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Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Summary of NC3Rs final report to WHO Expert Committee for Biological Standardisation 将3Rs方法纳入世卫组织生物制品批量放行检测指南：提交世卫组织生物标准化专家委员会的NC3Rs最终报告摘要

IF 1.5 4区生物学

Biologicals Pub Date : 2025-02-01 DOI: 10.1016/j.biologicals.2024.101778

Elliot Lilley , Richard Isbrucker , Anthony Holmes

{"title":"Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Summary of NC3Rs final report to WHO Expert Committee for Biological Standardisation","authors":"Elliot Lilley , Richard Isbrucker , Anthony Holmes","doi":"10.1016/j.biologicals.2024.101778","DOIUrl":"10.1016/j.biologicals.2024.101778","url":null,"abstract":"<div><div>A recently published report from the UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) has highlighted significant opportunities for the broader inclusion of 3Rs approaches (i.e. Replacement, Reduction and Refinement of animal tests) within World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biotherapeutics. The report is the culmination of a three-year project, co-funded by the Bill & Melinda Gates Foundation, to review the extent to which animal-based testing methods are described in WHO manuals, guidelines and recommendations. The aim was to identify where recommendations did not incorporate current non-animal testing strategies and/or 3Rs principles in biologicals quality control and batch release testing. The inclusion of such methods in WHO guidance documents would improve their adoption by regulators and help to accelerate the safe release of these products to the communities who need them most. The final report was presented to the WHO's Expert Committee on Biological Standardization (ECBS) in October 2023 for their consideration and response. The project findings and recommendations described in the report are summarised in this article.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"89 ","pages":"Article 101778"},"PeriodicalIF":1.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873499","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

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Reports from a series of NC3Rs stakeholder workshops 将3Rs方法纳入世卫组织生物制品批量放行检测指南：一系列NC3Rs利益攸关方研讨会的报告

IF 1.5 4区生物学

Biologicals Pub Date : 2025-02-01 DOI: 10.1016/j.biologicals.2024.101777

Elliot Lilley , Richard Isbrucker , Anthony Holmes

引用次数: 0

Aims and Scope/Editorial Board/Publishing Details

IF 1.5 4区生物学

Biologicals Pub Date : 2025-02-01 DOI: 10.1016/S1045-1056(25)00002-8

引用次数: 0

Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA

IF 1.5 4区生物学

Biologicals Pub Date : 2025-01-31 DOI: 10.1016/j.biologicals.2025.101819

Zeinab Behroozi , Danesh Hassani , Maryam Mobini, Tannaz Bahadori, Kiana Peyghami, Mohammad Ali Judaki, Jalal Khoshnoodi, Mohammad Mehdi Amiri, Forough Golsaz-Shirazi, Fazel Shokri

{"title":"Production and characterization of monoclonal antibodies against hepatitis B e-antigen and their potential application for development of HBeAg detection ELISA","authors":"Zeinab Behroozi , Danesh Hassani , Maryam Mobini, Tannaz Bahadori, Kiana Peyghami, Mohammad Ali Judaki, Jalal Khoshnoodi, Mohammad Mehdi Amiri, Forough Golsaz-Shirazi, Fazel Shokri","doi":"10.1016/j.biologicals.2025.101819","DOIUrl":"10.1016/j.biologicals.2025.101819","url":null,"abstract":"<div><div>Despite global vaccination efforts, hepatitis B virus (HBV) infection remains a major health threat, causing over a million deaths annually. Hepatitis B e-antigen (HBeAg) is an indicator of HBV replication and high infectivity. HBeAg is an essential serological marker for monitoring response to treatment and/or determining the stage of chronic HBV infection. Here, we produced a panel of mouse hybridomas secreting monoclonal antibodies (MAbs) to HBeAg by fusing a mouse myeloma cell line with splenocytes from mice immunized with recombinant HBeAg. Anti-HBe MAbs were then characterized by competition ELISA and Western blotting. We designed and optimized an in-house sandwich ELISA using HBeAg-specific rabbit polyclonal and mouse monoclonal antibodies. The diagnostic performance of the assay was then compared to a commercial HBeAg detection ELISA kit using 176 HBeAg[-] and 44 HBeAg[+] serum samples, showing a significant positive correlation (r = 0.8250; P < 0.0001). The in-house ELISA showed reasonable sensitivity (97.56 %) and specificity (99.40 %), with a cut-off value and area under the curve of 0.193 and 0.9884, respectively. Additionally, the assay showed high repeatability, with intra- and inter-assay coefficients of variation of 2.46 % and 11.38 %, respectively. Our designed HBeAg-detecting sandwich ELISA has the potential for use in clinical diagnosis.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101819"},"PeriodicalIF":1.5,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143076640","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

IF 1.5 4区生物学

Biologicals Pub 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":"2025-01-29","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

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 : 2025-01-17 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":"2025-01-17","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

The impact of LPS mutants on endotoxin masking in different detection systems 不同检测系统中 LPS 突变体对内毒素掩蔽的影响

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-24 DOI: 10.1016/j.biologicals.2024.101808

Luisa Burgmaier , Stefan Pölt , Meltem Avci-Adali , Johannes Reich

{"title":"The impact of LPS mutants on endotoxin masking in different detection systems","authors":"Luisa Burgmaier , Stefan Pölt , Meltem Avci-Adali , Johannes Reich","doi":"10.1016/j.biologicals.2024.101808","DOIUrl":"10.1016/j.biologicals.2024.101808","url":null,"abstract":"<div><div>Endotoxin masking poses a potential risk to patient safety by rendering endotoxin undetectable. While research often focuses on international endotoxin standards (RSE), the effects of LPS mutants on Low Endotoxin Recovery (LER) are poorly understood. Our study investigated <em>S. minnesota</em> and <em>E. coli</em> mutants with incomplete O-antigen chains (rough LPS) using Limulus amebocyte lysate (LAL), recombinant Factor C (rFC) and the monocyte activation test (MAT). All tested methods detected the mutants, with variations in activity observed. Measurements over time in a common drug formulation (10 mM sodium citrate and 0.05 % (w/v) polysorbate 20) showed different masking kinetics for the mutants using different methods. We were able to show that LAL and rFC have comparable kinetics, whereas MAT showed improved recovery of masked endotoxin. The study showed that the mutation of LPS have an effect on masking, independent of the assay system. We propose that polysaccharide length affects masking susceptibility, with lower hydrophilic/hydrophobic ratios caused by the shortened polysaccharide chain (rough LPS) reducing masking. In addition, the stronger negative charge of the rough mutants increases cation affinity and is suggested to contribute to the stabilisation of supramolecular structures, making the rough mutants less susceptible to masking than the smooth mutants.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"89 ","pages":"Article 101808"},"PeriodicalIF":1.5,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142698940","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

A collaborative study to establish the second national standard for antithrombin concentrate in Korea 为制定韩国第二个抗凝血酶浓缩物国家标准而开展的合作研究。

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-21 DOI: 10.1016/j.biologicals.2024.101807

Su Kyoung Seong , Hyun-Jung Koh , Hyun Jeong Kim , Yoojung Yi , Chan Woong Choi , In Soo Shin , Youngju Choi , Young Hoon Kim

{"title":"A collaborative study to establish the second national standard for antithrombin concentrate in Korea","authors":"Su Kyoung Seong , Hyun-Jung Koh , Hyun Jeong Kim , Yoojung Yi , Chan Woong Choi , In Soo Shin , Youngju Choi , Young Hoon Kim","doi":"10.1016/j.biologicals.2024.101807","DOIUrl":"10.1016/j.biologicals.2024.101807","url":null,"abstract":"<div><div>This study aimed to establish a second national standard for antithrombin (AT) concentrate that can be used for potency assays of AT products. A collaborative study was conducted involving four laboratories, including national control laboratories and manufacturers in Korea, and the suitability of a candidate material to serve as the second national standard for AT concentrate was evaluated. The candidate material was manufactured using a process approved for Good Manufacturing Practices. The potency of the candidate was determined using the heparin cofactor chromogenic method. The candidate was calibrated against the third International Standard for AT concentrate (code 06/166). Participants provided data from 58 independent assays. Combined potency estimates were calculated by determining the geometric means of the results obtained from all assays performed at individual laboratories. The overall potency assessments were subsequently established as the geometric means of all results collected from all laboratories. According to the collaborative study results, the intra- and inter-laboratory variability showed acceptable geometric coefficient of variation of 1.2 %–3.4 % and 2.4 % respectively, and it deemed to serve as the Korean national standard for AT concentrate with the assigned potency as follows: 32.1 IU/vial (95 % confidence interval; 31.7–32.5 IU/vial).</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"89 ","pages":"Article 101807"},"PeriodicalIF":1.5,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693899","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

Advances in mRNA vaccine research in the field of quality control 质量控制领域的 mRNA 疫苗研究进展

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 DOI: 10.1016/j.biologicals.2024.101799

Daomiao Huang , Na Li , Xin Dong

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 : 2024-11-01 DOI: 10.1016/S1045-1056(24)00059-9

引用次数: 0