Biologicals最新文献

{"title":"Circulation of yellow fever virus in Benin city, Edo state Nigeria","authors":"Joy Zitgwai Saidu ,&nbsp;Nosakhare Odeh Eghafona","doi":"10.1016/j.biologicals.2024.101765","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101765","url":null,"abstract":"<div><p>Yellow fever (YF) is one of the most acute viral hemorrhagic diseases of the 18th and 19th centuries, which continues to cause severe morbidity and mortality in Africa. After 21 years of no reported cases of yellow fever in Nigeria, till 2017 where a case was confirmed in Kwara State, also in November 2018,WHO was informed of a cluster of suspected yellow fever cases and deaths in Edo state, Nigeria. The study was among all age group attending health centres in Benin City, Edo state. A total of 280 blood samples were collected from consented febrile patients and were screened for antibodies to Zika virus using rapid diagnostic test (RDT) kits. Blood samples positive to Zika virus (IgM/IgG RDT), were subjected to molecular characterization. Using the <em>flavividae</em> family primers, six (6) samples where confirmed positive by Hemi-nested reverse transcription PCR (hnRT-PCR) sequencing. Nucleotide sequence blast revealed the sequenceswere similar to Yellow fever virus strains. Phylogenetic analysis revealed that the yellow fever virus sequences are closely related to the African strains. Despite the safe and effective yellow fever vaccine, yellow fever virus is seen to be in circulation, hence the need for continues mass vaccination.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101765"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140537206","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":"Comparison of skeletal muscle decellularization protocols and recellularization with adipose-derived stem cells for tissue engineering","authors":"Joyce Esposito ,&nbsp;Pricila da Silva Cunha ,&nbsp;Thaís Maria da Mata Martins ,&nbsp;Mariane Izabella Abreu de Melo ,&nbsp;Marcos Augusto de Sá ,&nbsp;Dawidson Assis Gomes ,&nbsp;Alfredo Miranda de Góes","doi":"10.1016/j.biologicals.2024.101767","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101767","url":null,"abstract":"<div><p>Decellularization is a novel technique employed for scaffold manufacturing, as a strategy for skeletal muscle (SM) tissue engineering applications. However, poor decellularization efficacy is still a problem for the use of decellularized scaffolds as truly biocompatible biomaterials. For recellularization, adipose-derived stem cells (ASCs) are a good option, due to their immunomodulatory and pro-regenerative capacity, but few studies have described their combination with muscle-decellularized matrices (mDMs). This work aimed to evaluate the efficiency of four multi-step decellularization protocols to produce mDMs and to investigate <em>in vitro</em> biocompatibility with ASCs. Here, we described the different efficacies of muscle decellularization methods, suggesting the need for stricter standardization of the method, considering the large range of applications in SM tissue engineering, which is also a promising platform for preclinical studies with rat disease models using autologous cells.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101767"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140823683","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":"An indirect ELISA for detecting anti-SARS-CoV-2 antibodies in human sera using a baculovirus-expressed recombinant nucleocapsid antigen","authors":"Matheus Bernardes Torres Fogaça ,&nbsp;Gildemar José Bezerra Crispim ,&nbsp;Djairo Pastor Saavedra ,&nbsp;Leonardo Lopes-Luz ,&nbsp;Leonardo Assis da Silva ,&nbsp;Brenda Rabello de Camargo ,&nbsp;Rafael Alves Guimarães ,&nbsp;Tatsuya Nagata ,&nbsp;Bergmann Morais Ribeiro ,&nbsp;Samira Bührer-Sékula","doi":"10.1016/j.biologicals.2024.101769","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101769","url":null,"abstract":"<div><p>This study focuses on the development and initial assessment of an indirect IgG enzyme-linked immunosorbent assay (ELISA) specifically designed to detect of anti-SARS-CoV-2 antibodies. The unique aspect of this ELISA method lies in its utilization of a recombinant nucleocapsid (N) antigen, produced through baculovirus expression in insect cells. Our analysis involved 292 RT-qPCR confirmed positive serum samples and 54 pre-pandemic healthy controls. The process encompassed cloning, expression, and purification of the SARS-CoV-2 N gene in insect cells, with the resulted purified protein employed in our ELISA tests. Statistical analysis yielded an Area Under the Curve of 0.979, and the optimized cut-off exhibited 92 % sensitivity and 94 % specificity. These results highlight the ELISA's potential for robust and reliable serological detection of SARS-CoV-2 antibodies. Further assessments, including a larger panel size, reproducibility tests, and application in diverse populations, could enhance its utility as a valuable biotechnological solution for diseases surveillance.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101769"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140949986","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":"Outer membrane vesicles as nanovaccine candidates against pathogenic Leptospira in experimental Guinea pig model","authors":"S. David ,&nbsp;Inbaraj Sophia ,&nbsp;Subbaiyan Anbazhagan ,&nbsp;M. Karikalan ,&nbsp;R. Saravanan ,&nbsp;K Nagaleekar Viswas ,&nbsp;Prasad Thomas ,&nbsp;Pallab Chaudhuri","doi":"10.1016/j.biologicals.2024.101764","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101764","url":null,"abstract":"<div><p><em>Leptospira interrogans</em> serovar Hardjo is a long slender bacterium of size 0.1–0.3 μm × 5–50 μm. It is one of the major causes of bovine leptospirosis and is of economical importance because of the reproductive failure, still birth, abortion, and reduced productivity in cattle. It is also a zoonotic disease-causing infection in humans characterized by headaches, fever, chills, sweats and myalgia, lethargy, aching joints, pulmonary haemorrhages, and death in severe cases. Control of the disease involves antibiotic therapy, management and vaccination, of which immunization is the cheapest and effective means of disease prevention. The present study was developed to isolate and characterize the outer membrane vesicles of Leptospira interrogans serovar Hardjo and to evaluate their vaccine potential in guinea pig model. The OMVs were isolated from the culture by sonication and ultracentrifugation. In transmission electron microscopy, the isolated OMVs appeared as small spherical structures of 50–200 nm size. In Western blot and indirect ELISA, antibodies specific to OMVs were observed as indicative of a good humoral immune response elicited by L. interrogans serovar Hardjo OMV. The OMV-based Leptospira vaccine was able to prevent kidney lesions and renal colonization compared to the control and bacterin vaccinated group as proven by histopathology and PCR.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101764"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140295842","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":"Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products","authors":"Takamasa Hirai ,&nbsp;Kiyoko Kataoka ,&nbsp;Yuzhe Yuan ,&nbsp;Keisuke Yusa ,&nbsp;Yoji Sato ,&nbsp;Kazuhisa Uchida ,&nbsp;Ken Kono","doi":"10.1016/j.biologicals.2023.101739","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101739","url":null,"abstract":"<div><p>Next-Generation Sequencing (NGS) can detect nucleic acid sequences in a massively parallel sequencing. This technology is expected to be widely applied for the detection of viral contamination in biologics. The recently published ICH-Q5A (R2) draft indicates that NGS could be an alternative or supplement to <em>in vitro</em> viral tests. To examine the performance of NGS for the <em>in vitro</em> detection of viruses, adenovirus type 5 (Ad5), a model virus, was inoculated into Vero cells, which are the most popular indicator cells for the detection of adventitious viruses in the <em>in vitro</em> test. Total RNA extracted from the Vero cells infected with Ad5 was serially diluted with that from non-infected Vero cells, and each sample was analyzed using short- or long-read NGSs. The limits of detection of both NGS methods were almost the same and both methods were sensitive enough to detect viral sequences as long as there was at least one copy in one assay. Although the multiplexing in NGS carries the risk of cross-contamination among the samples, which could lead to false positives, this technology has the potential to become a rapid and sensitive method for detecting adventitious agents in biologics.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"85 ","pages":"Article 101739"},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105623000787/pdfft?md5=c4d124133071af16d8b4d4c7ce4a847a&pid=1-s2.0-S1045105623000787-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138656257","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":"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":"85 ","pages":"Article 101746"},"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":"Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics","authors":"Loushambam Samananda Singh","doi":"10.1016/j.biologicals.2023.101725","DOIUrl":"10.1016/j.biologicals.2023.101725","url":null,"abstract":"<div><p>Antibiotic resistance has become the major concern for global public health. Phage therapy is being considered as an alternative for antibiotics to treat the multidrug resistant bacterial infections. Bacteriophage therapeutic developments has faced many challenges, including the drug formulations for sustainable phage delivery. The nano-emulsion platform has been described as the best approach to retain phage efficacy, shelf life and stability. Encapsulated phage drugs ensure stable delivery of phages to the target site and integrate in the system. In this review, our main focus is on the nano-emulsion encapsulation of bacteriophages and its effects towards the phage therapeutic development.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"85 ","pages":"Article 101725"},"PeriodicalIF":1.7,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89720652","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":"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":"85 ","pages":"Article 101747"},"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":"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":"85 ","pages":"Article 101748"},"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":"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":"85 ","pages":"Article 101751"},"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}