Altex-Alternatives To Animal Experimentation最新文献_第4页

Development of a monoclonal antibody sandwich ELISA for the quality control of human and animal tetanus vaccines. 开发用于人类和动物破伤风疫苗质量控制的单克隆抗体夹心酶联免疫吸附试验。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 Epub Date: 2024-08-23 DOI: 10.14573/altex.2401171

Laura Hassall, Daniel A Yara, Rebecca Riches-Duit, Peter Rigsby, Alexandre Dobly, Maxime Vermeulen, Antoine Francotte, Bart Faber, Paul Stickings

{"title":"Development of a monoclonal antibody sandwich ELISA for the quality control of human and animal tetanus vaccines.","authors":"Laura Hassall, Daniel A Yara, Rebecca Riches-Duit, Peter Rigsby, Alexandre Dobly, Maxime Vermeulen, Antoine Francotte, Bart Faber, Paul Stickings","doi":"10.14573/altex.2401171","DOIUrl":"10.14573/altex.2401171","url":null,"abstract":"Antigen identity, quantity and integrity are key factors to be evaluated as part of consistency testing of tetanus vaccines. Here we have developed a monoclonal antibody sandwich ELISA to measure the relative amount and quality of tetanus toxoid (TTxd) in human and animal tetanus vaccines. The ELISA is highly specific, has good dilutional linearity, and is suitable for detecting TTxd in a range of different products. We have demonstrated the ability of the assay to discriminate between batches of different content, using vaccine batches that had been prepared to contain differing amounts of TTxd, and of different quality, using samples of non-adjuvanted TTxd that had been exposed to sonication and final lot vaccines that had been exposed to heat or oxidative stress. We have also demonstrated successful transfer of the method to other laboratories and have shown that different tetanus antigen materials may be able to serve as a reference antigen for standardization of the method. The results show this test has the potential to play a key role in a control strategy no longer including an in vivo potency test.","PeriodicalId":51231,"journal":{"name":"Altex-Alternatives To Animal Experimentation","volume":" ","pages":"588-604"},"PeriodicalIF":4.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142127267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Revolutionizing developmental neurotoxicity testing - a journey from animal models to advanced in vitro systems. 革命性的发育神经毒性测试--从动物模型到先进体外系统的历程。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 Epub Date: 2024-04-06 DOI: 10.14573/altex.2403281

Lena Smirnova, Helena T Hogberg, Marcel Leist, Thomas Hartung

{"title":"Revolutionizing developmental neurotoxicity testing - a journey from animal models to advanced in vitro systems.","authors":"Lena Smirnova, Helena T Hogberg, Marcel Leist, Thomas Hartung","doi":"10.14573/altex.2403281","DOIUrl":"10.14573/altex.2403281","url":null,"abstract":"Developmental neurotoxicity (DNT) testing has seen enormous progress over the last two decades. Preceding even the publication of the animal-based OECD test guideline for DNT testing in 2007, a series of non-animal technology workshops and conferences that started in 2005 has shaped a community that has delivered a comprehensive battery of in vitro test methods (DNT IVB). Its data interpretation is now covered by a very recent OECD guidance (No. 377). Here, we overview the progress in the field, focusing on the evolution of testing strategies, the role of emerging technologies, and the impact of OECD test guidelines on DNT testing. In particular, this is an example of the targeted development of an animal-free testing approach for one of the most complex hazards of chemicals to human health. These developments started literally from a blank slate, with no proposed alternative methods available. Over two decades, cutting-edge science enabled the design of a testing approach that spares animals and enables throughput to address this challenging hazard. While it is evident that the field needs guidance and regulation, the massive economic impact of decreased human cognitive capacity caused by chemical exposure should be prioritized more highly. Beyond this, the claim to fame of DNT in vitro testing is the enormous scientific progress it has brought for understanding the human brain, its development, and how it can be perturbed.","PeriodicalId":51231,"journal":{"name":"Altex-Alternatives To Animal Experimentation","volume":"41 2","pages":"152-178"},"PeriodicalIF":4.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140861361","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

E-validation - Unleashing AI for validation. 电子验证--利用人工智能进行验证。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2409211

Thomas Hartung, Alexandra Maertens, Thomas Luechtefeld

{"title":"E-validation - Unleashing AI for validation.","authors":"Thomas Hartung, Alexandra Maertens, Thomas Luechtefeld","doi":"10.14573/altex.2409211","DOIUrl":"https://doi.org/10.14573/altex.2409211","url":null,"abstract":"The validation of new approach methods (NAMs) in toxicology faces significant challenges, including the integration of diverse data, selection of appropriate reference chemicals, and lengthy, resource-intensive consensus processes. This article proposes an artificial intelligence (AI)-based approach, termed e-validation, to optimize and accelerate the NAM validation process. E-vali-dation employs advanced machine learning and simulation techniques to systematically design validation studies, select informative reference chemicals, integrate existing data, and provide tailored training. The approach aims to shorten current decade-long validation timelines, using fewer resources while enhancing rigor. Key components include the smart selection of reference chemicals using clustering algorithms, simulation of validation studies, mechanistic validation powered by AI, and AI-enhanced training for NAM education and implementation. A centralized dashboard interface could integrate these components, streamlining workflows and providing real-time decision support. The potential impacts of e-validation are extensive, promising to accel-erate biomedical research, enhance chemical safety assessment, reduce animal testing, and drive regulatory and commercial innovation. While the integration of AI and machine learning offers sig-nificant advantages, challenges related to data quality, complexity of implementation, scalability, and ethical considerations must be addressed. Real-world validation and pilot studies are crucial to demonstrate the practical benefits and feasibility of e-validation. This transformative approach has the potential to revolutionize toxicological science and regulatory practices, ushering in a new era of predictive, personalized, and preventive health sciences.","PeriodicalId":51231,"journal":{"name":"Altex-Alternatives To Animal Experimentation","volume":"41 4","pages":"567-587"},"PeriodicalIF":4.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512490","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Trends in the use of animals and non-animal methods over the last 20 years. 过去 20 年中使用动物和非动物方法的趋势。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2410111

Katy Taylor

{"title":"Trends in the use of animals and non-animal methods over the last 20 years.","authors":"Katy Taylor","doi":"10.14573/altex.2410111","DOIUrl":"https://doi.org/10.14573/altex.2410111","url":null,"abstract":"Despite the importance of the animal testing issue, there has been little presentation in the scientific literature of the trends in animal use. This is crucial to resolve, particularly if we are to measure the impact of initiatives to reduce and replace animal experiments that were recently announced in Europe and the USA. For the first time, the number of animals used between 2002 and 2022 are presented for the EU, key animal-using countries in Europe (the UK, France and Germany), and North America (the USA and Canada). Animal testing is on a slow decrease in the EU, 11% in the last 20 years, but animal use in the UK, France and Germany is at similar levels as it was in 2002. Notably there has been a decrease in the production of genetically altered animals in the UK and a decrease in regulatory testing in the EU. Animal use in Canada has been steadily growing, and figures for the USA are still incomplete as laboratory-bred rodents and some other species are not counted. However, globally, the use of non-animal methods in biomedical research is increasing exponentially; this accelerated in the mid-2010s. The UK appears to be the leader in this field. The technological, regulatory, political and economic factors that might explain these trends are discussed.","PeriodicalId":51231,"journal":{"name":"Altex-Alternatives To Animal Experimentation","volume":"41 4","pages":"503-524"},"PeriodicalIF":4.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142512495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A sensitive cell-based assay for testing potency of botulinum neurotoxin type A 测试 A 型肉毒杆菌神经毒素效力的灵敏细胞检测法。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 Epub Date: 2024-07-22 DOI: 10.14573/altex.2312071

Ceyda Caliskan, Deniz Simsek, Charlotte Leese, Ciara Doran, Elizabeth Seward, Andrew A Peden, Bazbek Davletov

{"title":"A sensitive cell-based assay for testing potency of botulinum neurotoxin type A","authors":"Ceyda Caliskan, Deniz Simsek, Charlotte Leese, Ciara Doran, Elizabeth Seward, Andrew A Peden, Bazbek Davletov","doi":"10.14573/altex.2312071","DOIUrl":"10.14573/altex.2312071","url":null,"abstract":"Botulinum neurotoxin type A (BoNT/A) is a biopharmaceutic widely used for the treatment of neurological diseases and in aesthetic medicine to achieve months-long paralysis of target muscles and glands. Large numbers of mice are used in the mouse bioassay (MBA) for various botulinum-related applications including batch release potency testing, antitoxin testing, countermeasure development, and basic research. BoNT/A intoxication causes severe suffering to the mice used for testing, and application-specific, non-animal alternatives are urgently needed. Cell-based assays (CBA) need to replicate all the physiological steps of botulinum intoxication, comprising neuronal binding, internalization, endosomal escape, and cleavage of synaptosomal-associated protein of 25 kDa (SNAP25). However, the CBA currently in use have limitations. In this study we show that LAN5 cells, a human neuroblastoma-derived cell line, are sensitive to BoNT/A and can be engineered to express a recombinant NanoLuciferase (NanoLuc)-tagged SNAP25 reporter molecule. On exposure, the reporter molecule is cleaved and releases a NanoLuc-SNAP25 fragment that can be captured on a 96-well plate for quantitative luminometry using a cleavage-specific SNAP25 antibody. We demonstrate, using purified BoNT/A and a commercial BoNT/A product, that the sensitivity of this new cell-based assay is in the fM range, comparable to that of the MBA. The new assay could replace the MBA in research and commercial testing of BoNT/A, benefiting both scientific progress and animal welfare.","PeriodicalId":51231,"journal":{"name":"Altex-Alternatives To Animal Experimentation","volume":" ","pages":"605-616"},"PeriodicalIF":4.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

No more monkey business: Advancing personalized medicine with animal-free research - Animalfree Research Forum 2023. 不再有猴子通过无动物研究推进个性化医疗 - 2023 年无动物研究论坛。

IF 5.6 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2311171

Miriam A Zemanova, Silvia Frey

引用次数: 0

Summer school for systematic reviews of animal studies: Fostering evidence-based and rigorous animal research. 动物研究系统综述暑期班：促进循证和严格的动物研究。

IF 5.6 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2310251

Marianna Rosso, Simona E Doneva, David W Howells, Cathalijn Hc Leenaars, Benjamin V Ineichen

引用次数: 0

Heads on! Designing a Qualification Framework for Organ-on-Chip. 迎头赶上！设计芯片上器官的资格认证框架。

IF 5.6 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 Epub Date: 2024-01-23 DOI: 10.14573/altex.2401231

Monica Piergiovanni, Milena Mennecozzi, Stavroula Sampani, Maurice Whelan

引用次数: 0

Role of standards and funding in accelerating the development and use of microphysiological systems. 标准和资金在加速开发和使用微观生理系统方面的作用。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2407061

Surat Parvatam, Harshita Mittal, Francesca Pistollato, Kasturi Mahadik, Lorna Ewart, Abhijit Majumder, Y K Gupta, Sonja Beken, Rajeshwari Adheseshan, Glyn Stacey, Vishal Gandhi, Dhiraj Kumar, Helder Constantino, Goutami Nayak, Tejaswini Ghurde, Mousumi Gupta, Alokparna Sengupta, Troy Seidle

引用次数: 0

Corrigendum to Incorporating new approach methodologies into regulatory nonclinical pharmaceutical safety assessment. 将新方法纳入监管性非临床药物安全性评估的更正。

IF 4.5 2区医学

Altex-Alternatives To Animal Experimentation Pub Date : 2024-01-01 DOI: 10.14573/altex.2408291

Jan Turner, Pandora Pound, Carla Owen, Isobel Hutchinson, Marina Hop, David Y S Chau, Lady V Barrios Silva, Mike Coleman, Audrey Dubourg, Lorna W Harries, Victoria Hutter, J Gerry Kenna, Volker M Lauschke, Winfried Neuhaus, Clive Roper, Paul B Watkins, Jonathan Welch, Laura Rego Avarez, Katy Taylor

引用次数: 0