Biologicals最新文献_第6页

Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections 用大肠杆菌表达纯化乙型肝炎病毒核心抗原及其在乙型肝炎病毒感染诊断中的应用

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-16 DOI: 10.1016/j.biologicals.2023.101726

Mohammed El-Mowafy , Mohamed El-Mesery , Mahmoud A.F. Khalil , Ahmed El-Mesery , Abdelaziz Elgaml

{"title":"Expression and purification of Hepatitis B virus core antigen using Escherichia coli and its utilization for the diagnosis of Hepatitis B virus infections","authors":"Mohammed El-Mowafy , Mohamed El-Mesery , Mahmoud A.F. Khalil , Ahmed El-Mesery , Abdelaziz Elgaml","doi":"10.1016/j.biologicals.2023.101726","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101726","url":null,"abstract":"<div>Hepatitis B virus (HBV) is responsible for most of the viral hepatitis worldwide. HBV is a partially double stranded DNA virus that is composed of four main open reading frames (ORFs) encoding its important antigens, namely hepatitis B surface antigen (HBsAg), hepatitis B core antigen (HBcAg), HBV polymerase and hepatitis B X antigen (HBxAg). In this study, we report a successful method for the cloning and expression of HBcAg. The ORF of HBcAg was successfully amplified using polymerase chain reaction (PCR), cloned into the expression vector pRSET-B and transformed to Escherichia coli (E. coli) BL-21 (DE3) pLysS strain for protein expression. Successful expression of HBcAg was accomplished, in which an induced protein with a molecular weight of 24 kDa was obtained and confirmed by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and Western blotting. The produced HBcAg was successfully used for the diagnosis of HBV infected patient through detection of antibodies against HBcAg (anti-HBcAg) in the serum of the patient utilizing Western blotting. Overall, this study provides a simple, convenient and efficient protocol for the production of HBcAg that can be used as an important candidate to study the diagnosis and prognosis of HBV disease, as well as for understanding the epidemiological prevalence of HBV cases and production of anti-HBcAg.</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":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134843726","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

A rapid and simple sterility test method based on solid culture medium containing blood 一种基于含血固体培养基的快速简便无菌检验方法

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-11 DOI: 10.1016/j.biologicals.2023.101722

Neetu Raghav , Seema Parveen , Simleen Kaur , Selwyn A. Wilson David, Hyesuk Kong, James L. Kenney, Rajesh K. Gupta

{"title":"A rapid and simple sterility test method based on solid culture medium containing blood","authors":"Neetu Raghav , Seema Parveen , Simleen Kaur , Selwyn A. Wilson David, Hyesuk Kong, James L. Kenney, Rajesh K. Gupta","doi":"10.1016/j.biologicals.2023.101722","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101722","url":null,"abstract":"<div>Current sterility test performed for most biological products takes 14 days. We evaluated solid medium, containing 5% blood for use in the membrane filtration (MF) and direct inoculation (DI) sterility test. Representative microorganisms prepared in a sample matrix at approximately 0.1, 1, 10 and 100 colony forming units were tested for growth by compendial MF sterility test using fluid thioglycolate medium and tryptic soy broth and also on the Schaedler blood agar (SBA). Sterility test performed on SBA was significantly more sensitive and faster in detecting various microorganisms than the compendial method, particularly for sample matrix containing 0.01% thimerosal (p < 0.05). SBA detected all microorganisms within 7 days. To implement solid medium in the DI sterility test, multiple BA plates were inoculated with the sample. All representative microorganisms were detected within 5 days. The sterility test using solid medium required 3 different incubation conditions, 30–35 °C aerobically and anaerobically to detect bacteria, and at 20–25 °C aerobically to detect mold and yeast. To eliminate aerobic incubation of solid medium at 20–25 °C, we evaluated representative species of mold and yeast for their growth at 30–35 °C and 20–25 °C in the sterility test performed on solid medium. Penicillium chrysogenum could not be detected at 30–35 °C consistently within 7 days. Sterility test performed on solid medium without any additional technology could be completed in 7 days, as compared to the 14 days required for the current compendial method.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"92060835","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

Nano-emulsion encapsulation for the efficient delivery of bacteriophage therapeutics 用于噬菌体治疗药物有效递送的纳米乳液封装。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-09 DOI: 10.1016/j.biologicals.2023.101725

Loushambam Samananda Singh

引用次数: 0

Evaluating the sensitivity of newborn rats and newborn hamsters to oncogenic DNA 评估新生大鼠和新生仓鼠对致癌DNA的敏感性

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-01 DOI: 10.1016/j.biologicals.2023.101724

Li Sheng-Fowler , Wei Tu , Kathryn Phy , Juliete Macauley , Lynda Lanning , Andrew M. Lewis Jr. , Keith Peden

{"title":"Evaluating the sensitivity of newborn rats and newborn hamsters to oncogenic DNA","authors":"Li Sheng-Fowler , Wei Tu , Kathryn Phy , Juliete Macauley , Lynda Lanning , Andrew M. Lewis Jr. , Keith Peden","doi":"10.1016/j.biologicals.2023.101724","DOIUrl":"https://doi.org/10.1016/j.biologicals.2023.101724","url":null,"abstract":"<div>To evaluate the risk of residual cellular DNA in vaccines manufactured in tumorigenic cell lines, we have been establishing in vivo assays to quantify the oncogenic activity of DNA. We had generated three oncogene-expression plasmids: pMSV-T24-H-ras, which expresses activated H-ras; pMSV-c-myc, which expresses c-myc; and pMSV-T24-H-ras/MSV-c-myc, which expresses both oncogenes. Tumors were induced in mice by pMSV-T24-H-ras plus pMSV-c-myc or by pMSV-T24-H-ras/MSV-c-myc. Because newborn hamsters and newborn rats have been recommended for oncogenicity testing of the DNA from tumorigenic mammalian cell-substrates used for vaccine production, we evaluated their sensitivity. Newborn hamsters and rats were inoculated with different doses of pMSV-T24-H-ras/MSV-c-myc to determine their sensitivity to tumor induction and with the single-oncogene-expression plasmids to determine whether single oncogenes could induce tumors. Newborn rats were more sensitive than newborn hamsters, and activated H-ras but not c-myc induced tumors in newborns of both rodent species. DNA from four cell lines established from tumors induced by pMSV-T24-H-ras/MSV-c-myc was inoculated into newborn rats. Because no tumors were induced by this cellular DNA, which should be optimal as it contains both oncogenes linked and present in several copies, we conclude that available in vivo models are not sensitive enough to detect the oncogenicity of cellular DNA.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105623000635/pdfft?md5=d21bdd8386ed7631ef26debf1c2101af&pid=1-s2.0-S1045105623000635-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134652940","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

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 : 2023-11-01 DOI: 10.1016/S1045-1056(23)00068-4

引用次数: 0

Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India 用于印度BoHV-1血清监测的重组gD蛋白ELISA的开发和评估。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-01 DOI: 10.1016/j.biologicals.2023.101720

Sushmita Nautiyal , Sukdeb Nandi , Kirtika Sharma , Vivek Gairola , K.G. Sai Balaji , Sanchay Kumar Biswas , Ravikant Agrawal , Sonalika Mahajan , Karam Pal Singh , Gaurav Kumar Sharma

{"title":"Development and evaluation of recombinant gD protein based ELISA for sero-surveillance of BoHV-1 in India","authors":"Sushmita Nautiyal , Sukdeb Nandi , Kirtika Sharma , Vivek Gairola , K.G. Sai Balaji , Sanchay Kumar Biswas , Ravikant Agrawal , Sonalika Mahajan , Karam Pal Singh , Gaurav Kumar Sharma","doi":"10.1016/j.biologicals.2023.101720","DOIUrl":"10.1016/j.biologicals.2023.101720","url":null,"abstract":"<div>Bovine herpes virus-1 (BoHV-1) is responsible for production losses through decreased milk yields, abortions, infertility, and trade restrictions in the bovine population. The disease is endemic in many countries including India. As the virus harbors a unique feature of latency animals once infected with the virus remain sero-positive for lifetime and can re-excrete the virus when exposed to stressful conditions. Hence, identification and culling of infected animals is only the means to minimize infection-associated losses. In this study, an economical indigenous assay for the detection of BoHV-1 specific antibodies was developed to cater to the huge bovine population of the country. The viral structural gD protein, expressed in the prokaryotic system was used for optimization of an indirect ELISA for bovines followed by statistical validation of the assay. The diagnostic sensitivity and specificity of the indirect ELISA were 82.9% and 91.3% respectively. Systematically collected serum samples representing organized, unorganized and breeding farms of India were tested with the indigenously developed assay for further validation.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72016150","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

Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities 将3Rs方法纳入世界卫生组织生物制品批量放行测试指南：对国家控制实验室和国家监管机构的调查回应。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-11-01 DOI: 10.1016/j.biologicals.2023.101721

Elliot Lilley , Martijn Bruysters , Pradip Das , Simeon Gill , Richard Isbrucker , David Jones , Anthony Holmes

{"title":"Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of National Control Laboratories and National Regulatory Authorities","authors":"Elliot Lilley , Martijn Bruysters , Pradip Das , Simeon Gill , Richard Isbrucker , David Jones , Anthony Holmes","doi":"10.1016/j.biologicals.2023.101721","DOIUrl":"10.1016/j.biologicals.2023.101721","url":null,"abstract":"<div>The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) is reviewing World Health Organization (WHO) manuals, guidelines and recommendations for vaccines and biotherapeutics to identify the extent to which animal-based testing methods are described. The aim is to recommend where updates to these documents can lead to an increased and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement of animal tests) in the quality control and batch release testing requirements for vaccines and biotherapeutics. Improved adoption of 3Rs principles and non-animal testing strategies will help to reduce the delays and costs associated with product release testing. Developing recommendations that are widely applicable by both the manufacturers and national regulatory authorities for vaccines and biological therapeutics globally requires a detailed understanding of how different organisations view the opportunities and barriers to better integration of the 3Rs. To facilitate this, we developed and distributed a survey aimed at individuals who work for national regulatory authorities (NRAs) and/or national control laboratories (NCLs). In this paper, we present the key findings from this survey and how these will help inform the recommendations for wider integration of 3Rs approaches by WHO in their guidance documents applicable to the quality control and batch release testing of vaccines and biotherapeutics.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S104510562300060X/pdfft?md5=1ef8f7b03b3983802ab69c33c1d2df62&pid=1-s2.0-S104510562300060X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71489255","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

Corrigendum to “Comparison of Astra Zeneca and sinopharm vaccines as boosters in protection against COVID-19 infection” [Biologicals 82 (2023) 101668] “阿斯利康和国药集团疫苗作为预防新冠肺炎感染的加强剂的比较”更正[生物制品82（2023）101668]。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-20 DOI: 10.1016/j.biologicals.2023.101719

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

引用次数: 0

Virus filtration using small pore virus filter in downstream processing of biotherapeutic products: The effect of operating pressure 在生物治疗产品的下游加工中使用小孔病毒过滤器进行病毒过滤：操作压力的影响。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-12 DOI: 10.1016/j.biologicals.2023.101718

Na Liu, Tiandan Xu

引用次数: 0

Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh 孟加拉国出现感兴趣的严重急性呼吸系统综合征冠状病毒2型变种B.1.525（Eta）。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-05 DOI: 10.1016/j.biologicals.2023.101714

Barna Goswami , Md Murshed Hasan Sarkar , Shahina Akter , Tanjina Akhtar Banu , Iffat Jahan , Md Saddam Hossain , Mohammad Mohi Uddin , Tasnim Nafisa , Md Maruf Ahmed Molla , Mahmuda Yeasmin , Eshrar Osman , Mohammad Samir Uzzaman , Abu Sayeed Mohammad Mahmud , Ahashan Habib , Salim Khan

{"title":"Emergence of SARS-CoV-2 variant of interest B.1.525 (Eta) in Bangladesh","authors":"Barna Goswami , Md Murshed Hasan Sarkar , Shahina Akter , Tanjina Akhtar Banu , Iffat Jahan , Md Saddam Hossain , Mohammad Mohi Uddin , Tasnim Nafisa , Md Maruf Ahmed Molla , Mahmuda Yeasmin , Eshrar Osman , Mohammad Samir Uzzaman , Abu Sayeed Mohammad Mahmud , Ahashan Habib , Salim Khan","doi":"10.1016/j.biologicals.2023.101714","DOIUrl":"10.1016/j.biologicals.2023.101714","url":null,"abstract":"<div>In the present study, we report the complete genome of five Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) from Bangladesh harboring mutations at Spike protein (E484K, Q677H, D614G, A67V, Q52R, Y144del, H69del, V70del, F888L) assigned to the B.1.525 lineage (Variant of interest). Mutations are also found in viral structural proteins other than spike region (E_L21F, M_I82F, N_A12G and N_T208I) and other mutations (NSP3_T1189I, NSP6_S106del, NSP6_F108del, NSP6_G107del, NSP12_P323F) from all of five B.1.525 SARS-CoV-2 variants of Bangladesh. We have also found four unique mutations from two of SARS-CoV-2 B.1.525 variant of Bangladesh. Among the four unique mutations two mutations (NS7a_L96H, NS7a_Y97D) obtained from strain BCSIR-NILMRC-718, one (NSP3_A1430V) from BCSIR-NILMRC-738 and two mutation including one spike protein mutation (NSP2_L444I, Spike_I68 M) present in BCSIR-AFIP-10 strain. The identification of new mutations will contribute to characterizing SARS-CoV-2, to continue tracking its spread and better understanding its biological and clinical features to take medical countermeasures and vaccines.</div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41169903","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