Biologicals最新文献_第4页

Functional characterization of the Clostridium perfringens quadruple point mutant epsilon toxin. 产气荚膜梭菌四点突变体epsilon毒素的功能特征。

IF 1.5 4区生物学

Biologicals Pub Date : 2025-08-01 Epub Date: 2025-08-09 DOI: 10.1016/j.biologicals.2025.101851

Roopa Anandamurthy Hemanth, Mandrira Ramakrishna Namrutha, Suresh Bindu, Awadhesh Prajapati, Revanaiah Yogisharadhya, Nagappa Karabasanavar, Nihar Nalini Mohanty, Mohammed Mudassar Chanda, Sathish Bhadravati Shivachandra

{"title":"Functional characterization of the Clostridium perfringens quadruple point mutant epsilon toxin.","authors":"Roopa Anandamurthy Hemanth, Mandrira Ramakrishna Namrutha, Suresh Bindu, Awadhesh Prajapati, Revanaiah Yogisharadhya, Nagappa Karabasanavar, Nihar Nalini Mohanty, Mohammed Mudassar Chanda, Sathish Bhadravati Shivachandra","doi":"10.1016/j.biologicals.2025.101851","DOIUrl":"10.1016/j.biologicals.2025.101851","url":null,"abstract":"<p><p>Epsilon toxin (Etx) is one of the exotoxins (∼18) secreted by the spore-forming bacterium Clostridium perfringens, which plays a major role in the pathogenesis of enterotoxaemia (ET) leading to sudden death in affected small ruminants. A chemically inactivated toxoid of Etx has been used as a vaccine to control ET in animals. Non-toxic Etx-mutant proteins could potentially be used in the development of efficient immuno-assays and alternative subunit vaccine formulations for the control of ET in animals. In this study, a codon-optimized synthetic quadruple point mutant (Y30A, H106P, H149A, Y196A) of the etx gene of Clostridium perfringens was expressed in Escherichia coli to produce a recombinant protein (331 aa, ∼36 kDa). The rEtx-mutant protein was purified under both non-denaturing and denaturing-renatured conditions using a single-step affinity chromatography and was functionally characterized in vivo and in vitro. A quadruple point mutant of Etx was structurally similar to the wildtype Etx. The rEtx protein was activated by trypsin, and had no toxicity when tested using in vitro and in vivo models. Furthermore, the protein elicited antigen-specific antibodies in mice, rabbit, and guinea pigs. In an indirect ELISA, the rEtx-mutant protein was able to detect specific antibodies in sera from ET-vaccinated sheep.</p>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"91 ","pages":"101851"},"PeriodicalIF":1.5,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144818361","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

A comprehensive review of current diagnostic techniques for Monkeypox virus detection 目前猴痘病毒检测诊断技术的综合综述

IF 1.5 4区生物学

Biologicals Pub Date : 2025-08-01 Epub Date: 2025-05-08 DOI: 10.1016/j.biologicals.2025.101841

Salma Madihi, Abdelouaheb Benani

{"title":"A comprehensive review of current diagnostic techniques for Monkeypox virus detection","authors":"Salma Madihi, 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":"2025-08-01","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}

引用次数: 0

Ultra-high performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS) for simultaneous estimation of residual glyphosate and its metabolite (amino methyl phosphonic acid - AMPA) in various vaccines 超高效液相色谱-串联质谱（UPLC-MS/MS）同时测定多种疫苗中残留草甘膦及其代谢物（氨基甲基膦酸- AMPA）

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-02-25 DOI: 10.1016/j.biologicals.2025.101822

Bharat Shinde , Dadasaheb Patil , Nitin Kadam , Manish Gautam , Kaushik Banerjee , Sunil Gairola , Pooja Doshi

{"title":"Ultra-high performance liquid chromatography with tandem mass spectrometry (UPLC-MS/MS) for simultaneous estimation of residual glyphosate and its metabolite (amino methyl phosphonic acid - AMPA) in various vaccines","authors":"Bharat Shinde , Dadasaheb Patil , Nitin Kadam , Manish Gautam , Kaushik Banerjee , Sunil Gairola , Pooja Doshi","doi":"10.1016/j.biologicals.2025.101822","DOIUrl":"10.1016/j.biologicals.2025.101822","url":null,"abstract":"<div><div>There is growing interest of monitoring of glyphosate (GLYP) and its active metabolite, aminomethylphosphonic acid (AMPA) in pharmaceuticals globally. Vaccines represents an important class of pharmaceuticals for human and veterinary use. In this work, a robust, sensitive and direct ultra-high-performance liquid chromatography coupled with mass spectrometry (UPLC-MS/MS) based method was developed and validated. This method enables simultaneous detection and quantification of GLYP and AMPA using a simple liquid-liquid extraction technique in complex vaccines. In absence of these residuals, the method was validated using spiked standards of GLYP and AMPA in the selected vaccines. The method demonstrated suitable linearity with r<sup>2</sup> > 0.997 over the wide concentration range of 2–50 ng/mL for GLYP and 2–100 ng/mL for AMPA respectively. LOD and LOQ of 0.5 ng/mL and 2 ng/mL for GLYP and AMPA was observed. The method showed precision (RSD of 14 %) and accuracy (83–108 %) in selected vaccines including diphtheria-tetanus-whole cell pertussis-hepatitis B and <em>haemophilus influenzae</em> type B conjugate, diphtheria-tetanus-whole cell pertussis-hepatitis B-<em>haemophilus influenzae</em> type B conjugate and inactivated polio virus, measles-mumps-rubella and pneumococcal polysaccharide conjugate vaccines. The study supports the suitability of the method for simultaneous monitoring of GLYP and AMPA in vaccine formulations.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101822"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143478700","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

Serum reactivity analysis with inactivated GVII-matched vaccine—Payavax G79®: Comparison of B-cell epitopes in NDV-vaccine strains 灭活gvii匹配疫苗- payavax G79®的血清反应性分析：ndv疫苗株b细胞表位的比较

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-01-29 DOI: 10.1016/j.biologicals.2025.101820

Parisa Jamour , Maryam Shafaati , Mostafa Gholizadeh Gigloo , Rasa Sheini Mehrabzadeh , Towhid Mohammadi , Majid Lotfinia , Sanaz Majidi

{"title":"Serum reactivity analysis with inactivated GVII-matched vaccine—Payavax G79®: Comparison of B-cell epitopes in NDV-vaccine strains","authors":"Parisa Jamour , Maryam Shafaati , Mostafa Gholizadeh Gigloo , Rasa Sheini Mehrabzadeh , Towhid Mohammadi , Majid Lotfinia , Sanaz Majidi","doi":"10.1016/j.biologicals.2025.101820","DOIUrl":"10.1016/j.biologicals.2025.101820","url":null,"abstract":"<div><div>The Newcastle Disease Virus (NDV) sub-genotype VII.1.1 is the most common NDV circulating in Iranian poultry farms. It differs genetically and antigenically from the conventional vaccine strains of genotypes I and II. The inactivated vaccines efficiency can be affected by the grade of similarity with circulating viruses. Here, we updated the NDV vaccine using a local circulating virus seed, introduced Payavax G79® as the inactivated bivalent vaccine, and compared the results with serological and phylogenetic characteristics derived from it to different NDV genotype virus vaccines. According to our results, after 25 days post-vaccination, the antibody titer elicited against sub-genotype VII.1.1 was 8.4 log2. In contrast, the antibody titer against apathogenic genotype I (NDV-V4) and lentogenic genotype II (LaSota) was 4.4 log<sub>2</sub> and 4 log2, respectively. Comparing <em>in silico</em> studies of the F protein's discontinued B-cell epitopes, it was found that NDV-GVII, LaSota, and NDV-V4 virus all have seven, four, and eight discontinued B-cell epitopes on the protein's surface. Furthermore, the HN protein surface of NDV-GVII, LaSota, and NDV-V4 virus has four, six, and three discontinued B-cell epitopes, respectively. In summary, the low similarity between NDV genotypes I, II, and the predominant circulating genotype VII (approximately 83–84 %) indicates the need for an updated vaccine seed strain.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101820"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143146579","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

Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions 生物制品检测关键试剂的全球可用性——现状、挑战和可能的解决方案

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-03-22 DOI: 10.1016/j.biologicals.2025.101821

Laura Viviani , Joris Vandeputte , Dean Smith , Emmanuelle Coppens , Kutub Mahmood , Sunil Goel , Esther Wenzel , Le Sun , Catherine Milne , Quinton Meyer , Michelle Rubbrecht , Mic McGoldrick , Carmen Jungbaeck

{"title":"Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions","authors":"Laura Viviani , Joris Vandeputte , Dean Smith , Emmanuelle Coppens , Kutub Mahmood , Sunil Goel , Esther Wenzel , Le Sun , Catherine Milne , Quinton Meyer , Michelle Rubbrecht , Mic McGoldrick , Carmen Jungbaeck","doi":"10.1016/j.biologicals.2025.101821","DOIUrl":"10.1016/j.biologicals.2025.101821","url":null,"abstract":"<div><div>On July 2, 2024, the International Alliance for Biological Standardization (IABS) and Humane Society International (HSI) co-hosted a webinar on the global availability and affordability of critical reagents for vaccine and biologics production. Despite growing support for non-animal testing, significant barriers remain, especially in low-income countries facing financial and supply chain challenges.</div><div>This meeting showcased successful collaborations on reagent production and shared industry and regulatory perspectives. Key barriers included high reagent costs, import complexities, and the limited number of suppliers. Participants stressed the need for tailored risk-based testing, in-house assay validation, and stronger collaboration for standardised testing. The idea of regional hubs in Africa and Southeast Asia for reagent distribution was also discussed to address logistical challenges.</div><div>A central theme was advocating reliance strategies, which promote shared regulatory assessments and resource optimisation, as demonstrated by the EU/EEA OCABR Network activities and South African-European laboratory collaborations. Difficulties facing smaller national control laboratories in meeting international standards were highlighted, along with the need for further innovation in non-animal-derived reagents to address these challenges. Participants stressed the importance of continued global collaboration and adopting reliance practices to improve access to critical reagents and ensure sustainability in biologics testing.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101821"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143681701","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

Corrigendum to “Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean” [Biologicals 90 (2025) 101826] “多种因素影响拉丁美洲和加勒比疫苗开发和生产的技术转让”[生物制品90(2025)101826]的勘误

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-10 DOI: 10.1016/j.biologicals.2025.101830

Nelson Campos , María de los Ángeles Cortés , Tomás A. Pippo , Judit Rius , James Fitzgerald , Andrés Couve

引用次数: 0

Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products 2019冠状病毒病大流行期间的监管变化：对欧盟和巴西生物和生物技术产品法规的比较审查

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-03 DOI: 10.1016/j.biologicals.2025.101827

Priscila Leone Nassur, Fernanda Borges de Almeida, Fernando Lucas Primo

{"title":"Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products","authors":"Priscila Leone Nassur, Fernanda Borges de Almeida, Fernando Lucas Primo","doi":"10.1016/j.biologicals.2025.101827","DOIUrl":"10.1016/j.biologicals.2025.101827","url":null,"abstract":"<div><div>The process for registration of biologic products is lengthy due to the high number of studies and data required by the health authorities. However, with the COVID-19 pandemic, and the urgent need for an alternative, the authorities reduce the time for registering new products with the challenge of maintaining all the necessary reliable standards. The objective of this paper is to compare the regulatory requirements for biologics in Brazil and the European Union in the context of the pandemic and evaluate the background differences in regulations before and after the emergency. The searches were conducted in the databases of EMA and Anvisa and the results were assessed for type of document/product, regulatory scope/process step, effectiveness, and year of publication/update. Both regulators foresaw the route of registration for emergency use and followed international standards, with strict requirements for quality, safety, and efficacy. After the end of the health emergency, while EMA gradually phased out the emergency regulations, Anvisa withdrew them. It was observed that the challenges faced by the Brazilian authority and industries were related to the lack of a centralized health monitoring system. The regulators were overall aligned in the approaches during the pandemic and both had a regulatory emphasis on vaccines but the measures taken after its end differed. The main difference observed was the slower phase-out and the adoption of lessons learned strategy in the EU, which should be learning points for Anvisa if targeting a continuous readiness strategy for health emergencies.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101827"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143761021","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

Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha 人乳头瘤病毒52型病毒样颗粒的表达、纯化及免疫原性研究

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-13 DOI: 10.1016/j.biologicals.2025.101831

Sheila Chairunnisa , Apon Zaenal Mustopa , Budiman Bela , Rosyida Khusniatul Arifah , Rifqiyah Nur Umami , Moh Egy Rahman Firdaus , Nurlaili Ekawati , Herman Irawan , Shasmita Irawan , Maritsa Nurfatwa , Ai Hertati , Sri Swasthikawati , Ela Novianti , Arizah Kusumawati , Huda Salahudin Darusman

{"title":"Expression, purification, and immunogenicity study of human papillomavirus type 52 virus-like particles produced in Hansenula polymorpha","authors":"Sheila Chairunnisa , Apon Zaenal Mustopa , Budiman Bela , Rosyida Khusniatul Arifah , Rifqiyah Nur Umami , Moh Egy Rahman Firdaus , Nurlaili Ekawati , Herman Irawan , Shasmita Irawan , Maritsa Nurfatwa , Ai Hertati , Sri Swasthikawati , Ela Novianti , Arizah Kusumawati , Huda Salahudin Darusman","doi":"10.1016/j.biologicals.2025.101831","DOIUrl":"10.1016/j.biologicals.2025.101831","url":null,"abstract":"<div><div>Human papillomavirus type 52 (HPV 52) infection is epidemiologically predominant in low-middle income countries in South-East Asia and remains a threat for global health. This study aims to assess the immunogenicity of prophylactic vaccine candidate formulated from HPV 52 L1 virus-like particles (VLPs). A codon-optimized and N-terminally truncated HPV 52 L1 gene was cloned using pHIPZ4 plasmid and expressed in <em>Hansenula polymorpha</em>. Protein purification was performed by one-step cation exchange chromatography and was confirmed by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) and Western blot. The VLPs formation was confirmed by transmission electron microscopy (TEM) prior to formulation using AlPO<sub>4</sub> adjuvant and immunization of BALB/c mouse. The mouse sera were analyzed by enzyme-linked immunosorbent assay (ELISA), and green fluorescent protein (GFP) pseudovirion-based neutralization assay was performed for immunogenicity study. The purified HPV 52 L1 protein was successfully assembled into VLPs and showed a recovery yield of 51.76 %. The L1 antigen demonstrated a high antibody titer production, suggesting that the vaccine formulation induced humoral immune response in mouse model. Moreover, the antibody from mouse sera were able to neutralize HPV 52 pseudovirus infections in human embryonic kidney 293 (HEK293) cells. These findings suggest that the production of HPV 52 L1 VLPs using <em>H. polymorpha</em> expression system induces immune response, thus potentially can be developed as alternative HPV vaccine.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101831"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143824533","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

Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report 关于人体挑战研究临床程序、终点和数据稳健性标准化的监管研讨会-利益相关者会议报告。

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-01-17 DOI: 10.1016/j.biologicals.2025.101818

Irina Meln , Victor Cnossen , Nicoletta Corti , Arno Andeweg , Marc Baay , Christopher Chiu , John Coia , Oliver Cornely , Rebecca J. Cox , Dileep Dasyam , Sigrid C.J. De Keersmaecker , Meagan Deming , Joanna Waldock , Othmar G. Engelhardt , Manman Guo , Okba Haj-Ali Saflo , Annefleur Hensen , Rienk Jeeninga , Simon Kolstoe , Oleg Krut , Ingrid M.C. Kamerling

{"title":"Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report","authors":"Irina Meln , Victor Cnossen , Nicoletta Corti , Arno Andeweg , Marc Baay , Christopher Chiu , John Coia , Oliver Cornely , Rebecca J. Cox , Dileep Dasyam , Sigrid C.J. De Keersmaecker , Meagan Deming , Joanna Waldock , Othmar G. Engelhardt , Manman Guo , Okba Haj-Ali Saflo , Annefleur Hensen , Rienk Jeeninga , Simon Kolstoe , Oleg Krut , Ingrid M.C. Kamerling","doi":"10.1016/j.biologicals.2025.101818","DOIUrl":"10.1016/j.biologicals.2025.101818","url":null,"abstract":"<div><div>Inno4Vac, a public-private partnership funded by the IMI2/EU/EFPIA Joint Undertaking (IMI2 JU), brings together academic institutions, SMEs, and pharmaceutical companies to accelerate and de-risk vaccine development. The project has made significant strides in the selection and production of challenge agents for influenza, respiratory syncytial virus (RSV), and toxigenic <em>Clostridioides difficile</em> for controlled human infection model studies (CHIMs). A regulatory workshop held on March 20, 2024, addressed the standardisation of clinical procedures, ethical considerations, endpoints, and data integrity, highlighting the ongoing initiatives related to these CHIMs. Key discussions focused on refining trial protocols to balance statistical power with participant burden, overseen by a data safety monitoring board. The meeting emphasised the importance of harmonizing CHIM protocols to ensure robust, reproducible, and transparent research. Mandatory trial registration and adherence to the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles were recommended to enhance data reuse and scientific value. This report consolidates efforts to standardise CHIM protocols, essential for accelerating therapeutic innovations and advancing global health research.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101818"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016928","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

Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing 牛结核菌素- 3R电位在批效检测中的质谱分析

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-05 DOI: 10.1016/j.biologicals.2025.101825

Elisabeth Balks , Jan-Hendrik Trösemeier , Michael D. Mühlebach , Andreas Reuter

{"title":"Mass spectrometry analysis of bovine tuberculins - 3R potential in batch potency testing","authors":"Elisabeth Balks , Jan-Hendrik Trösemeier , Michael D. Mühlebach , Andreas Reuter","doi":"10.1016/j.biologicals.2025.101825","DOIUrl":"10.1016/j.biologicals.2025.101825","url":null,"abstract":"<div><div>Tuberculin purified protein derivatives (tuberculin PPDs) are heat-treated, protein-enriched products of lysed mycobacteria. Tuberculin PPDs reveal a delayed hypersensitivity in individuals earlier sensitized to mycobacteria and are thereby used to detect tuberculosis. For batch potency testing of tuberculins, the European Pharmacopoeia advises intradermal injection of products into previously sensitized guinea pigs. Batch potency is reflected by the size of the resulting skin lesions as compared to a reference tuberculin. This procedure is quite compromising and results are highly variable, often requiring test repeats. In a proof of concept study, we evaluated the suitability of a combination of liquid chromatography and mass spectrometry (LC-MS<sup>E</sup>) to record qualitative protein profiles of bovine PPD tuberculin concentrates. Six batches of bovine PPD tuberculin concentrates from three manufacturers and the WHO International Standard for PPD of <em>Mycobacterium bovis</em> tuberculin were studied. In total, 35 proteins were identified by LC-MS<sup>E</sup> followed by MS database search. Eight proteins were consistently found in all batches of all bovine tuberculin PPD products. Our results suggest that LC-MS<sup>E</sup> can be used for the analysis of PPD tuberculin concentrates and that it can be further developed in the future into quantitative MS methods for batch analysis, i.e. consistency testing.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101825"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143783633","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