&nbsp;Wlamir Correa de Moura ,&nbsp;Maria Helena Simões Villas-Boas ,&nbsp;Ana Luiza de Mattos-Guaraldi","doi":"10.1016/j.biologicals.2025.101870","DOIUrl":"10.1016/j.biologicals.2025.101870","url":null,"abstract":"<div><div>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 <em>in vivo</em> 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 <em>in vitro</em> potency assay for DAT using Vero cells, as an alternative to the <em>in vivo</em> TNT-SC for lot release. Twelve DAT samples were tested using the <em>in vivo</em> method and the alternative <em>in vitro</em> assay. Diagnostic performance (sensitivity, specificity, accuracy), agreement (Lin's CCC, Bland–Altman analysis), linearity, precision, and selectivity were evaluated. The <em>in vitro</em> assay showed high concordance with the <em>in vivo</em> method (CCC &gt;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 <em>in vivo</em> TNT-SC in DAT potency determination.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"93 ","pages":"Article 101870"},"PeriodicalIF":1.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145712287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aims and Scope/Editorial Board/Publishing Details","authors":"","doi":"10.1016/S1045-1056(26)00003-5","DOIUrl":"10.1016/S1045-1056(26)00003-5","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"93 ","pages":"Article 101875"},"PeriodicalIF":1.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146038134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"Preparedness and response to emerging veterinary disease outbreaks - A meeting report\" [Biologicals 93 (February 2026) 101873].","authors":"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","doi":"10.1016/j.biologicals.2026.101879","DOIUrl":"https://doi.org/10.1016/j.biologicals.2026.101879","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":" ","pages":"101879"},"PeriodicalIF":1.5,"publicationDate":"2026-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of 1st WHO anti-malaria reference reagent for competition ELISA harmonisation and development of ADAMSEL analytical platform","authors":"Bhagwati Khatri ,&nbsp;Peggy Riese ,&nbsp;Hanna Shkarlet ,&nbsp;Daniella Mortier ,&nbsp;Helen McShane ,&nbsp;Paul W. Bowyer ,&nbsp;Edmond Remarque","doi":"10.1016/j.biologicals.2025.101850","DOIUrl":"10.1016/j.biologicals.2025.101850","url":null,"abstract":"<div><div>This study focuses on harmonising the competition ELISA (cELISA) assay for <em>Plasmodium falciparum</em> (<em>P. falciparum</em>), using the 1st WHO reference reagent for anti-malaria (<em>P. falciparum</em>) 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.</div><div>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.</div><div>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.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101850"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Report of the fourth conference on next-generation sequencing (NGS) for adventitious virus detection in biologics for humans and animals: Validation and implementation of NGS","authors":"Arifa S. Khan ,&nbsp;Laurent Mallet ,&nbsp;Johannes Blümel ,&nbsp;Noémie Deneyer ,&nbsp;Sigrid De C.J. Keersmaecker ,&nbsp;Blandine de Saint-Vis ,&nbsp;Ivana Knezevic ,&nbsp;Carine Logvinoff ,&nbsp;Marie Murphy ,&nbsp;Siemon H.S. Ng ,&nbsp;Yoji Sato ,&nbsp;Michael Wall ,&nbsp;Ana Goios ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2025.101859","DOIUrl":"10.1016/j.biologicals.2025.101859","url":null,"abstract":"<div><div>This report is a summary of the 4th Conference on NGS for Adventitious Virus Detection, which took place on December 4–5, 2024, in Frankfurt, Germany, and was sponsored by the International Alliance for Biological Standardization (IABS), and co-chaired by the U.S. Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines &amp; HealthCare (EDQM). The increased interest in using NGS for adventitious virus detection follows its recent introduction in the ICH Q5A (R2) guideline and the new EDQM/European Pharmacopoeia general chapter 2.6.41. Key conference objectives included evaluating NGS validation and implementation, addressing regional challenges, and discussing regulatory acceptance as an alternative method to the conventional assays. The conference fostered networking between early and established NGS users and emphasized the Advanced Virus Detection Technologies Working Group as a key learning hub for NGS applications. Discussions focused on method validation requirements and the need for defining a specific limit of detection. Participants shared updates on scientific developments and regulatory submissions. A general consensus was reached on the readiness of NGS to replace the <em>in vivo</em> adventitious virus detection assays and PCR assays, and to supplement or replace the <em>in vitro</em> cell-based assays, based on a suitable validation package.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101859"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145049269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A new Japanese regulatory perspective regarding the indication extrapolation between approved intravenous immunoglobulins (IVIg) products based on comparability assessments of quality attributes","authors":"Takashi Kameda ,&nbsp;Kazuki Nagashima ,&nbsp;Shun Masuta ,&nbsp;Teruhide Yamaguchi ,&nbsp;Michihiro Ogawa","doi":"10.1016/j.biologicals.2025.101860","DOIUrl":"10.1016/j.biologicals.2025.101860","url":null,"abstract":"<div><div>Intravenous immunoglobulin (IVIg) product is a pooled human plasma-derived IgG medicinal product indicated for various immunodeficiency and autoimmune diseases. These indications have essentially been approved in Japan based on clinical evaluations of each product, but a harmonization or standardization of IVIg products would be helpful. We introduce a new Japanese regulatory perspective on the extrapolation of indications for approved IVIg products from a reference product composed of intact IgG (chemically unmodified full-length IgG) based on the consideration of the mode of action (MOA), a quality-comparability analysis, and the post-marketing clinical track record's re-examination regarding the products' efficacy and safety.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101860"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145049270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Octanoic acid addition: a simple, affordable modification that overcomes lipid removal limitations of traditional antivenom production processes","authors":"Nicolás Berardo Blanch ,&nbsp;Diego Ignacio Olivero ,&nbsp;Christian Leandro Macoretta ,&nbsp;Oscar Pérez ,&nbsp;Matías Fingermann","doi":"10.1016/j.biologicals.2025.101863","DOIUrl":"10.1016/j.biologicals.2025.101863","url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101863"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145410840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The pharmacokinetics and safety comparison of Zamerovimab and Mazorelvimab monoclonal antibodies vs. HRIG in category III rabies post-exposure prophylaxis: a stratified analysis by wound characteristics","authors":"Xiaoqiang Liu ,&nbsp;Yongxian Zha ,&nbsp;Zhengxiong Wang ,&nbsp;Ya Jiang ,&nbsp;Xiangyu Zhang ,&nbsp;Jiangshu Guo ,&nbsp;Jingyu Li ,&nbsp;Qingchao Zhang ,&nbsp;Eric Tsao","doi":"10.1016/j.biologicals.2025.101852","DOIUrl":"10.1016/j.biologicals.2025.101852","url":null,"abstract":"<div><h3>Objective</h3><div>To compare rabies virus neutralizing antibody (RVNA) kinetics and safety profiles of Zamerovimab and Mazorelvimab monoclonal antibodies (mAbs) versus human rabies immunoglobulin (HRIG) in Category III rabies-exposed patients with heterogeneous wound characteristics.</div></div><div><h3>Methods</h3><div>In this randomized, double-blind, phase III trial, 1000 participants with Category III exposure were stratified into single-wound (n = 735) and multi-wound (n = 265) subgroups. Subjects received either 0.3 mg/kg mAbs (n = 750) or 20 IU/kg HRIG (n = 250) on Day 0, followed by Essen regimen vaccination. RVNA levels were quantified by Rapid Fluorescent Foci Inhibition Test (RFFIT) at 0, 3, 7, 14, and 42 days. Primary endpoints included RVNA geometric mean concentration (GMC), seroconversion rate (RVNA ≥0.5 IU/mL) and incidence of adverse events (AEs).</div></div><div><h3>Results</h3><div>The mAbs-treated subgroups exhibited significantly higher RVNA GMCs than HRIG at early timepoints (e.g., Day 3, single-wound subgroups: 4.552 vs. 0.297 IU/mL; multi-wound subgroups: 4.06 vs. 0.305 IU/mL), achieving over 99.8 % seroconversion by Day 3. The mAbs showed similar or higher RVNA seroconversion rates in multi-wound subgroup compared to single-wound subgroup, while HRIG exhibited lower serum positivity rates. AEs were more common in HRIG recipients across both single-wound and multi-wound subgroups (mAbs: 41.9 %, 42.4 %; HRIG: 55.3 %, 54.8 %). Treatment-related AEs were also higher in HRIG groups (mAbs: 26.3 %, 27.1 %; HRIG: 39.9 %, 48.4 %), particularly in multi-wound subgroups. Most local and systemic AEs were mild to moderate in severity. No suspected rabies cases or deaths occurred through the 365-day study period, and no participants withdrew due to AEs.</div></div><div><h3>Conclusion</h3><div>Zamerovimab and Mazorelvimab achieves earlier and higher RVNA titers than HRIG across diverse wound types, with comparable safety. In multi-wound exposures, mAbs therapy demonstrates superior RVNA seroconversion rate and reduced reactogenicity compared to HRIG, providing robust evidence for its preferential use in high-risk rabies exposures.</div></div><div><h3>Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> #NCT04644484.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101852"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144830571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conference report WHO informal consultation on the draft WHO Guideline on the phasing out of animal tests for the quality control of biological products","authors":"Ian Feavers ,&nbsp;Dianliang Lei ,&nbsp;Catherine Milne ,&nbsp;Ivana Knezevic ,&nbsp;Tiequn Zhou ,&nbsp;Eunkyung Kim","doi":"10.1016/j.biologicals.2025.101862","DOIUrl":"10.1016/j.biologicals.2025.101862","url":null,"abstract":"<div><div>Animal testing has long supported the development and quality control of biotherapeutics and vaccines by ensuring safety and efficacy. However, its variability and time-consuming nature can delay product availability. Advances in non-animal technologies, guided by the 3Rs principles, have led to more efficient and scientifically robust alternatives. Recognizing the limitations of animal assays, WHO encourages their replacement when scientifically justified and has drafted a Guideline on phasing out animal tests in biological product quality control. Following public consultation, an informal meeting at WHO Headquarters brought together regulators, industry representatives, and other stakeholders to review the draft. The Guideline was developed based on ECBS recommendations and a review of existing WHO documents. Participants proposed improvements, including a revised title, to better emphasize the scientific rationale for replacing animal-based tests used in quality control scheme. These updates aim to support finalization of the document for a second public consultation and ECBS adoption.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101862"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145265580","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}