Biologicals最新文献_第9页

Development of a droplet digital PCR for pertussis toxin locus copy number determination in a genetically-modified Bordetella pertussis strain 液滴数字聚合酶链式反应测定百日咳博德特菌百日咳毒素基因座拷贝数的研究

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101683

Raphaël Esson , Stéphanie Falque , Eric Abachin , Steve George , Nolwenn Nougarede

{"title":"Development of a droplet digital PCR for pertussis toxin locus copy number determination in a genetically-modified Bordetella pertussis strain","authors":"Raphaël Esson , Stéphanie Falque , Eric Abachin , Steve George , Nolwenn Nougarede","doi":"10.1016/j.biologicals.2023.101683","DOIUrl":"10.1016/j.biologicals.2023.101683","url":null,"abstract":"<div><p>To improve pertussis toxin (PT) yield in <em>B. pertussis</em> strains for vaccine production a genetically-engineered strain (gdPT 191-134 strain) with a second copy of the genetically detoxified PT (gdPT) locus was developed. The consistency of the production and genetic stability of the strain when used for vaccine production must be established. We developed two simplex ddPCR assays with PCR systems for <em>ptxA</em>, the target gene present in two copies, and <em>pgm</em>, the reference gene present as a single copy. The ddPCR assay had sufficient precision to discriminate the copy number of the PT locus accurately in two <em>B. pertussis</em> strains: one copy in the parent, non-genetically-engineered strain and two copies in the gdPT 191-134 strain. Using the ddPCR assays, we were able to show that the ratio of the <em>ptxA</em> to <em>pgm</em> genes decreased during serial culture passages, due to the loss of PT locus, which in turn, resulted in lower levels of PT production over time. We were then able to assess culture conditions that improved the stability of the double locus, as shown by non-significant reduction in gdPT toxin yield.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9654035","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

Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection 阿斯利康和国药集团疫苗作为加强剂预防新冠肺炎感染的比较。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101668

Arash Letafati , Nooshin Eyvazzadeh , Amirhossein Gharehkhani , Ayeh Khorshidian , Siavash Chalabiani , Elnaz Khodadoust Soufiani , Niloofar Khakpoor , Benyamin Shamsodini , Taranom Beheshti , Raha Taheri Bavili Olyaei , Anahita Soleimani , Fatemeh Melyani , Ghazal Mashhadi Hossein

{"title":"Comparison of AstraZeneca and sinopharm vaccines as boosters in protection against COVID-19 infection","authors":"Arash Letafati , Nooshin Eyvazzadeh , Amirhossein Gharehkhani , Ayeh Khorshidian , Siavash Chalabiani , Elnaz Khodadoust Soufiani , Niloofar Khakpoor , Benyamin Shamsodini , Taranom Beheshti , Raha Taheri Bavili Olyaei , Anahita Soleimani , Fatemeh Melyani , Ghazal Mashhadi Hossein","doi":"10.1016/j.biologicals.2023.101668","DOIUrl":"10.1016/j.biologicals.2023.101668","url":null,"abstract":"<div><h3>Background</h3><p>As the global number of confirmed cases rises past 640 million, vaccination remains the most effective measure in controlling COVID-19. Studies have shown that two doses of vaccination can significantly reduce hospitalization and mortality rates among patients, but the effectiveness of booster doses is also important. We aimed to evaluate the role played by the type of the 3rd dose of vaccination by comparing the safety and efficacy of two common vaccination histories differing only in the 3rd received dose.</p></div><div><h3>Methods</h3><p>We conducted a cross-sectional study on patients with respiratory symptoms suspected of having SARS-CoV-2 infection using Real-time PCR. We also collected information on the age, gender, and type of vaccine received for the third dose.</p></div><div><h3>Results</h3><p>Out of 346 cases with respiratory symptoms, 120 cases tested positive for SARS-CoV-2 and had received two doses of Sinopharm and a different booster dose of either AZD1222 (AstraZeneca) or BIBP (Sinopharm). Among these 120 patients, vaccination with AZD1222 as a booster dose resulted in fewer symptoms compared to those vaccinated with three doses of BIBP.</p></div><div><h3>Conclusions</h3><p>Our study demonstrates that booster doses can help reduce hospitalization and the severity of infection, and it appears that a combination of different vaccines may be effective against severe COVID-19 infection.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10008804/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9646627","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: 2

A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics 一种用于生物治疗中宿主细胞蛋白质表征的高灵敏度和强大的LC-MS平台

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101675

Qinqin Ji, Izabela Sokolowska, Rui Cao, Yulei Jiang, Jingjie Mo, Ping Hu

{"title":"A highly sensitive and robust LC-MS platform for host cell protein characterization in biotherapeutics","authors":"Qinqin Ji, Izabela Sokolowska, Rui Cao, Yulei Jiang, Jingjie Mo, Ping Hu","doi":"10.1016/j.biologicals.2023.101675","DOIUrl":"10.1016/j.biologicals.2023.101675","url":null,"abstract":"<div><p>Host cell proteins (HCPs) are a major class of process-related impurities that need to be closely monitored during the production of biotherapeutics. Mass spectrometry (MS) has emerged as a promising tool for HCP analysis due to its specificity for individual HCP's identification and quantitation. However, utilization of MS as a routine characterization tool is still limited due to the time-consuming procedures, non-standardized instrumentation and methodologies, and the limited sensitivity compared to the enzyme-linked immunosorbent assays (ELISA). In this study, we introduced a sensitive (limit of detection (LOD) at 1–2 ppm) and robust HCP profiling platform method with suitable precision and accuracy that can be readily adopted to antibodies and other biotherapeutic modalities without the need for HCP enrichment. The NIST mAb and multiple in-house antibodies were analyzed, and results were benchmarked with other reported studies. In addition, a targeted analysis method with optimized sample preparation for absolute quantitation of lipases was developed and qualified with an LOD of 0.6 ppm and precision of <15%, which can be further improved to an LOD of 5 ppb by using the nano-flow LC.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9649403","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

Aims and Scope/Editorial Board/Publishing Details 目标和范围/编辑委员会/出版细节

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/S1045-1056(23)00025-8

引用次数: 0

Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats 大鼠皮内注射装置对日本产沙宾衍生脊髓灰质炎灭活疫苗的剂量节约效果

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101677

Eriko Itoh , Sakiko Shimizu , Yasushi Ami , Yoichiro Iwase , Yuichi Someya

{"title":"Dose-sparing effect of Sabin-derived inactivated polio vaccine produced in Japan by intradermal injection device for rats","authors":"Eriko Itoh , Sakiko Shimizu , Yasushi Ami , Yoichiro Iwase , Yuichi Someya","doi":"10.1016/j.biologicals.2023.101677","DOIUrl":"10.1016/j.biologicals.2023.101677","url":null,"abstract":"<div><p>The live-attenuated oral polio vaccine has long been used as the standard for polio prevention, but in order to minimize the emergence of pathogenic revertants, the inactivated polio vaccine (IPV), which is administered intramuscularly or subcutaneously, is being increasingly demanded worldwide. However, there is a global shortage of IPV, and its cost is an obstacle in developing countries. Therefore, dose-sparing with intradermal administration of IPV has been investigated. In this study, rats were immunized by intradermal (ID) and intramuscular (IM) administration of Sabin-derived inactivated polio vaccine (sIPV) produced in Japan, and the immune responses were evaluated. The results showed that one-fifth (1/5)-dose of ID administration yielded neutralizing antibody titers comparable to the full-dose IM administration, whereas 1/5-dose of IM administration was less effective than the full dose. Furthermore, a vertical puncture-type ID injection device (Immucise) that was originally developed for humans was modified for rats, resulting in successful and stable ID administration into the thin skin of rats. Based on these results, the ID administration of sIPV using Immucise in clinical use is expected to offer benefits such as reduced amounts of vaccine per dose, cost-effectiveness, and thereby the feasibility of vaccination for more people.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9702879","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: 1

Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow 实验性囊性棘球蚴病是开发基于肽的疫苗的概念证明，遵循一种新的合理工作流程

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101684

Sebastian Miles , Sylvia Dematteis , Gustavo Mourglia-Ettlin

{"title":"Experimental cystic echinococcosis as a proof of concept for the development of peptide-based vaccines following a novel rational workflow","authors":"Sebastian Miles , Sylvia Dematteis , Gustavo Mourglia-Ettlin","doi":"10.1016/j.biologicals.2023.101684","DOIUrl":"10.1016/j.biologicals.2023.101684","url":null,"abstract":"<div><p>Vaccines are among the most important advances in medicine throughout the human history. However, conventional vaccines exhibit several drawbacks in terms of design and production costs. Peptide-based vaccines are attractive alternatives, since they can be designed mainly <span><em>in silico</em></span>, can be produced cheaply and safely, and are able to induce immune responses exclusively towards protective epitopes. Yet, a proper peptide design is needed, not only to generate peptide-specific immune responses, but also for them to recognize the native protein in the occurrence of a natural infection. Herein, we propose a rational workflow for developing peptide-based vaccines including novel steps that assure the cross-recognition of native proteins. In this regard, we increased the probability of generating efficient antibodies through the selection of linear B-cell epitopes free of post-translational modifications followed by analyzing the 3D-structure similarity between the peptide in-solution vs. within its parental native protein. As a proof of concept, this workflow was applied to a set of seven previously suggested potential protective antigens against the infection by <span><em>Echinococcus granulosus</em><em> sensu lato</em></span>. Finally, two peptides were obtained showing the capacity to induce specific antibodies able to exert anti-parasite activities in different <em>in vitro</em><span> settings, as well as to provide significant protection in the murine model of secondary echinococcosis.</span></p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9642803","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

Rapid production and free distribution of a synthetic RNA material to support SARS-CoV-2 molecular diagnostic testing 快速生产和免费分发合成RNA材料，以支持SARS-CoV-2分子诊断检测

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101680

Megan H. Cleveland, Erica L. Romsos, Carolyn R. Steffen, Nathan D. Olson, Stephanie L. Servetas, William G. Valiant, Peter M. Vallone

引用次数: 0

Klebsiella pneumoniae vaccine studies in animal models 肺炎克雷伯菌疫苗在动物模型中的研究

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101678

Parivash Ranjbarian , Zahra Sobhi Amjad , Roya Chegene Lorestani , Ali Shojaeian , Mosayeb Rostamian

{"title":"Klebsiella pneumoniae vaccine studies in animal models","authors":"Parivash Ranjbarian , Zahra Sobhi Amjad , Roya Chegene Lorestani , Ali Shojaeian , Mosayeb Rostamian","doi":"10.1016/j.biologicals.2023.101678","DOIUrl":"10.1016/j.biologicals.2023.101678","url":null,"abstract":"<div><p><span>The treatment of </span><span><em>Klebsiella pneumoniae</em></span> is faced with challenges demanding the development of a vaccination strategy. However, no approved and globally available vaccine exists yet. This study aimed to systematically review all published data on <em>K. pneumoniae</em><span><span> vaccines in animal models. Without time restrictions, electronic databases were searched using appropriate keywords. The retrieved studies were screened and the data of those that matched our inclusion criteria were collected and analyzed. In total, 2027 records were retrieved; of which 35 studies were included for </span>systematic review<span>. The most frequently used animal model was BALB/c mice. Proteins, polysaccharides<span><span>, and their combinations (conjugates) were the most common vaccine candidates used. The amount of antigen, the route used for immunization, and the challenge strategy was varying in the studies and were chosen based on several factors such as the animal model, the type of antigen, and the schedule of immunization. Almost all studies claimed that their vaccine was effective/protective, indicated by increasing survival rate, reducing organ bacterial load, and eliciting protective antibody and/or </span>cytokine responses. Altogether, the information presented here will assist researchers to have a better look at the </span></span></span><em>K. pneumoniae</em> vaccine candidates and to take more effective steps in the future.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9709398","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: 1

Collaborative study for the calibration of a replacement International Standard for Diphtheria Antitoxin Equine 校准替代品白喉抗毒素马国际标准的合作研究

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101682

Laura Hassall, Peter Rigsby, Paul Stickings

引用次数: 0

A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea 建立韩国乙肝免疫球蛋白第二项国家标准的合作研究

IF 1.7 4区生物学

Biologicals Pub Date : 2023-05-01 DOI: 10.1016/j.biologicals.2023.101679

Chan Woong Choi , Su Kyoung Seong , Ki Won Han , Hyun Jeong Kim , Kyung Hee Sohn , Sun Bo Shim , Yun Su Bang , JungHwan Cho , In Soo Shin

{"title":"A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea","authors":"Chan Woong Choi , Su Kyoung Seong , Ki Won Han , Hyun Jeong Kim , Kyung Hee Sohn , Sun Bo Shim , Yun Su Bang , JungHwan Cho , In Soo Shin","doi":"10.1016/j.biologicals.2023.101679","DOIUrl":"10.1016/j.biologicals.2023.101679","url":null,"abstract":"<div><p>This study aimed to establish a second national standard for hepatitis B immunoglobulin (HBIG) that can be used for potency assays of hepatitis B and normal immunoglobulin. The candidate material was manufactured using a process approved as Good Manufacturing Practice. The freeze-dried candidate preparation was tested for physicochemical and biological properties, including pH, residual moisture, molecular size distribution, and potency. A collaborative study was performed involving four laboratories, including the National Institute of Food and Drug Safety Evaluation, as an official national control laboratory in Korea and manufacturers. The potency was calibrated against the second international standard for HBIG using two enzyme immunoassays: enzyme-linked immunosorbent assay and electrochemiluminescence immunoassay. Results from 240 assays were obtained from four laboratories, and combined potency estimates were obtained by calculating the geometric means. Intra- and inter-laboratory variability showed acceptable geometric coefficients of variation of 1.3–6.0 and 3.2–3.6%, respectively. The candidate preparation showed satisfactory stability in accelerated thermal degradation and real-time stability tests. Based on these results, the potency value of 105 IU/vial was assigned (95% confidence intervals: 100.0–109.2 IU/vial), and it was deemed suitable to serve as the Korean national standard for HBIG.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10023320","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