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Molecular characterization of Anaplasma ovis Msp4 protein in strains isolated from ticks in Turkey: A multi-epitope synthetic vaccine antigen design against Anaplasma ovis using immunoinformatic tools 从土耳其蜱虫中分离出的弓形虫 Msp4 蛋白的分子特征：利用免疫形式化工具设计多表位合成疫苗抗原以预防猫疟原虫感染

IF 1.7 4区生物学

Biologicals Pub Date : 2024-02-01 DOI: 10.1016/j.biologicals.2024.101749

Ahmet Efe Köseoğlu , Hüseyin Can , Mervenur Güvendi , Sedef Erkunt Alak , Aysu Değirmenci Döşkaya , Muhammet Karakavuk , Mert Döşkaya , Cemal Ün

{"title":"Molecular characterization of Anaplasma ovis Msp4 protein in strains isolated from ticks in Turkey: A multi-epitope synthetic vaccine antigen design against Anaplasma ovis using immunoinformatic tools","authors":"Ahmet Efe Köseoğlu , Hüseyin Can , Mervenur Güvendi , Sedef Erkunt Alak , Aysu Değirmenci Döşkaya , Muhammet Karakavuk , Mert Döşkaya , Cemal Ün","doi":"10.1016/j.biologicals.2024.101749","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101749","url":null,"abstract":"<div>Tick-borne pathogens increasingly threaten animal and human health as well as cause great economic loss in the livestock industry. Among these pathogens, Anaplasma ovis causing a decrease in meat and milk yield is frequently detected in sheep in many countries including Turkey. This study aimed to reveal potential vaccine candidate epitopes in Msp4 protein using sequence data from Anaplasma ovis isolates and then to design a multi-epitope protein to be used in vaccine formulations against Anaplasma ovis. For this purpose, Msp4 gene was sequenced from Anaplasma ovis isolates (n:6) detected in ticks collected from sheep in Turkey and the sequence data was compared with previous sequences from different countries in order to detect the variations of Msp4 gene/protein. Potential vaccine candidate and diagnostic epitopes were predicted using various immunoinformatics tools. Among the discovered vaccine candidate epitopes, antigenic and conserved were selected, and then a multi-epitope protein was designed. The designed vaccine protein was tested for the assessment of TLR-2, IgG, and IFN-g responses by molecular docking and immune simulation analyses. Among the discovered epitopes, EVASEGSGVM and YQFTPEISLV epitopes with properties of high antigenicity, non-allergenicity, and non-toxicity were proposed to be used for Anaplasma ovis in further serodiagnostic and vaccine studies.</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":"139694762","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

The current status of the biosimilars landscape in China 中国生物仿制药的现状

IF 1.7 4区生物学

Biologicals Pub Date : 2024-02-01 DOI: 10.1016/j.biologicals.2024.101744

Gangling Xu, Junzhi Wang

引用次数: 0

Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology 通过反向疫苗学鉴定百日咳博德特氏菌新型候选疫苗

IF 1.7 4区生物学

Biologicals Pub Date : 2024-01-12 DOI: 10.1016/j.biologicals.2023.101740

Gloria Paulina Monterrubio-López, José Luis Llamas-Monroy, Ángel Antonio Martínez-Gómez, Karen Delgadillo-Gutiérrez

{"title":"Novel vaccine candidates of Bordetella pertussis identified by reverse vaccinology","authors":"Gloria Paulina Monterrubio-López, José Luis Llamas-Monroy, Ángel Antonio Martínez-Gómez, Karen Delgadillo-Gutiérrez","doi":"10.1016/j.biologicals.2023.101740","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101740","url":null,"abstract":"<div>Whooping cough is a disease caused by Bordetella pertussis, whose morbidity has increased, motivating the improvement of current vaccines. Reverse vaccinology is a strategy that helps identify proteins with good characteristics fast and with fewer resources. In this work, we applied reverse vaccinology to study the B. pertussis proteome and pangenome with several in-silico tools. We analyzed the B. pertussis Tohama I proteome with NERVE software and compared 234 proteins with B. parapertussis, B. bronchiseptica, and B. holmessi. VaxiJen was used to calculate an antigenicity value; our threshold was 0.6, selecting 84 proteins. The candidates were depurated and grouped in eight family proteins to select representative candidates, according to bibliographic information and their immunological response predicted with ABCpred, Bcepred, IgPred, and C-ImmSim. Additionally, a pangenome study was conducted with 603 B. pertussis strains and PanRV software, identifying 3421 core proteins that were analyzed to select the best candidates. Finally, we selected 15 proteins from the proteome study and seven proteins from the pangenome analysis as good vaccine candidates.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139434331","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

Efficient extraction of adventitious virus nucleic acid using commercially available methods 使用市售方法高效提取不定病毒核酸

IF 1.7 4区生物学

Biologicals Pub Date : 2023-12-28 DOI: 10.1016/j.biologicals.2023.101741

William G. Valiant , Jon Borman , Kang Cai , Peter M. Vallone

{"title":"Efficient extraction of adventitious virus nucleic acid using commercially available methods","authors":"William G. Valiant , Jon Borman , Kang Cai , Peter M. Vallone","doi":"10.1016/j.biologicals.2023.101741","DOIUrl":"10.1016/j.biologicals.2023.101741","url":null,"abstract":"<div>An essential step in pharmaceutical product development is screening for contamination with adventitious agents, and there is desire to develop highly sensitive assays to detect adventitious viral nucleic acid. This study sought to examine the nucleic acid extraction efficiency of three viral candidates in relevant background matrices using four different extraction methods. Three model adventitious viruses, Minute virus of Mice, Porcine Circovirus, and Feline Leukemia Virus, were diluted within a variety of background matrices relevant to pharmaceutical production methods. Upon extraction, the nucleic acid was quantified using droplet digital PCR methods. Four nucleic acid extraction methods were assessed, including commercially available kits and manual extraction methods. Each method recovered nucleic acid post-extraction for each of the model viruses within the tested background matrices. The silica-column based method recovered a greater amount of viral nucleic acid, compared to the other methods tested. Similar trends were observed when model virus was diluted in bioreactor supernatant, which replicates industry testing conditions and provides details on which extraction methods might be used in Next Generation Sequencing and PCR methods for detecting contamination within pharmaceutical products.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105623000805/pdfft?md5=39acf426ad0ebeda5e79d918351d89c7&pid=1-s2.0-S1045105623000805-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139068246","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 next-generation sequencing performance for in vitro detection of viruses in biological products 评估新一代测序技术在体外检测生物制品中病毒方面的性能

IF 1.7 4区生物学

Biologicals Pub Date : 2023-12-15 DOI: 10.1016/j.biologicals.2023.101739

Takamasa Hirai , Kiyoko Kataoka , Yuzhe Yuan , Keisuke Yusa , Yoji Sato , Kazuhisa Uchida , Ken Kono

{"title":"Evaluation of next-generation sequencing performance for in vitro detection of viruses in biological products","authors":"Takamasa Hirai , Kiyoko Kataoka , Yuzhe Yuan , Keisuke Yusa , Yoji Sato , Kazuhisa Uchida , Ken Kono","doi":"10.1016/j.biologicals.2023.101739","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101739","url":null,"abstract":"<div>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 in vitro viral tests. To examine the performance of NGS for the in vitro 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 in vitro 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.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-12-15","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}

引用次数: 0

An antibody-free evaluation of an mRNA COVID-19 vaccine 对 mRNA COVID-19 疫苗进行无抗体评估

IF 1.7 4区生物学

Biologicals Pub Date : 2023-12-14 DOI: 10.1016/j.biologicals.2023.101738

Paul J. Branham , Hans C. Cooper , Yulanda M. Williamson , Fabio N. Najjar , William J.H. Sutton , Carrie L. Pierce-Ruiz , John R. Barr , Tracie L. Williams

{"title":"An antibody-free evaluation of an mRNA COVID-19 vaccine","authors":"Paul J. Branham , Hans C. Cooper , Yulanda M. Williamson , Fabio N. Najjar , William J.H. Sutton , Carrie L. Pierce-Ruiz , John R. Barr , Tracie L. Williams","doi":"10.1016/j.biologicals.2023.101738","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101738","url":null,"abstract":"<div>This manuscript describes the use of an analytical assay that combines transfection of mammalian cells and isotope dilution mass spectrometry (IDMS) for accurate quantification of antigen expression. Expired mRNA COVID-19 vaccine material was stored at 4 °C, room temperature (∼25 °C), and 56 °C over a period of 5 weeks. The same vaccine was also exposed to 5 freeze-thaw cycles. Every week, the spike protein antigenic expression in mammalian (BHK-21) cells was evaluated. Housekeeping proteins, β-actin and GAPDH, were simultaneously quantified to account for the variation in cell counts that occurs during maintenance and growth of cell cultures. Data show that vaccine stored at elevated temperatures results in reduced spike protein expression. Also, maintaining the vaccine in ultracold conditions or exposing the vaccine to freeze-thaw cycles had less effect on the vaccine's ability to produce the antigen in mammalian cells. We describe the use of IDMS as an antibody-free means to accurately quantify expressed protein from mammalian cells transfected with mRNA vaccine.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138656771","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

Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice 新型水/油乳剂配方对小鼠传染性支气管炎 (IB) 疫苗免疫反应的佐剂效应

IF 1.7 4区生物学

Biologicals Pub Date : 2023-12-14 DOI: 10.1016/j.biologicals.2023.101736

Karrar Ali Mohammed Hasan Alsakini , Furkan Ozan Çöven , Ayse Nalbantsoy

{"title":"Adjuvant effects of novel water/oil emulsion formulations on immune responses against infectious bronchitis (IB) vaccine in mice","authors":"Karrar Ali Mohammed Hasan Alsakini , Furkan Ozan Çöven , Ayse Nalbantsoy","doi":"10.1016/j.biologicals.2023.101736","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101736","url":null,"abstract":"<div>Vaccines have long made use of adjuvants to boost the immune response of the body and reduce the amount of vaccine needed as well as the expense of producing the vaccine. Many vaccine adjuvants are in development, but their application in veterinary vaccinations is restricted due to their lack of efficacy or undesirable side effects. For this reason, it is essential to develop novel adjuvants. To address the issue that the currently available infectious bronchitis (IB) vaccine often fails to produce sufficient immune responses, Coral Biotechnology tested two of their newly developed water-in-oil (W/O) type emulsion adjuvants (Coralvac RZ 528 and Coralvac RZ 506) in the IB vaccine. These adjuvants were tested in a mouse model to determine whether it worked with an inactive IBV H120 vaccine. Vaccine formulations were prepared by combining a virus concentration of 1 × 106 EID50/0.1 ml with an emulsion of the W/O type in a specific ratio. Once the formulations were ready, it was injected intramuscularly as a single dosage, and the mice were monitored for 21 days afterwards. The results showed that anti-IB antibody titer (IgG and IgG1), CD3+ CD8+ T cell responses as well as IFN- γ cytokine production, and splenocyte proliferation were all considerably higher in the IBV H120 with Coralvac RZ 528 and IBV H120 with Coralvac RZ 506 formulation groups than in the viral control group. According to our findings, the humoral and cellular immune responses of mice were significantly enhanced by these novel vaccine adjuvants. Thus, our results provide evidence that the W/O type emulsion adjuvants developed by Coral Biotechnology may be a useful adjuvant in IBV vaccines.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138656258","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

Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis 开发狗用纳米疫苗预防囊性棘球蚴病的纳米颗粒配方

IF 1.7 4区生物学

Biologicals Pub Date : 2023-12-14 DOI: 10.1016/j.biologicals.2023.101737

Cecilia Silvarrey, Gabriela Alvite, Adriana Esteves

{"title":"Nanoparticle formulation for the development of a dog nanovaccine against Cystic Echinococcosis","authors":"Cecilia Silvarrey, Gabriela Alvite, Adriana Esteves","doi":"10.1016/j.biologicals.2023.101737","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101737","url":null,"abstract":"<div>Cystic Echinococcosis is a cosmopolitan zoonosis closely linked to poverty and ignorance. It affects both cattle and humans, causing significant losses to both human and animal health. To date, there is no effective way to combat this. Our proposal focused on the formulation of poly (lactic-co-glycolic acid (PLGA) and Eudragit-RSPO polymeric nanoparticles, which are suitable to encapsulate an antigen for oral administration in dogs. This antigen, named EgFABP1, belonging to the family of fatty acid-binding proteins, was isolated from the larval form of the parasite Echinococcus granulosus. Several reports point to proteins from this family from parasitic flatworms as candidates for a successful vaccine, considering the restricted lipid metabolism of these organisms. The encapsulation of the antigen yielded an efficiency higher than 50 %, and the nanoparticles showed the expected size range. In addition, antigen integrity was conserved and the formulation was resistant to artificial gastric and intestinal fluid effects.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138656259","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

Fifty years of advancing biologicals and beyond 五十年来不断发展生物制品。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-21 DOI: 10.1016/j.biologicals.2023.101727

Rajesh Gupta, Griffiths Elwyn, Girish Vyas, Robin Thorpe, Norman Baylor

引用次数: 0

Enabling the evaluation of COVID-19 vaccines with correlates of protection 能够评估具有相关保护作用的COVID-19疫苗

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-16 DOI: 10.1016/j.biologicals.2023.101723

Arnaud Marchant , Pierre Van Damme , Stanley Plotkin , Pieter Neels , Maria Cristina Cassetti , Jakob Cramer , Marion F. Gruber , David Goldblatt , Deborah King , Wendy Hartig-Merkel , Joris Vandeputte

{"title":"Enabling the evaluation of COVID-19 vaccines with correlates of protection","authors":"Arnaud Marchant , Pierre Van Damme , Stanley Plotkin , Pieter Neels , Maria Cristina Cassetti , Jakob Cramer , Marion F. Gruber , David Goldblatt , Deborah King , Wendy Hartig-Merkel , Joris Vandeputte","doi":"10.1016/j.biologicals.2023.101723","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101723","url":null,"abstract":"<div>In February 2023, a meeting about correlates of protection (CoPs) against COVID-19 was organized by the International Alliance for Biological Standardization, the European Plotkin Institute for Vaccinology, and Vaccinopolis. The meeting aimed at reviewing the evidence, drawing conclusions, and identifying knowledge gaps.Collection of evidence is not straightforward. Neutralizing antibodies correlate with protection and are used for immunobridging studies within and between vaccine platforms for approval of new COVID-19 vaccines. In preparation for the next pandemic, it is vital that rapidly authorized initial vaccines are available to perform immunobridging studies very early. Additional components of the immune response likely contribute to protection against symptomatic infection. Current evidence is strongest for T lymphocytes and binding antibodies. Further studies are needed to consolidate this evidence and define their potential role in the evaluation of vaccines. For evaluation of mucosal vaccines, identifying CoPs against infection and transmission is key; further research is needed to identify and standardize methods suitable for clinical studies. CoPs for broadly protective beta-coronavirus vaccines remain a critical area of research.The knowledge, expertise, and capacity exist to conduct clinical studies using different designs in different populations to discover and validate CoPs, facilitating and accelerating evaluation of novel vaccines/vaccination platforms.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105623000623/pdfft?md5=efc43d5e6a2a37ccfb744563611c22f2&pid=1-s2.0-S1045105623000623-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134843724","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