IF 2.1 4区生物学

Biologicals Pub Date : 2026-10-22 DOI: 10.1016/j.biologicals.2026.101919

Johannes Charlier, Laetitia Cicchelero, Beatrice Vos, Juerg Baggenstoss, Hervé Poulet, Dieter Vancraeynest, Sven Arnouts

{"title":"From discovery to innovation in animal health: meeting report of the second DIAH conference.","authors":"Johannes Charlier, Laetitia Cicchelero, Beatrice Vos, Juerg Baggenstoss, Hervé Poulet, Dieter Vancraeynest, Sven Arnouts","doi":"10.1016/j.biologicals.2026.101919","DOIUrl":"https://doi.org/10.1016/j.biologicals.2026.101919","url":null,"abstract":"<p><p>The second Discovery to Innovation in Animal Health (DIAH) Conference, held in Bruges, Belgium, brought together academic researchers, start-ups, industry, investors, regulators and funders to accelerate translation of scientific discoveries into veterinary products. The conference highlighted that successful translation requires early alignment between researchers and industry, sustained public-private funding and realistic market assessment. A clear target product profile, target-species proof-of-concept data, preliminary safety information, intellectual property protection, manufacturing plans and early regulatory dialogue were identified as central elements of an investable development package. Companion-animal markets are expanding rapidly in different segments, particularly products for age-related chronic diseases, behavioural disorders, and specialised diagnostics, while livestock innovation remains driven by prevention of infectious disease, antimicrobial and antiparasitic resistance, climate pressures and labour constraints. Emerging technologies presented included digital monitoring and artificial intelligence, alternatives to antimicrobials, novel antiparasitics, monoclonal antibodies and nanobodies, stem-cell and gene therapies, advanced vaccine platforms and mucosal delivery systems. Start-ups are increasingly important sources of innovation, but require credible commercial strategies, realistic valuation, scalable manufacturing and appropriate partnerships. Early engagement mechanisms offered by regulatory agencies can clarify evidence requirements and support development of novel therapies. Overall, DIAH demonstrated that multidisciplinary collaboration, shared terminology and early integration of scientific, regulatory, manufacturing and commercial perspectives are essential to de-risk innovation and deliver impactful animal health solutions.</p>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"96 ","pages":"101919"},"PeriodicalIF":2.1,"publicationDate":"2026-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149247419","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}

引用次数: 0

Assessing consequences of maternal immunization on fetal outcomes - A meeting report. 评估母体免疫对胎儿结局的影响-会议报告。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-10-21 DOI: 10.1016/j.biologicals.2026.101916

Stephen Evans, Flor M Munoz, Steve Black, Kathryn M Edwards, Nick J Andrews, Benjamin Atkins, Madhava Ram Balakrishnan, Marco Cavaleri, Hannah G Davies, Alemayehu Duga, Janet A Englund, Deshayne B Fell, Delyth Jones, Kirsty Le Doare, Gwen Lemey, Shabir Madhi, Souad Mansouri, Solange Milolo Tshilumba, Jezid Miranda, Paulina Morales-Ruiz, Victoria Prudence Nambasa, Hanna Nohynek, Julien Nyombayire, Lidia Oostvogels, David Radley, Annette Regan, Anna C Seale, Katerina Rok Song, James Southern, Jens-Ulrich Stegmann, Marc Baay, Pieter Neels, Frank Vandendriessche

引用次数: 0

Practical screening and monitoring tools for out-of-specification risk in biological products under finite sample sizes 有限样本量下生物制品超规格风险的实用筛选和监测工具。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-08-02 DOI: 10.1016/j.biologicals.2026.101905

Michikazu Tanio, Isao Hamaguchi, Takuo Mizukami

{"title":"Practical screening and monitoring tools for out-of-specification risk in biological products under finite sample sizes","authors":"Michikazu Tanio, Isao Hamaguchi, Takuo Mizukami","doi":"10.1016/j.biologicals.2026.101905","DOIUrl":"10.1016/j.biologicals.2026.101905","url":null,"abstract":"<div><div>Evaluating the risk of out-of-specification (OOS) occurrence before it happens is essential to prevent delays or interruptions in the supply of biological products. This study proposes a practical and quantitative evaluation approach using two indices, S<sub>1</sub> and S<sub>2</sub>, as OOS risk screening and monitoring tools under finite-sample conditions. S<sub>1</sub> evaluates whether the variability of data points in a dataset satisfies a low OOS risk criterion, defined as an acceptable level of inherent variability. S<sub>2</sub> evaluates whether the observed data range remains within the specification limits with a range-proportional safety margin. Monte Carlo simulations based on normal distributions with sample sizes up to 500 demonstrated that S<sub>1</sub> > 1 effectively identified datasets that deviated from the low OOS risk criterion, whereas S<sub>2</sub> > 1 functioned as an early alert indicator that predicted or coincided with OOS occurrences. Regardless of the distribution type, both indices increase by definition as the spread of data points increases, suggesting their potential applicability as practical monitoring tools even for non-normal datasets. The combined use of S<sub>1</sub> and S<sub>2</sub> provides complementary and early warning insights into potential quality deviations and supports proactive quality risk management of biological products.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"95 ","pages":"Article 101905"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148665206","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}

引用次数: 0

Pyrogen testing 2.0: Ethical, evolving and eco-friendly - Implementing safe, rapid, state-of-the-art and sustainable non-animal approaches worldwide. A meeting report 热原检测2.0：道德的，不断发展的和环保的-在全球范围内实施安全，快速，最先进和可持续的非动物方法。会议报告。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-08-06 DOI: 10.1016/j.biologicals.2026.101904

Charton E, Hornik A, Schütte K, Bouzya B, Spreitzer I, Coppens E, Stirling C, Baay M, Viviani L, Manou I

引用次数: 0

Report of the international conference on animal testing replacement for vaccines: A one health view on global outlook and future strategy 动物试验替代疫苗国际会议报告：关于全球前景和未来战略的同一健康观点。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-08-06 DOI: 10.1016/j.biologicals.2026.101903

Laura Viviani, Evelin Balbino, Meenu Batolar, Jay Bolden, Sarawut Boonsuk, Badiaa Bouzya, Mihaela Buda, Jean-Michel Chapsal, Emmanuelle Coppens, Pradip Das, Fitra Delviona, Blaise Descampe, Alan Fauconnier, Sunil Goel, Juliana Gutierrez-Mazariegos, Bernhard Illes, Masaaki Iwaki, Muthusamy Kalaivani, Naree Ketusing, Manjari Lal, Janette Turner

{"title":"Report of the international conference on animal testing replacement for vaccines: A one health view on global outlook and future strategy","authors":"Laura Viviani, Evelin Balbino, Meenu Batolar, Jay Bolden, Sarawut Boonsuk, Badiaa Bouzya, Mihaela Buda, Jean-Michel Chapsal, Emmanuelle Coppens, Pradip Das, Fitra Delviona, Blaise Descampe, Alan Fauconnier, Sunil Goel, Juliana Gutierrez-Mazariegos, Bernhard Illes, Masaaki Iwaki, Muthusamy Kalaivani, Naree Ketusing, Manjari Lal, Janette Turner","doi":"10.1016/j.biologicals.2026.101903","DOIUrl":"10.1016/j.biologicals.2026.101903","url":null,"abstract":"<div><div>The transition toward non-animal methods for vaccine quality control has accelerated in recent years, driven by scientific advances and evolving regulatory expectations. To assess the current status of replacing animal-based methods, international stakeholders from regulatory authorities, industry, and public health institutions convened in Bangkok, Thailand from 2 to 4 December 2025 for the conference “Animal Testing Replacement for Vaccines: A One Health View – Global Outlook and Future Strategy,” organized by Animal-Free Safety Assessment Collaboration and the International Alliance for Biological Standardization. This report synthesizes key discussions from the meeting, including advancements in in vitro potency, safety, and pyrogenicity testing; challenges associated with validation and global regulatory acceptance; access to critical reagents and reference standards; implementation of reliance and work-sharing models; and capacity building for national control laboratories across human and veterinary sectors. Despite recent progress in some areas, significant barriers remain, including fragmented regulatory requirements, limited access to reference standards, and inconsistent validation and implementation pathways across regions and sectors. Collectively, the outcomes underscore the need for coordinated international action to enable broader adoption of scientifically robust, non-animal testing strategies for quality control of vaccines.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"95 ","pages":"Article 101903"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148686854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

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 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-08-21 DOI: 10.1016/S1045-1056(26)00036-9

引用次数: 0

Neutralizing antibodies are not detected against endogenous bacteriophages in their respective host 在它们各自的宿主中没有检测到针对内源性噬菌体的中和抗体。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-07-23 DOI: 10.1016/j.biologicals.2026.101902

Sonam Rastogi, Alka Shukla, Mayank Gangwar, Sudhir Kumar Singh, Manoj Kumar, Deepak Kumar, Vandana Rastogi, Chanda Hemaliya, Gopal Nath

{"title":"Neutralizing antibodies are not detected against endogenous bacteriophages in their respective host","authors":"Sonam Rastogi, Alka Shukla, Mayank Gangwar, Sudhir Kumar Singh, Manoj Kumar, Deepak Kumar, Vandana Rastogi, Chanda Hemaliya, Gopal Nath","doi":"10.1016/j.biologicals.2026.101902","DOIUrl":"10.1016/j.biologicals.2026.101902","url":null,"abstract":"<div><h3>Introduction</h3><div>Bacteriophages are increasingly recognized as vital modulators of the human microbiome and promising candidates for alternative antimicrobial therapies. Critics raise concerns about immune neutralization with prolonged use. This study examines the presence of bacteriophages in human body fluids and assesses their interaction with autologous and heterologous serum to evaluate immune neutralization of human phage isolates.</div></div><div><h3>Methods</h3><div>Inactivation and neutralization experiments were conducted by exposing samples to neat serum and complement-inactivated serum for 1 h to assess their ability to inactivate human-origin phages.</div></div><div><h3>Results</h3><div>This finding suggests that autologous bacteriophages from human subjects are recognized as self. These phages were not inactivated by either the complement system or neutralized by either homologous or heterologous antibodies.</div></div><div><h3>Conclusion</h3><div>This finding indicates that endogenous phages may reduce worries that antibody or complement activation could inactivate them. It provides evidence that these phages might bypass antibody- or complement-induced neutralization, thereby strengthening their case for therapeutic use.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"95 ","pages":"Article 101902"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148581244","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}

引用次数: 0

Development of a novel competitive ELISA method for Typhoid Vi Polysaccharide Quantitation 一种新型竞争性ELISA法测定伤寒病毒多糖含量。

IF 2.1 4区生物学

Biologicals Pub Date : 2026-08-01 Epub Date: 2026-08-06 DOI: 10.1016/j.biologicals.2026.101906

Ashwani Kumar Mandyal, Rajasekaran Angannan, Balananda Dhurjati Kumar Putcha, Charles David, Tarun Sharma

{"title":"Development of a novel competitive ELISA method for Typhoid Vi Polysaccharide Quantitation","authors":"Ashwani Kumar Mandyal, Rajasekaran Angannan, Balananda Dhurjati Kumar Putcha, Charles David, Tarun Sharma","doi":"10.1016/j.biologicals.2026.101906","DOIUrl":"10.1016/j.biologicals.2026.101906","url":null,"abstract":"<div><div>Licensed typhoid vaccines contain Vi polysaccharide (ViPS), a capsular antigen of <em>Salmonella. Typhi</em> (S.typhi), either unconjugated or conjugated to carrier proteins like tetanus toxoid (TT), diphtheria toxoid (DT), and Cross-reactive material 197 (CRM-<sub>197</sub>). Quantitation of ViPS during vaccine development, is challenging, as ViPS demonstrates limited adsorption to solid phases, resulting in poor binding and reduced sensitivity in conventional ELISA formats. We developed a novel competitive enzyme-linked immunosorbent assay (c-ELISA) using biotinylated ViPS as a detector probe for ViPS quantitation. The performance of c-ELISA with a novel Biotinylation approach was evaluated with WHO recommended orthogonal colorimetry based Hestrin assay and High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method. Both c-ELISA and HPAEC-PAD demonstrated comparable specificity, accuracy and repeatability, however c-ELISA showed a higher sensitivity than HPAEC-PAD in the estimation of unconjugated polysaccharide (free-PS) in typhoid conjugates with a range of 90-10,000 ng/ml. Overall, the newly developed c-ELISA is a reliable and sensitive immunochemical method for the quantification of ViPS, which complements the HPAEC-PAD. Together, these tests can serve as orthogonal analytical platforms for the monitoring of the ViPS during the production of typhoid vaccines and for the quality control.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"95 ","pages":"Article 101906"},"PeriodicalIF":2.1,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148686747","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}

引用次数: 0

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

Biologicals Pub Date : 2026-05-01 Epub 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

Biologicals Pub Date : 2026-05-01 Epub Date: 2026-05-07 DOI: 10.1016/S1045-1056(26)00016-3

引用次数: 0

Biologicals最新文献