Biologicals最新文献

{"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}

{"title":"Corrigendum to “Vaccination and surveillance for high pathogenicity avian influenza in poultry-current situation and perspectives” [Biologicals 91 (2025) 101840]","authors":"Nancy C. Sajjadi ,&nbsp;Celia Abolnik ,&nbsp;Francesca Baldinelli ,&nbsp;Ian Brown ,&nbsp;Angus Cameron ,&nbsp;J.J. de Wit (Sjaak) ,&nbsp;Madhur Dhingra ,&nbsp;Olivier Espeisse ,&nbsp;Jean Luc Guerrin ,&nbsp;Timm Harder ,&nbsp;Jeremy Ho ,&nbsp;Tze-Hoong Chua ,&nbsp;Khaled Hussein ,&nbsp;Nicholas Lyons ,&nbsp;Isabella Monne ,&nbsp;Yukitake Okamuro ,&nbsp;Damian Tago Pacheco ,&nbsp;Gounalan Pavade ,&nbsp;Nicolas Poncon ,&nbsp;Teguh Yodiantara Prajitno ,&nbsp;Arjan Stegeman","doi":"10.1016/j.biologicals.2025.101858","DOIUrl":"10.1016/j.biologicals.2025.101858","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101858"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144979675","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":"Adjuvant Synergy: Alum and chlorogenic acid enhance Th1 responses and survival in a Salmonella typhimurium challenge model","authors":"Mahtab Pourkamalzadeh,&nbsp;Seyyed Meysam Abtahi Froushani,&nbsp;Abdolgaffar Ownagh","doi":"10.1016/j.biologicals.2025.101864","DOIUrl":"10.1016/j.biologicals.2025.101864","url":null,"abstract":"<div><div>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 <em>Salmonella typhimurium</em> (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 <em>S. typhimurium</em> 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 <em>S. typhimurium</em>. Also, the group receiving the combined adjuvant had a longer survival rate following exposure to the acute dose of <em>S. typhimurium</em> and had a lower bacterial load in the liver when exposed to the subacute dose of <em>S. typhimurium</em> compared to other immunization protocols. Overall,the combined alum and CGA significantly boosted cellular and humoral immunity following HKST immunization.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101864"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145571663","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 “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]","authors":"Silvia M. Becerra-Bayona ,&nbsp;Víctor Alfonso Solarte ,&nbsp;Juan Dario Alviar Rueda ,&nbsp;Claudia L. Sossa\u2028 ,&nbsp;Martha L. Arango-Rodríguez","doi":"10.1016/j.biologicals.2025.101861","DOIUrl":"10.1016/j.biologicals.2025.101861","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101861"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145056330","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(25)00057-0","DOIUrl":"10.1016/S1045-1056(25)00057-0","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"92 ","pages":"Article 101866"},"PeriodicalIF":1.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145736563","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":"Histological and functional exploration of platelet activity post-SARS-CoV-2 vaccination","authors":"Muhammad Zuhair Yusuf ,&nbsp;Tahira Ghulam ,&nbsp;Zuneera Akram ,&nbsp;Syeda Pinar Nasir ,&nbsp;Rena Zaman","doi":"10.1016/j.biologicals.2025.101845","DOIUrl":"10.1016/j.biologicals.2025.101845","url":null,"abstract":"<div><div>The rapid spread of SARS-CoV-2 prompted swift deployment of early-stage vaccines. These vaccines were crucial for controlling the infection, but concerns about adverse effects, particularly thrombotic complications, arose. One major issue was the potential impact of vaccination on platelet activity. Conflicting findings in the literature, caused by differences in methodologies and platelet activation markers, contributed to uncertainty regarding the risk of thrombus formation after vaccination.</div><div>This study aimed to assess platelet activity before and after SARS-CoV-2 vaccination to evaluate thrombotic risk. Platelet function was analysed <em>in vitro</em>, using aggregation assays and histological examinations of platelet spreading. Key metrics, including adhesion, surface area coverage, and actin cytoskeletal changes, were measured upon platelet exposure to fibrinogen. Platelet aggregation was also assessed using agonists, like collagen, ADP, epinephrine, and ristocetin.</div><div>Platelet aggregation was influenced by ADP, epinephrine, and ristocetin in both pre- and post-vaccination samples. Analysis showed reduced platelet adhesion and spread area. However, actin cytoskeletal analysis revealed a post-vaccination increases in stress fibres and actin nodules, attaining a maximal response similar to pre-vaccination levels. The study identified modulation of the platelets to become active, but no significant correlation of platelet activity changes leading to a higher incidence of thrombotic events was found.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101845"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144138154","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 meta-analysis to re-evaluate the sensitivity and specificity of FMDV NSP ELISA tests","authors":"Beyhan Sareyyüpoğlu ,&nbsp;Ozlem Ilk","doi":"10.1016/j.biologicals.2025.101846","DOIUrl":"10.1016/j.biologicals.2025.101846","url":null,"abstract":"<div><div>Foot-and-mouth disease (FMD) serosurveillance is used as one of the disease control instruments. For this goal, it is necessary to differentiate infected animals from the vaccinated ones using non-structural protein (NSP) enzyme-linked immunoassays (ELISA). Various NSP ELISA have been developed. However, their sensitivity and specificity have shown variable results. Therefore, a meta-analysis was conducted to re-evaluate the sensitivity and specificity of these ELISAs. Experimental data were analyzed using R version 4.2.1, employing the rma.mv function in {metafor} package, and the impute covariance_matrix function from the {clubSandwich} package. Commercial kits, the highest sensitivity (0.82, 0.83) and specificity (0.97) were observed in Kit 1 and 3 groups. Differences in performance measures due to animal profiles were not statistically justified. In-house kits, performance measures varied by animal species and NSP protein. Specifically, sensitivity and specificity were lower in pigs (0.62 and 0.81) compared to cattle (0.93 and 0.97) and sheep (0.94 and 0.98) with 3ABC protein. No significant differences were found between sheep and cattle. Additionally, assays using protein 2C showed significantly lower sensitivity and specificity compared to those using protein 3ABC. The highest diagnostic measures were observed in cattle and sheep tested with the 3AB protein, followed by 3B and 3ABC proteins.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101846"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144138153","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":"Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market integration","authors":"Céline Antoine ,&nbsp;David Mackay ,&nbsp;Paul Midtlyng ,&nbsp;Hans P. Kleppen ,&nbsp;Dušan Palić ,&nbsp;Jean-Paul Pirnay ,&nbsp;Damien Thiry ,&nbsp;Etienne Thiry","doi":"10.1016/j.biologicals.2025.101847","DOIUrl":"10.1016/j.biologicals.2025.101847","url":null,"abstract":"<div><div>The emergence of antimicrobial resistance renewed the interest in bacteriophages as complementary interventions to the use of antibiotics in veterinary medicine. The IABS workshop entitled “Avoiding Antimicrobial Resistance: Veterinary Use of Phages for Prevention, Therapy and Control of Bacterial Infections” brought together experts to discuss the scientific, regulatory and commercial challenges involved in bringing phage-based products to market. The biological characteristics of phages require innovative approaches for product development and regulatory approval. Dependent on their actual use, phages could be marketed as veterinary medicinal products, magistral preparations, food additives, or biocides, each classification implying different regulatory requirements and challenges, and none of which were originally intended for phage-based products. The meeting highlighted the need for regulatory harmonization to facilitate market access and allow manufacturers to choose the most appropriate regulatory pathway for their products. Recent EMA and EDQM guidelines offer some flexibility to take into account the biological nature of phages, but concerns remain about the feasibility of manufacturing phage-based products following existing rules for veterinary chemotherapeutants at commercially viable costs. Overcoming these regulatory and financial barriers is essential for the integration of phage therapy as a therapeutic option for control of bacterial infection and disease in veterinary medicine.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101847"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144312960","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":"Vaccination and surveillance for high pathogenicity avian influenza in poultry—current situation and perspectives","authors":"Nancy C. Sajjadi ,&nbsp;Celia Abolnik ,&nbsp;Francesca Baldinelli ,&nbsp;Ian Brown ,&nbsp;Angus Cameron ,&nbsp;Sjaak de Wit ,&nbsp;Madhur Dhingra ,&nbsp;Olivier Espeisse ,&nbsp;Jean Luc Guerrin ,&nbsp;Timm Harder ,&nbsp;Jeremy Ho ,&nbsp;Tze-Hoong Chua ,&nbsp;Khaled Hussein ,&nbsp;Nicholas Lyons ,&nbsp;Isabella Monne ,&nbsp;Yukitake Okamuro ,&nbsp;Damian Tago Pacheco ,&nbsp;Gounalan Pavade ,&nbsp;Nicolas Poncon ,&nbsp;Teguh Yodiantara Prajitno ,&nbsp;Arjan Stegeman","doi":"10.1016/j.biologicals.2025.101840","DOIUrl":"10.1016/j.biologicals.2025.101840","url":null,"abstract":"&lt;div&gt;&lt;div&gt;The International Alliance for Biological Standardization (IABS), in collaboration with the World Organization for Animal Health (WOAH) convened a hybrid meeting on 22–23 October 2024 at the WOAH Headquarters (HQ) in Paris, France to discuss the global state of vaccination and surveillance for high pathogenicity avian influenza (HPAI) in poultry. The primary objective of the meeting was to advance vaccination acceptance to both control virus spread and reduce disease. Vaccination is increasingly recognized as a tool to complement biosecurity, movement controls and stamping-out of infected flocks. However, concerns persist regarding the risk of undetected, sustained transmission (silent infection) in vaccinated flocks as a result of inadequate surveillance. This has contributed to both vaccination hesitancy and trade barriers. The meeting aimed to assess the current state of the art regarding HPAI surveillance programs in vaccinated populations and their effectiveness. Representatives of multiple stakeholders were invited to share their experiences and perspectives on the use of vaccination and accompanying surveillance to control the growing H5N1 panzootic and its global impact. Several conclusions and recommendations emerged as essential to advancing the acceptance of vaccination strategies. These included (1) the utility of quantitative reverse transcriptase polymerase chain reaction (RT-qPCR) as a sensitive, specific and economical tool to detect virus in vaccinated populations, (2) regular testing of dead birds within a flock as a highly effective method for early detection of outbreaks in vaccinated flocks and demonstrating freedom from infection and, (3) the importance of collecting information on circulating field strains in the selection of candidate vaccine antigens to ensure adequate efficacy. Testing sentinel birds was deemed less effective for surveillance and serological testing of vaccinated birds was considered more useful for assessing immunity levels than for determining the infection status of a flock. There was broad agreement on the need to standardize surveillance outcomes in terms of accepted confidence levels to promote safe and fair trade. However, it was acknowledged that context and pragmatic considerations will shape the development of situation specific plans, which must be statistically valid, scientifically sound, economically feasible and operationally sustainable for both governments and industry. Concomitantly, it was recommended that trade policies tied to vaccination and surveillance should be based solely on science and risks. To this end, enforcement of existing international rules and resolution of disputes are considered a shared responsibility. Peer reviewed publications were proposed as a central mechanism for developing the stronger guidelines needed to facilitate fair trade agreements and enable implementation of global vaccination programs. Rapid dissemination of information, consistent messag","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101840"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143937011","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(25)00045-4","DOIUrl":"10.1016/S1045-1056(25)00045-4","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101854"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144866733","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}