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An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines 评估灭活传染性支气管炎（IB）疫苗的另一种体外方法

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-04 DOI: 10.1016/j.biologicals.2025.101829

Saleh E. Ali , Moustafa A. Zaghloul , Amina A. Radwan , Maha M. Sayed , Hala A. Said , Hanaa A. Moustafa , Osama Alaidi

{"title":"An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines","authors":"Saleh E. Ali , Moustafa A. Zaghloul , Amina A. Radwan , Maha M. Sayed , Hala A. Said , Hanaa A. Moustafa , Osama Alaidi","doi":"10.1016/j.biologicals.2025.101829","DOIUrl":"10.1016/j.biologicals.2025.101829","url":null,"abstract":"<div><div>We report a rapid <em>in vitro</em> method for the potency evaluation of oil-based inactivated Infectious Bronchitis virus (IBV) vaccines. The method is designed to be used by both, quality control laboratories during vaccine manufacturing and by authorizing national laboratories. The simple technique reduces the time and the number of live birds needed for vaccine potency evaluation, effectively promoting a clean environment. Further, the method is a convenient alternative to using the traditional vaccine potency test in which live animals are used. To illustrate a proof of concept, antigens from a total of ten commercial oil adjuvant infectious bronchitis vaccines from different manufacturers were chemically extracted using isopropyl myristate and an antigen capture ELISA test was used to quantify the antigen concentration in the aqueous extracts. The results from the conventional live birds’ tests, which determine the antibody titers after 3–4 weeks postvaccination, were compared to their corresponding antigen concentrations obtained by capture ELISA. The results indicate that, vaccines that contain a threshold amount of the specific IBV antigen (here determined to be > 1.26 pg/dose based on an antigen capture ELISA method), can be considered potent without the need to further test in live animals, provided that the concentration of the antigen can be reliably measured in its aqueous phase extract. Moreover, a linear relation between the antigen amount per dose and the antibody titer was found. Overall, the developed methods in this study are suited for high throughput vaccine potency evaluation.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101829"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143767755","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

Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii 快速检测鲍曼不动杆菌I-F1型和I-F2型Cas簇基因的多重PCR方法的建立与优化

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-03-13 DOI: 10.1016/j.biologicals.2025.101824

Gulshan Yadav , Amit Sharma , Umesh Prasad Sah Hathi , Rajni Gaind , Ruchi Singh

{"title":"Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii","authors":"Gulshan Yadav , Amit Sharma , Umesh Prasad Sah Hathi , Rajni Gaind , Ruchi Singh","doi":"10.1016/j.biologicals.2025.101824","DOIUrl":"10.1016/j.biologicals.2025.101824","url":null,"abstract":"<div><div>Polymerase chain reaction (PCR), especially the multiplex PCR assay, enables simultaneous detection of multiple genes and is highly effective for diagnostic applications. The CRISPR-associated (Cas) system consists of several genes, and complete gene clusters are essential for its activity; multiplex PCR is an excellent method for detecting these multiple genes. This study focuses on the development and validation of a multiplex PCR protocol for the specific detection of CRISPR-Cas subtypes I-F1 and I-F2 found in <em>A. baumannii</em>, which is classified as a critical ESKAPE pathogen. The multiplex PCR method achieved a 100 % detection rate for isolates containing Cas subtypes I-F1 and I-F2 in clinical <em>A. baumannii</em> isolates. Testing across various genera and <em>Acinetobacter</em> species confirmed the high specificity of the assay, with no false positives, establishing it as a reliable tool for large-scale clinical applications. Of the 96 clinical <em>A. baumannii</em> isolates analysed, 29.167 % (n = 28) were multiplex PCR positive for a CRISPR-Cas system. Among these, 71.43 % (n = 20) had subtype I-F1, while 28.57 % (n = 8) had subtype I-F2. No clear association was found between Cas subtypes and resistance to the tested antibiotics or carbapenem genes. This study provides a valuable tool for monitoring CRISPR-Cas systems and can aid in various experimental and novel strategies to manage multidrug-resistant <em>A. baumannii</em>.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101824"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143619184","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

Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean 多种因素影响着拉丁美洲和加勒比疫苗开发和生产的技术转让

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-03-23 DOI: 10.1016/j.biologicals.2025.101826

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

{"title":"Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean","authors":"Nelson Campos , María de los Ángeles Cortés , Tomás A. Pippo , Judit Rius , James Fitzgerald , Andrés Couve","doi":"10.1016/j.biologicals.2025.101826","DOIUrl":"10.1016/j.biologicals.2025.101826","url":null,"abstract":"<div><div>The COVID-19 pandemic highlighted significant inequalities in access to medicines and emergency supplies, including vaccines, that persist in Latin America and the Caribbean. From a regional perspective, it is necessary to improve the conditions to ensure more equitable and inclusive access to health technologies, both in normal scenarios and during future biological threats. Technology Transfer emerges as an effective tool to permanently avoid scarcity in global and regional vaccine supplies.</div><div>Here we describe the global and regional ecosystem of Technology Transfer, its actors, roles, interactions, and evolution through research of publicly available documents and interviews with experts from the region and international institutions. Additionally, we identify and analyze vaccine projects, characterize typologies of projects in the region, suggest an evolution of three temporal phases, reveal lessons from the COVID-19 pandemic and identify four drivers that expedite vaccine Technology Transfer in Latin America and the Caribbean. These drivers include (i) strengthening of regulatory capacities for vaccines; (ii) adoption of trade standards; (iii) increasing manufacture capacity, R&D, and human resources; and (iv) consideration of aggregated demand.</div><div>Finally, we present recommendations to maximize the potential of scientific-technological and vaccine production capacities in Latin American and the Caribbean. They relate to the four drivers, the promotion of complementary industries, data access and availability policies, inter-institutional dialogue and coordination, public health considerations, and future work in areas of information opacity.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101826"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143681696","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

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 : 2025-05-01 Epub Date: 2025-05-05 DOI: 10.1016/S1045-1056(25)00026-0

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 乙型肝炎e抗原单克隆抗体的制备、鉴定及其在HBeAg检测ELISA中的潜在应用

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub 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":"2025-05-01","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

Report of the Ninth Asian National Control Laboratory Network meeting in 2024, with a focus on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma 2024年第九届亚洲国家控制实验室网络会议报告，重点是区域协调监管系统，为血浆跨境转移做好准备

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-02-23 DOI: 10.1016/j.biologicals.2025.101823

Chan Woong Choi , Youngju Choi , Yuyun Siti Maryuningsih , Jin Ho Shin , Piyamaporn Chantarasomchin , Takuo Mizukami , Siaw Wee Ng , Dung Luu Thi , Dio Ramondrana , Geraldine N. Dimapilis , Kyung Hee Sohn , Hang Sik Roh , Hyun Jung Koh , Wonjong Lee , Young Hoon Kim

{"title":"Report of the Ninth Asian National Control Laboratory Network meeting in 2024, with a focus on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma","authors":"Chan Woong Choi , Youngju Choi , Yuyun Siti Maryuningsih , Jin Ho Shin , Piyamaporn Chantarasomchin , Takuo Mizukami , Siaw Wee Ng , Dung Luu Thi , Dio Ramondrana , Geraldine N. Dimapilis , Kyung Hee Sohn , Hang Sik Roh , Hyun Jung Koh , Wonjong Lee , Young Hoon Kim","doi":"10.1016/j.biologicals.2025.101823","DOIUrl":"10.1016/j.biologicals.2025.101823","url":null,"abstract":"<div><div>The National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety in Korea, organized and hosted the 2024 Asian National Control Laboratory (NCL) Network meeting which focussed on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma. The meeting brought together representatives from seven World Health Organization (WHO) member states, along with experts from the WHO, the WHO Regional Office for the Western Pacific, and Thailand Institute of Biological Products, for special lectures. Key topics included considerations for cross-border plasma transfers for fractionation, ensuring the safety of blood and blood products in the Western Pacific region, and the current status of local plasma-derived medicinal products (PDMPs) production in Thailand. Participating countries also shared their latest experiences and updates on national lot release and biological standardization activities. All participants emphasized the need for ongoing coordination among Asian NCLs to address the increasing movement of plasma across borders and the growing demand for PDMPs in Asia. The meeting concluded with agreements to strengthen regulatory capacities and enhance cooperation among Asian NCLs, with WHO playing a central role in supporting these efforts.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101823"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143471489","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

Validation of a Next Generation Sequencing Method for adventitious agents detection in a live vaccine matrix 在活疫苗基质中检测不定因子的新一代测序方法的验证

IF 1.5 4区生物学

Biologicals Pub Date : 2025-05-01 Epub Date: 2025-04-02 DOI: 10.1016/j.biologicals.2025.101828

Alice Alston , Rebecca A. Bova , Bradley Hasson

{"title":"Validation of a Next Generation Sequencing Method for adventitious agents detection in a live vaccine matrix","authors":"Alice Alston , Rebecca A. Bova , Bradley Hasson","doi":"10.1016/j.biologicals.2025.101828","DOIUrl":"10.1016/j.biologicals.2025.101828","url":null,"abstract":"<div><div>Next Generation Sequencing (NGS) has proven itself as a suitable replacement technology for traditional viral safety assessment assays in the manufacturing of complex biologics. Most notably, its incorporation into ICH Q5A(R2) in November 2023 endorses the technology platform as a suitable alternative to traditional <em>in vivo</em>, <em>in vitro</em> and PCR-based testing for adventitious viruses based on the risk assessment of the product and its context for use. In addition to the finalization of ICH Q5A(R2), a separate European Pharmacopoeia chapter Ph. Eur. 2.6.41 (High Throughput Sequencing for the Detection of Viral Extraneous Agents) is under review to further outline and provide guidance for the application and validation of NGS-based methodologies. Within the context of avian-based quadrivalent influenza vaccine manufacturing, NGS provides an alternative viral safety assessment method to traditional <em>in vivo</em> based testing models which are requirements for every lot manufactured. However, prior to implementation of NGS alternative methodology for commercial product testing, suitability of the method must be demonstrated within the context of the product through appropriate assay validation.</div><div>In line with ICHQ5A (R2), 3.2.5.2 Next Generation Sequencing, non-targeted NGS can replace <em>In vivo</em> with broad virus detection for unknown or unexpected virus species without a head-to-head comparison. Therefore, complying with ICH Q5A (R2) and also AstraZeneca internal risk assessment for adventitious agents’ detection, a comparability study directly comparing <em>In vivo</em> to NGS was not completed.</div><div>This article summarizes the collaborative effort between AstraZeneca and MilliporeSigma to replace the <em>in vivo</em> adventitious virus test for Live Attenuated Influenza Vaccine (LAIV) with NGS for broad virus detection as part of a comprehensive virus testing strategy.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"90 ","pages":"Article 101828"},"PeriodicalIF":1.5,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746889","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

Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia 埃塞俄比亚基于DF-1细胞培养的传染性法氏囊病病毒疫苗开发评价

IF 1.5 4区生物学

Biologicals Pub Date : 2025-02-01 Epub Date: 2024-12-26 DOI: 10.1016/j.biologicals.2024.101809

Ayalew Negash Shiferaw , Babasola Oluseyi Olugasa , Tedros Fikru Teshome , Esayas Gelaye , Molalegne Bitew

{"title":"Evaluation of DF-1 cell culture based vaccine development for infectious bursal disease virus in Ethiopia","authors":"Ayalew Negash Shiferaw , Babasola Oluseyi Olugasa , Tedros Fikru Teshome , Esayas Gelaye , Molalegne Bitew","doi":"10.1016/j.biologicals.2024.101809","DOIUrl":"10.1016/j.biologicals.2024.101809","url":null,"abstract":"<div><div>Infectious Bursal Disease is a highly contagious, immunosuppressive viral disease of young chicks caused by the Infectious Bursal Disease Virus (IBDV). The study was carried out at the National Veterinary Institute (NVI) of Ethiopia to evaluate the competence of the DF-1 cell culture adapted vaccine strain of IBDV as a vaccine candidate. DF-1 cells at passage 27 confluent monolayer was infected with 1 ml of LC-75 vaccine strain virus by adsorption method and recorded as passage 1 (P<sub>1</sub>). This procedure has been repeated up to seven serial passages with the same methods of virus infection onto DF-1 cells. Minor CPEs were observed in the second passage, but vivid cytopathic effects (CPE) were observed starting from passage 3 (P<sub>3</sub>). The infectivity titer of DF-1 cell adapted virus was determined, and the results showed a linear increase in titer with each passage number. Transcriptase polymerase chain reaction (RT-PCR) targeting the VP2 gene revealed positive 400-base pair amplification. The vaccinated experimental chicks from passages 5 and 7 and the CFC based vaccine showed no clinical signs and/or death. Efficacy test revealed that DF-1 adapted vaccinal strain protected the chicks from the challenged virus strain at passage 5 and 7. The control group, on the other hand, had 100 % morbidity and 91 % mortality. As a result, the DF-1 cell could be used as a model to study IBDV kinetic growth, and the DF-1 cell adapted virus could be a candidate for IBD vaccine development. Thus, IBD vaccine production using DF-1 cells is recommended.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"89 ","pages":"Article 101809"},"PeriodicalIF":1.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142900644","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

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 Epub Date: 2024-12-20 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

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