Biologicals最新文献

{"title":"Regulatory workshop on challenge strain development and GMP manufacture – A stakeholder meeting report","authors":"Nicoletta Corti ,&nbsp;Christopher Chiu ,&nbsp;Rebecca J. Cox ,&nbsp;Clarisse Demont ,&nbsp;Jeanne-Marie Devaster ,&nbsp;Othmar G. Engelhardt ,&nbsp;Andrew Gorringe ,&nbsp;Khaole Hassan ,&nbsp;Marcel Hoefnagel ,&nbsp;Ingrid Kamerling ,&nbsp;Oleg Krut ,&nbsp;Chelsea Lane ,&nbsp;Reinhard Liebers ,&nbsp;Catherine Luke ,&nbsp;Wim Van Molle ,&nbsp;Sandra Morel ,&nbsp;Pieter Neels ,&nbsp;Meta Roestenberg ,&nbsp;Michelle Rubbrecht ,&nbsp;Wiep Klaas Smits ,&nbsp;Ole F. Olesen","doi":"10.1016/j.biologicals.2024.101746","DOIUrl":"10.1016/j.biologicals.2024.101746","url":null,"abstract":"<div><p>Within the Innovative Health Initiative (IHI) Inno4Vac CHIMICHURRI project, a regulatory workshop was organised on the development and manufacture of challenge agent strains for Controlled Human Infection Model (CHIM) studies. Developers are often uncertain about which GMP requirements or regulatory guidelines apply but should be guided by the 2022 technical white paper “Considerations on the Principles of Development and Manufacturing Qualities of Challenge Agents for Use in Human Infection Models” (published by hVIVO, Wellcome Trust, HIC-Vac consortium members). Where those recommendations cannot be met, regulators advise following the “Principles of GMP” until definitive guidelines are available. Sourcing wild-type virus isolates is a significant challenge for developers. Still, it is preferred over reverse genetics challenge strains for several reasons, including implications and regulations around genetically modified organisms (GMOs). Official informed consent guidelines for collecting isolates are needed, and the characterisation of these isolates still presents risks and uncertainty. Workshop topics included ethics, liability, standardised clinical endpoints, selection criteria, sharing of challenge agents, and addressing population heterogeneity concerning vaccine response and clinical course. The organisers are confident that the workshop discussions will contribute to advancing ethical, safe, and high-quality CHIM studies of influenza, RSV and C. difficile, including adequate regulatory frameworks.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000034/pdfft?md5=f4e2d31e18dcf2f7b337d033b78790fe&pid=1-s2.0-S1045105624000034-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139677900","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}

{"title":"Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023","authors":"Marco Cavaleri ,&nbsp;David Kaslow ,&nbsp;Eric Boateng ,&nbsp;Wilbur H. Chen ,&nbsp;Christopher Chiu ,&nbsp;Robert K.M. Choy ,&nbsp;Rodrigo Correa-Oliveira ,&nbsp;Anna Durbin ,&nbsp;Moses Egesa ,&nbsp;Malick Gibani ,&nbsp;Melissa Kapulu ,&nbsp;Melba Katindi ,&nbsp;Ally Olotu ,&nbsp;Pongphaya Pongsuwan ,&nbsp;Michelo Simuyandi ,&nbsp;Bruno Speder ,&nbsp;Kawsar R. Talaat ,&nbsp;Charlie Weller ,&nbsp;Bridget Wills ,&nbsp;Marc Baay ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2024.101745","DOIUrl":"10.1016/j.biologicals.2024.101745","url":null,"abstract":"<div><p>Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000022/pdfft?md5=4b7ceed9d1cf2f1134b90121cff6902a&pid=1-s2.0-S1045105624000022-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139716588","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}

{"title":"Ethical approval for controlled human infectious model clinical trial protocols – A workshop report","authors":"Euzebiusz Jamrozik ,&nbsp;Katherine Littler ,&nbsp;Irina Meln ,&nbsp;Wim Van Molle ,&nbsp;Sandra Morel ,&nbsp;Ole F. Olesen ,&nbsp;Michelle Rubbrecht ,&nbsp;Shobana Balasingam ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2024.101748","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101748","url":null,"abstract":"<div><p>Controlled Human Infectious Model studies (CHIM) involve deliberately exposing volunteers to pathogens. To discuss ethical issues related to CHIM, the European Vaccine Initiative and the International Alliance for Biological Standardization organised the workshop “Ethical Approval for CHIM Clinical Trial Protocols”, which took place on May 30–31, 2023, in Brussels, Belgium. The event allowed CHIM researchers, regulators, ethics committee (EC) members, and ethicists to examine the ethical criteria for CHIM and the role(s) of CHIM in pharmaceutical development. The discussions led to several recommendations, including continued assurance that routine ethical requirements are met, assurance that participants are well-informed, and that preparation of study documents must be both ethically and scientifically sound from an early stage. Study applications must clearly state the rationale for the challenge compared to alternative study designs. ECs need to have clear guidance and procedures for evaluating social value and assessing third-party risks. Among other things, public trust in research requires minimisation of harm to healthy volunteers and third-party risk. Other important considerations include appropriate stakeholder engagement, public education, and access to health care for participants after the study.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000058/pdfft?md5=702bf2c7df5627ff20877624237348e6&pid=1-s2.0-S1045105624000058-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139718607","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}

{"title":"Fourth Controlled Human Infection Model (CHIM) meeting – CHIMs in endemic countries, May 22–23, 2023","authors":"Melissa Kapulu ,&nbsp;Lucinda Manda-Taylor ,&nbsp;Shobana Balasingam ,&nbsp;Gary Means ,&nbsp;Mikal Ayiro Malungu ,&nbsp;Philip Bejon ,&nbsp;Primus Che Chi ,&nbsp;Christopher Chiu ,&nbsp;E. Chandler Church ,&nbsp;Rodrigo Correa-Oliveira ,&nbsp;Nicholas Day ,&nbsp;Anna Durbin ,&nbsp;Moses Egesa ,&nbsp;Claudia Emerson ,&nbsp;Kondwani Jambo ,&nbsp;Roli Mathur ,&nbsp;Wolfram Metzger ,&nbsp;Noni Mumba ,&nbsp;Winfred Nazziwa ,&nbsp;Ally Olotu ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2024.101747","DOIUrl":"10.1016/j.biologicals.2024.101747","url":null,"abstract":"<div><p>Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000046/pdfft?md5=440fe4e1d3cece54f9e77639d77e127c&pid=1-s2.0-S1045105624000046-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139731094","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}

{"title":"Viral clearance capability of monoclonal antibody purification","authors":"Kang Cai,&nbsp;Jennifer Anderson,&nbsp;Etienne Utiger,&nbsp;Gisela Ferreira","doi":"10.1016/j.biologicals.2024.101751","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101751","url":null,"abstract":"<div><p>Viral clearance steps are routinely included in monoclonal antibody purification processes to safeguard product from potential virus contamination. These steps are often experimentally studied using product-specific feeds and parameters for each project to demonstrate viral clearance capability. However, published evidence suggests that viral clearance capability of many of these steps are not significantly impacted by variations in feed material or process parameter within commonly used ranges. The current investigation confirms robust retrovirus inactivation by low pH treatment and parvovirus removal by second-generation virus filters, independent to individual antibody molecules. Our results also reveal robust retrovirus removal by flowthrough anion exchange chromatography, inside the limits of protein load and host cell protein content. The cumulative viral clearance capability from these steps leads to an excess clearance safety factor of 10,000-fold for endogenous retrovirus-like particles. These results further justify the use of prior knowledge-based modular viral clearance estimation as opposed to repetitive experimentation.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000083/pdfft?md5=d0b3e6fb4801ccbf24c8f049e831b8d6&pid=1-s2.0-S1045105624000083-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139914499","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}

{"title":"The role of real-world evidence for regulatory and public health decision-making for Accelerated Vaccine Deployment- a meeting report","authors":"Kaatje Bollaerts ,&nbsp;Chloé Wyndham-Thomas ,&nbsp;Elizabeth Miller ,&nbsp;Hector S. Izurieta ,&nbsp;Steve Black ,&nbsp;Nick Andrews ,&nbsp;Michelle Rubbrecht ,&nbsp;Fran Van Heuverswyn ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2024.101750","DOIUrl":"10.1016/j.biologicals.2024.101750","url":null,"abstract":"<div><p>The COVID-19 pandemic underscored the need for rapid evidence generation to inform public health decisions beyond the limitations of conventional clinical trials. This report summarises presentations and discussions from a conference on the role of Real-World Evidence (RWE) in expediting vaccine deployment. Attended by regulatory bodies, public health entities, and industry experts, the gathering was a collaborative exchange of experiences and recommendations for leveraging RWE for vaccine deployment.</p><p>RWE proved instrumental in refining decision-making processes to optimise dosing regimens, enhance guidance on target populations, and steer vaccination strategies against emerging variants. Participants felt that RWE was successfully integrated into lifecycle management, encompassing boosters and safety considerations. However, challenges emerged, prompting a call for improvements in data quality, standardisation, and availability, acknowledging the variability and potential inaccuracies in data across diverse healthcare systems. Regulatory transparency should also be prioritised to foster public trust, and improved collaborations with governments are needed to streamline data collection and navigate data privacy regulations. Moreover, building and sustaining resources, expertise, and infrastructure in LMICs emerged as imperative for RWE-generating capabilities. Continued stakeholder collaboration and securing adequate funding emerged as vital pillars for advancing the use of RWE in shaping responsive and effective public health strategies.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000071/pdfft?md5=ed088f7232572558fa7073100a8fd06b&pid=1-s2.0-S1045105624000071-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139742779","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}

{"title":"A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency","authors":"Reihaneh Mirhassani ,&nbsp;Ehsan Seyedjafari ,&nbsp;Behrouz Vaziri","doi":"10.1016/j.biologicals.2023.101742","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101742","url":null,"abstract":"<div><p>Vaccine potency is typically evaluated using an assay that acts as a surrogate for biological activity. Although in vivo vaccines better represent human immunological responses, in vitro assays are preferred due to lower variability, higher throughput, easier validation and ethical considerations. In in vitro determination of Human Papillomavirus (HPV), Virus-like particle (VLP) vaccine potency currently depends on monoclonal antibody assays. However, these reagents are hard to obtain and currently are not available commercially. In this work, a polyclonal antiserum-based immunoassay was developed to evaluate the relative potency of Alhydrogel formulated HPV 16 VLPs. The repeatability and specificity were evaluated, and found that the assay was sensitive to small amounts of non-VLP HPV 16 L1 proteins. Finally, the assay was tested in comparison to the mouse effective dose 50 (ED50) assay on a limited number of batches. The agreement between these results suggests this test as a suitable surrogate for the in vivo test.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139714276","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}

{"title":"Aims and Scope/Editorial Board/Publishing Details","authors":"","doi":"10.1016/S1045-1056(24)00017-4","DOIUrl":"https://doi.org/10.1016/S1045-1056(24)00017-4","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000174/pdfft?md5=cdcba3a86f575524dbe35f84fdec704c&pid=1-s2.0-S1045105624000174-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140195586","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}

{"title":"Development of an ELISA for the detection of fowl adenovirus serotype −4 utilizing fiber protein","authors":"Faiza Ather ,&nbsp;Muhammad Ashir Zia ,&nbsp;Mudasser Habib ,&nbsp;Muhammad Salah-ud-din Shah","doi":"10.1016/j.biologicals.2024.101752","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101752","url":null,"abstract":"<div><p>Hydropericardium syndrome (HPS), caused by the Fowl adenovirus 4 (FAdV-4) has led to significant financial losses for the poultry industry globally, including Pakistan over the past few years. Conventional serological methods are time consuming, laborious and less sensitive therefore, a rapid and sensitive ELISA kit is required for the reliable detection of FAdV-4 infection. In the current research, fiber proteins (1 &amp;2) of FAdV-4 were successfully expressed in <em>Escherichia coli</em> and purified using metal affinity chromatography. Using these proteins as antigens, an indirect ELISA for detecting FAdV-4 infection was developed. The developed ELISA showed superior performances upon comparison with Serum neutralization test (SNT). This ELISA also showed reliable detection of FAdV specific antibodies in experimentally infected and vaccinated chickens. This assay produced good correlation on the samples collected from the field with SNT and found essential for large scale serology of the FAdV. No cross reactivity was observed in the ELISA following the testing of the serum samples of different other avian pathogens which showed that this ELISA is specific in detecting the FAdV infection. In conclusion, the developed Fiber protein ELISA is highly sensitive and specific in the detecting the FAdV infection and can be utilized for large scale sero-epidemiology of the disease.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139936391","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}

{"title":"Report for the Eighth Asian National Control Laboratory Network meeting in 2023: Self-sufficiency strategy of plasma-derived medicinal products and regulatory harmonisation","authors":"Chan Woong Choi ,&nbsp;Youngju Choi ,&nbsp;Yuyun Siti Maryuningsih ,&nbsp;Bayu Wibisono ,&nbsp;Jong Won Kim ,&nbsp;Dio Ramondrana ,&nbsp;Takuo Mizukami ,&nbsp;Masaki Ochiai ,&nbsp;Azraini Abdul Samat ,&nbsp;Caren Mangorangca ,&nbsp;Dung Luu Thi ,&nbsp;Hung Pham Van ,&nbsp;Sun Bo Shim ,&nbsp;Su Kyoung Seong ,&nbsp;In Soo Shin","doi":"10.1016/j.biologicals.2024.101754","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101754","url":null,"abstract":"<div><p>The Eighth Asian National Control Laboratory (NCL) Network meeting, entitled “Biological Products Quality Control and Self-Sufficiency Strategy focusing on plasma-derived medicinal products (PDMPs)” was held in Seoul on 31 August 2023. The participants were NCL experts from Indonesia, Japan, Malaysia, the Philippines, Vietnam, and the Republic of Korea. Special lectures included the PDMPs self-sufficiency strategies of the World Health Organization (WHO) and Indonesian Food and Drug Authority, and a case study on Global Benchmarking Tool (GBT) assessment for vaccines by the Korea Ministry of Food and Drug Safety. The NCL delegates shared their current experiences with national lot releases and biological standardisation. The meeting contributed to a mutual understanding of the progress of the PDMPs self-sufficiency among Asian countries, the WHO's support strategies, and the NCL's plan for the preparation of the WHO GBT assessment. In the panel discussion, all participants agreed that building capacity in blood safety in the Asian region and harmonisation of relevant international regulatory requirements will support appropriate emergency preparedness, particularly source materials in the region, and will build the foundation for resolving the PDMPs supply insecurity that has worsened after the COVID-19 pandemic in some countries.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000113/pdfft?md5=9059f829a81fccde4e33579314f90f79&pid=1-s2.0-S1045105624000113-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999320","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}