Biologicals最新文献

{"title":"The past, present and future of blood plasma fractionation","authors":"John Curling ,&nbsp;Albert Farrugia ,&nbsp;Leni von Bonsdorff","doi":"10.1016/j.biologicals.2025.101849","DOIUrl":"10.1016/j.biologicals.2025.101849","url":null,"abstract":"<div><div>Edwin Cohn, appointed to the Harvard Medical School in 1920, was commissioned by the United States military in 1940 to develop a stable albumin solution to treat blood/plasma loss from battlefield injury. Albumin was first produced at the Harvard pilot plant using Cohn's five variable, ethanol precipitation process which was rapidly transferred to private industry for industrial manufacture. For the past decades IgG has been used to treat multiple conditions and has become the industry driver whilst albumin is now a low-price commodity. The development of purification techniques, particularly chromatography, spurred the manufacture of coagulation factors for haemophilia and other proteins from Cohn fractions, leading to the current, unique roster of multiple, essential, plasma-derived medicines. The major cost in fractionation is for plasma, making recombinant and other non-factor alternatives a challenge for the industry. Plasma-derived haemophilia therapies are largely redundant in Western economies, although other products, including prothrombin complex, alpha-1 anti-trypsin, fibrin sealant, provide essential treatments. The established industry is also challenged by potential alternatives to IgG. Despite the plethora of alternative manufacturing technologies, Cohn fractionation in combination with “upstream” harvesting of other proteins through other technologies and “downstream processes” which incorporate unit operations for virus safety is the global industry standard.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101849"},"PeriodicalIF":1.5,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144502735","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":"Establishing potency and stability release specifications using alternative ATP assay of BCG Tokyo 172-1 vaccine used in Thailand","authors":"Supaporn Phumiamorn,&nbsp;Sukanlayanee Chaimee,&nbsp;Wereyamarst Jareankunathum,&nbsp;Assajun Amen,&nbsp;Sompong Sapsutthipas,&nbsp;Wipawee Wongchana","doi":"10.1016/j.biologicals.2025.101848","DOIUrl":"10.1016/j.biologicals.2025.101848","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144472396","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":"2025-06-19","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":"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":"2025-05-27","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":"2025-05-26","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":"Molecular characteristics of feline coronavirus in South Korea, 2016–2023","authors":"Sung-Hee Kim,&nbsp;Kyoung-Ki Lee,&nbsp;Ilseob Lee,&nbsp;Go-Eun Shin,&nbsp;Ji-Ung Jang,&nbsp;Yoon-A Joo,&nbsp;Kyunghyun Lee,&nbsp;Ah-Young Kim,&nbsp;Bok-Kyung Ku,&nbsp;Hye-Young Jeoung","doi":"10.1016/j.biologicals.2025.101844","DOIUrl":"10.1016/j.biologicals.2025.101844","url":null,"abstract":"<div><div>Feline coronavirus is highly contagious and ubiquitous in cat populations. FCoV is classified into two serotypes, types I and II, each including two biotypes, feline enteric coronavirus (FECV) and feline infectious peritonitis virus (FIPV)In this study, FCoV detected in samples collected by the Animal and Plant Quarantine Agency from 2016 to 2023, and analyzed genetic diversity of FCoV for currently circulation in Korea. In a total of 925 cats, FCoV was detected in 294 cats (31.8 %). Among the 73 cases with a final diagnosis, 47.9 % (35/73) were finally found to be FIPV, and 52.1 % (38/73) were confirmed to be FECV. Of the 294 FCoV-positive cases, 24 partial S genes were successfully sequenced. Partial S2 subunit sequencing indicated that types I and II accounted for 91.7 % (22/24) and 8.3 % (2/24) of the cases, respectively. One case, 23D103, contained a different six-nucleotide deletion in the S gene. Phylogenetic analysis of types I and II showed clear discrimination based on the S gene. Types I and II also exhibited 63.2–99.8 % nucleotide acid homology with the S gene of the reference strains. This study provides updated information regarding the current infection status and molecular characteristics of FCoV in Korea.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101844"},"PeriodicalIF":1.5,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144115307","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":"2025-05-13","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":"A comprehensive review of current diagnostic techniques for Monkeypox virus detection","authors":"Salma Madihi,&nbsp;Abdelouaheb Benani","doi":"10.1016/j.biologicals.2025.101841","DOIUrl":"10.1016/j.biologicals.2025.101841","url":null,"abstract":"<div><div>Monkeypox (Mpox) is an infectious disease caused by the Monkeypox virus (MPXV), initially confined to Central and Western Africa, but now spreading globally. The clinical manifestations are often atypical in the current Mpox outbreak, in addition to the critical challenges in MPXV typing and the difficulty in reliably distinguishing between clades. Therefore, diagnosing Mpox based on clinical signs and symptoms only can be challenging. Current treatment is not specific to MPXV and primarily involves supportive care and antiviral drugs that inhibit viral DNA synthesis, such as Tecovirimat and Brincidofovir. This review provides a comprehensive overview of current laboratory techniques for MPXV detection, encompassing both direct and indirect diagnostic methods. It highlights recent advancements, evaluates the strengths and limitations of each approach, and proposes innovative strategies to enhance global diagnostic capabilities, including the potential roles of computational drug discovery and immunoinformatics in designing multi-epitope vaccines targeting MPXV and its variants. The most effective measure to control MPXV spread remains vaccination, timely diagnosis, isolation of infected individuals, maintaining personal hygiene, and avoiding contact with contaminated persons, objects, and animal waste.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"Article 101841"},"PeriodicalIF":1.5,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143916769","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 “Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean” [Biologicals 90 (2025) 101826]","authors":"Nelson Campos ,&nbsp;María de los Ángeles Cortés ,&nbsp;Tomás A. Pippo ,&nbsp;Judit Rius ,&nbsp;James Fitzgerald ,&nbsp;Andrés Couve","doi":"10.1016/j.biologicals.2025.101830","DOIUrl":"10.1016/j.biologicals.2025.101830","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101830"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143904471","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)00026-0","DOIUrl":"10.1016/S1045-1056(25)00026-0","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101835"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143904129","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}