Biologicals最新文献_第6页

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 : 2025-02-01 Epub 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":"2025-02-01","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}

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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 : 2025-02-01 Epub Date: 2025-01-09 DOI: 10.1016/S1045-1056(25)00002-8

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 Epub Date: 2024-12-20 DOI: 10.1016/j.biologicals.2024.101777

Elliot Lilley , Richard Isbrucker , Anthony Holmes

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 Epub Date: 2024-11-05 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 Epub Date: 2024-11-19 DOI: 10.1016/S1045-1056(24)00059-9

引用次数: 0

A vision for patient-centric specifications for biologicals 以患者为中心的生物制品规范愿景

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 Epub Date: 2024-10-14 DOI: 10.1016/j.biologicals.2024.101796

Philip Krause, Cristiana Campa, Andrew Chang, Shawn Novick, Barbara Rellahan, Tim Schofield, Dean Smith

引用次数: 0

Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus 评估聚焦还原中和试验和酶联免疫吸附试验与斑块还原中和试验在检测麻疹病毒抗体方面的比较。

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 Epub Date: 2024-10-05 DOI: 10.1016/j.biologicals.2024.101795

Somayeh Yaghoobizad , Zahra Norouzbabaei , Nazanin Zahra Shafiei Jandaghi , Abbas Rahimi Foroushani , Kaveh Sadeghi , Shahrokh Izadi , Ghazal Sadat Fatemi-Nasab , Elaheh Heidari , Vahid Salimi , Talat Mokhtari-Azad

{"title":"Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus","authors":"Somayeh Yaghoobizad , Zahra Norouzbabaei , Nazanin Zahra Shafiei Jandaghi , Abbas Rahimi Foroushani , Kaveh Sadeghi , Shahrokh Izadi , Ghazal Sadat Fatemi-Nasab , Elaheh Heidari , Vahid Salimi , Talat Mokhtari-Azad","doi":"10.1016/j.biologicals.2024.101795","DOIUrl":"10.1016/j.biologicals.2024.101795","url":null,"abstract":"<div><div>Measles is an infectious febrile sickness caused by the measles virus (MeV). Despite an effective vaccine, regional elimination of measles remains a global priority and still faces challenges.</div><div>To estimate community protection against measles, sensitive tests are needed to identify measles-specific antibodies. The enzyme-linked immunosorbent assay (ELISA) is the standard test for assessing immunity but may fail to detect weak antibody responses in vaccinated populations. The plaque reduction neutralization test (PRNT), is the gold standard test for the assessment of protective antibody levels, however, it is not suitable for routine use. This study validated the focus reduction neutralization test (FRNT) as an alternative.</div><div>In eight assay runs, fifty serum samples were analyzed in triplicate using PRNT, FRNT, and ELISA. Data analysis revealed that 38 samples were positive by PRNT, 37 by FRNT, and 19 by ELISA. The results showed that ELISA was not sensitive enough to identify low levels of anti-measles antibodies and showed weak agreement with neutralization assays. In contrast, the two neutralization assays had a perfect correlation and similar sensitivity. FRNT appears to be a suitable alternative to PRNT for characterizing immunological responses and vaccination efficacy.</div><div>Our results highlight the necessity of validating negative and equivocal ELISA results through neutralization methods, during the elimination phases.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"88 ","pages":"Article 101795"},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382539","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

Computational identification of monkeypox virus epitopes to generate a novel vaccine antigen against Mpox 通过计算识别猴痘病毒表位，生成新型猴痘疫苗抗原。

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 Epub Date: 2024-10-30 DOI: 10.1016/j.biologicals.2024.101798

Özge Dülek , Gizem Mutlu , Ecem Su Koçkaya , Hüseyin Can , Muhammet Karakavuk , Aysu Değirmenci Döşkaya , Adnan Yüksel Gürüz , Mert Döşkaya , Cemal Ün

{"title":"Computational identification of monkeypox virus epitopes to generate a novel vaccine antigen against Mpox","authors":"Özge Dülek , Gizem Mutlu , Ecem Su Koçkaya , Hüseyin Can , Muhammet Karakavuk , Aysu Değirmenci Döşkaya , Adnan Yüksel Gürüz , Mert Döşkaya , Cemal Ün","doi":"10.1016/j.biologicals.2024.101798","DOIUrl":"10.1016/j.biologicals.2024.101798","url":null,"abstract":"<div><div>Monkeypox virus (MPXV) belonging to poxviridae family causes chronic viral disease in various mammals including human and monkeys. Conventional vaccines developed against smallpox of poxviridae, are not specific against Mpox. Also, they can cause various side effects after vaccination. In this study, we aimed to analyze the A17L, A28L, A37R, A43R, E8L, H3L, B6R, and M1R structural proteins of MPXV and identify epitopes in them which can be used to generate vaccine antigens. Among the proteins analyzed, the M1R protein was predicted to be more appropriate for use in vaccine research due to its high antigenicity value and other physicochemical features. Also, A17L, B6R and E8L had high antigenicity values. E8L protein was more conserved while the A37R, A43R, and B6R proteins had signal peptides. Although a total of eight B cell epitopes were predicted in all proteins analyzed, CNGETK epitope belonging to B6R protein had the highest antigenicity value (1.7083), as well as was non-allergenic, non-toxic, and soluble. Based on T cell epitope analyses performed on all proteins, fourteen MHC-I/II epitopes were predicted that are antigenic, non-allergenic and non-toxic, as well as soluble. Among them, MHC-I related-HEIYDRNVGF epitope in A28L protein had the highest antigenicity value (1.6650) and MHC-II related-IGNIKIVQIDIRDIK epitope in A37R protein had the highest antigenicity value (2.0280). In conclusion, eight structural proteins of MPXV were successfully analyzed and 22 important epitopes were identified that could serve as vaccine antigens or in serological studies to develop diagnostic tools.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"88 ","pages":"Article 101798"},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549080","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

Collaborative study on the cross-reactivity of two influenza B viral components in single radial immunodiffusion assay using quadrivalent influenza vaccines in Japan from 2015/16 to 2021–22 influenza season 2015/16至2021/22流感季节日本使用四价流感疫苗进行的单径向免疫扩散测定中两种乙型流感病毒成分交叉反应的合作研究

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 Epub Date: 2024-10-31 DOI: 10.1016/j.biologicals.2024.101797

Noriko Shimasaki , Yuichi Harada , Kazuya Nakamura , Hitoshi Takahashi , Kayoko Sato , Tomoko Kuwahara , Masaki Ochiai , Hideki Hasegawa , Shigeyuki Itamura

{"title":"Collaborative study on the cross-reactivity of two influenza B viral components in single radial immunodiffusion assay using quadrivalent influenza vaccines in Japan from 2015/16 to 2021–22 influenza season","authors":"Noriko Shimasaki , Yuichi Harada , Kazuya Nakamura , Hitoshi Takahashi , Kayoko Sato , Tomoko Kuwahara , Masaki Ochiai , Hideki Hasegawa , Shigeyuki Itamura","doi":"10.1016/j.biologicals.2024.101797","DOIUrl":"10.1016/j.biologicals.2024.101797","url":null,"abstract":"<div><div>A quadrivalent influenza vaccine (QIV) has been available in Japan since the 2015/2016 influenza season. Single radial immunodiffusion (SRID) assays are currently used worldwide to measure the hemagglutinin (HA) content of influenza vaccine components because they are simple, accurate, and the regulatory requirement, ensuring consistency in manufacture for the HA content. However, the cross-reactivity of antisera against the two lineages of the influenza B virus (IFVB) may cause inaccurate quantification of HA content in QIVs using the SRID assay. To examine cross-reactivity and develop an appropriate procedure for accurate measurement of vaccine potency, a collaborative study with four Japanese vaccine manufacturers was conducted to measure the HA contents of trivalent influenza vaccines (TIVs) and QIVs by SRID assay with a single and a mixture of reference antigens (refAgs) from each lineage of IFVB for seven influenza seasons from 2015/16 to 2021/22. The cross-reactivity of the two IFVB components in the SRID assay varied depending on the vaccine viruses. Our study demonstrated that it is useful to validate a suitable combination for each refAg and reference antiserum by selecting the combination showing similar HA contents between experimental TIV and QIV before lot release testing.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"88 ","pages":"Article 101797"},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142554080","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

Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines 评估与使用体内和体外疫苗效力测试有关的风险。

IF 1.5 4区生物学

Biologicals Pub Date : 2024-11-01 Epub Date: 2024-10-05 DOI: 10.1016/j.biologicals.2024.101794

Timothy Schofield

{"title":"Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines","authors":"Timothy Schofield","doi":"10.1016/j.biologicals.2024.101794","DOIUrl":"10.1016/j.biologicals.2024.101794","url":null,"abstract":"<div><div>Animal (<em>in vivo</em>) potency tests have been utilized for over a century in support of vaccine development and for quality testing. This is a legacy of the best science at the time of their introduction. Advances in knowledge and technology, however, have provided opportunities to utilize more sensitive assays during development and replace legacy animal tests with <em>in vitro</em> alternatives. This coupled with initiatives such as replacement, reduction, and refinement (the 3-R's) and quality by design (QbD) have brought industry and regulators together in the introduction of advanced vaccine control strategies.</div><div>This article examines historical and current uses of animals in vaccines technical development and control, and their replacement with <em>in vitro</em> alternatives from a risk point of view. An overarching risk is that a vaccine tested with an alternative potency assay fails to protect its target recipient. This can be addressed from the perspective of the assay's association with the vaccine mechanism of action, and the rules used to introduce the vaccine into the patient population (e.g., specifications). Commonly understood concepts such as analytical precision play a role in risk evaluation based on its impact on the sensitivity of a test to detect meaningful product changes caused by variations in manufacture or over a vaccine's shelf life. This should be considered when evaluating solutions such as the reduction of multi-concentration (or dilution) <em>in vivo</em> assays to a single concentration test. While the use of animals in vaccine development will not go away all together, the paradigm must shift from <em>in vivo tests</em> to <em>in vivo models</em>. To help ensure success, principles and practices related to introduction of <em>in vitro</em> alternatives require global collaboration among industry, regulators, pharmacopeias, and supporting organizations.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"88 ","pages":"Article 101794"},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382538","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