Biologicals最新文献

An alternative In vitro method for evaluation of inactivated infectious bronchitis (IB) vaccines

IF 1.5 4区生物学

Biologicals Pub 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":"2025-04-04","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

Regulatory changes during the Covid-19 pandemic: A comparative review of the European Union and Brazilian regulations for biological and biotechnological products

IF 1.5 4区生物学

Biologicals Pub 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":"2025-04-03","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

Validation of a Next Generation Sequencing Method for adventitious agents detection in a live vaccine matrix

IF 1.5 4区生物学

Biologicals Pub 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":"2025-04-02","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

Multiple factors shape technology transfer for the development and manufacture of vaccines in Latin America and the Caribbean

IF 1.5 4区生物学

Biologicals Pub 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":"2025-03-23","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

Global availability of critical reagents for biologicals testing - Current status, challenges and possible solutions

IF 1.5 4区生物学

Biologicals Pub 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":"2025-03-22","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

Development and optimization of multiplex PCR for rapid detection of type I-F1 and type I-F2 Cas cluster genes in Acinetobacter baumannii

IF 1.5 4区生物学

Biologicals Pub 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":"2025-03-13","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

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

IF 1.5 4区生物学

Biologicals Pub 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":"2025-02-25","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

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

IF 1.5 4区生物学

Biologicals Pub 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":"2025-02-23","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

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 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 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