Biologicals最新文献_第7页

Development of an optimized RT-LAMP test for the detection of SARS-CoV-2 用于检测严重急性呼吸系统综合征冠状病毒2型的优化RT-LAMP测试的开发。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-04 DOI: 10.1016/j.biologicals.2023.101716

Navid Momenifar, Mohammad Pirouzfar, Zohreh Hashemian, Abdolreza Daneshvar Amoli

引用次数: 0

Development and evaluation of an external quality control and internal quality control containing real-time RT-PCR assay for the detection of o'nyong-nyong virus 用于检测o'nyong-nyong病毒的外部质量控制和包含实时RT-PCR的内部质量控制的开发和评估。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-04 DOI: 10.1016/j.biologicals.2023.101717

Hai-Bo Wang , Tian Du , Ji-Hong Lin , Xin-Bin Chen , Cheng-Ning Tu

{"title":"Development and evaluation of an external quality control and internal quality control containing real-time RT-PCR assay for the detection of o'nyong-nyong virus","authors":"Hai-Bo Wang , Tian Du , Ji-Hong Lin , Xin-Bin Chen , Cheng-Ning Tu","doi":"10.1016/j.biologicals.2023.101717","DOIUrl":"10.1016/j.biologicals.2023.101717","url":null,"abstract":"<div><p><span><span><span>O'nyong-nyong fever is a mosquito-borne tropical viral disease while few </span>molecular diagnostic<span> tools have been established for its surveillance until now. In the current study, a single-step, dual-color real-time reverse transcription polymerase chain reaction (RT-PCR) assay which contained both external quality control (EQC) and internal quality control (IQC) prepared by armored RNA technique was developed and evaluated for the detection of o'nyong-nyong </span></span>virus<span> (ONNV). Results showed that the assay was established successfully without cross-reaction with genetically related or symptom-alike diseases, which showed high specificity of the assay. The coefficient of variation of the assay was 0.97%, far less than 5%, indicating good repeatability of the assay. The lower limit of detection of the assay could reach as low as 100 copies of genome equivalent. During evaluation, the assay could correctly detect ONNV from spiked human serum samples and </span></span><span><em>Anopheles</em></span> species mosquito samples, while no ONNV positive was observed either from serum samples of patients with acute febrile illness or from local <em>Anopheles</em> species mosquitoes, suggesting no ONNV had been transmitted locally. In conclusion, the assay could potentially provide a valuable platform for ONNV molecular detection, which may improve the preparedness for future o'nyong-nyong fever outbreaks.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41156836","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

Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states 世界卫生组织西太平洋和东南亚成员国疫苗和生物制品国家控制实验室第七次会议报告。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-03 DOI: 10.1016/j.biologicals.2023.101712

Sun Bo Shim , Chan Woong Choi , Jin Ho Shin , Jong Won Kim , Silke Schepelmann , Jae Ho Jung , Harish Chander , Ratih Pujilestari , Madoka Kuramitsu , Masaki Ochiai , Nee Yuan Qi , Geraldine N. Dimapilis , Luu Thi Dung , Hyung Sil Moon , In Soo Shin

{"title":"Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states","authors":"Sun Bo Shim , Chan Woong Choi , Jin Ho Shin , Jong Won Kim , Silke Schepelmann , Jae Ho Jung , Harish Chander , Ratih Pujilestari , Madoka Kuramitsu , Masaki Ochiai , Nee Yuan Qi , Geraldine N. Dimapilis , Luu Thi Dung , Hyung Sil Moon , In Soo Shin","doi":"10.1016/j.biologicals.2023.101712","DOIUrl":"10.1016/j.biologicals.2023.101712","url":null,"abstract":"<div><p>The Biregional Network of National Control Laboratories (NCLs) of the WHO Western Pacific and South-East Asia Regions has been meeting annually since 2018 to enhance NCLs' voluntary participation capacity. Its seventh meeting was hosted by the Korea National Institute of Food and Drug Safety Evaluation (NIFDS) of the Ministry of Food and Drug Safety (MFDS), in conjunction with the Global Bio Conference, in Seoul on September 6, 2022. Over 60 participants from seven countries, (India, Indonesia, Japan, Korea, Malaysia, the Philippines, and Vietnam) attended the meeting on-site and online. The theme of this meeting was ‘<em>Quality Control Issues and International Trends for Biologicals including Vaccines and Plasma-Derived Medicinal Products</em>.’ Three special speeches were presented on sharing the quality control system for biologicals, including NCLs' considerations in preparing the WHO Listed Authorities and sharing MFDS experiences. Furthermore, the participating NCLs shared country-specific issues related to national lot releases during the COVID-19 pandemic and acknowledged the meeting’s crucial role in response preparedness for pandemic emergencies and enhancing regulatory capacity through coalitions and information exchange among NCLs. The NIFDS will cooperate closely with other Asian NCLs to enhance biological product quality control, aiming to establish regional standards and standardize test methods through collaboration.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41169091","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

Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing 生物制药一次性生产的风险评估：上游连续加工的案例研究。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-02 DOI: 10.1016/j.biologicals.2023.101713

Takao ITO , Hui Wang , Soon-Hwa Hwang , Bin Wang , Lizhi Wang , Somasundaram G

{"title":"Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing","authors":"Takao ITO , Hui Wang , Soon-Hwa Hwang , Bin Wang , Lizhi Wang , Somasundaram G","doi":"10.1016/j.biologicals.2023.101713","DOIUrl":"10.1016/j.biologicals.2023.101713","url":null,"abstract":"<div><p>In the current transition to intensified upstream processing, the risks of adopting traditional single-use systems for high-titer, long-duration perfusion cultures, have thus far not been considered. This case study uses the Failure Modes and Effects Analysis (FMEA) method to evaluate the risks associated with implementing upstream single-use technology. The simulated model process was used to compare the risk level of single-use technology for a traditional fed-batch cell culture with that for perfusion culture, under the same annual protein production conditions. To provide a reasonable source of potential risk for FMEA, all single-use upstream operations for both fed-batch and perfusion processes were investigated using an analytical method developed to quantify the impact of process parameters and operating conditions on single-use system specifications and to ensure objectivity. Many of the risks and their levels, were similar in long-duration perfusion cultures and fed-batch cultures. However, differences were observed for high-risk components such as daily sampling and installation. The result of this analysis indicates that the reasons for risk are different for fed-batch cultures and perfusion cultures such as larger bioreactors in fed-batch and longer runs in perfusion, respectively. This risk assessment method could identify additional control measures and be part of a holistic contamination control strategy and help visualize their effectiveness.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41156838","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

In silico discovery of epitopes of gag and env proteins for the development of a multi-epitope vaccine candidate against Maedi Visna Virus using reverse vaccinology approach 在计算机上发现gag和env蛋白的表位，用于使用反向疫苗学方法开发针对Maedi-Visna病毒的多表位候选疫苗。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-10-02 DOI: 10.1016/j.biologicals.2023.101715

Ecem Su Koçkaya , Hüseyin Can , Yalçın Yaman , Cemal Ün

{"title":"In silico discovery of epitopes of gag and env proteins for the development of a multi-epitope vaccine candidate against Maedi Visna Virus using reverse vaccinology approach","authors":"Ecem Su Koçkaya , Hüseyin Can , Yalçın Yaman , Cemal Ün","doi":"10.1016/j.biologicals.2023.101715","DOIUrl":"10.1016/j.biologicals.2023.101715","url":null,"abstract":"<div><p><span><span>Maedi Visna Virus (MVV) causes a chronic </span>viral disease in sheep. Since there is no specific therapeutic </span>drug<span><span><span> that targets MVV, development of a vaccine against the MVV is inevitable. This study aimed to analyze the gag<span> and env proteins as vaccine candidate proteins and to identify epitopes in these proteins. In addition, it was aimed to construct a multi-epitope vaccine candidate. According to the obtained results, the gag protein was detected to be more conserved and had a higher </span></span>antigenicity value. Also, the number of </span>alpha helix<span> in the secondary structure<span> was higher and transmembrane helices were not detected. Although many B cell and MHC-I/II epitopes were predicted, only 19 of them were detected to have the properties of antigenic, non-allergenic, non-toxic, soluble, and non-hemolytic. Of these epitopes, five were remarkable due to having the highest antigenicity value. However, the final multi-epitope vaccine was constructed with 19 epitopes. A strong affinity was shown between the final multi-epitope vaccine and TLR-2/4. In conclusion, the gag protein was a better antigen. However, both proteins had epitopes with high antigenicity value. Also, the final multi-epitope vaccine construct had a potential to be used as a peptide vaccine due to its immuno-informatics results.</span></span></span></p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41156837","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

Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab 抗VEGF单克隆抗体（PRO-169）的糖基化差异及其与贝伐单抗的广泛比较。

IF 1.7 4区生物学

Biologicals Pub Date : 2023-09-23 DOI: 10.1016/j.biologicals.2023.101711

Mayra G. Quiñonez-Alvarado , Paulina Chávez-Hurtado , Jesús C. Caro-Palomera , Oriana L. Niño-Trejo , José I. Jiménez-Dolores , Patricia Muñoz-Villegas , Leopoldo Baiza-Durán , Juan D. Quintana-Hau

{"title":"Glycosylation differences of an anti-VEGF monoclonal antibody (PRO-169) and its extensive comparison with Bevacizumab","authors":"Mayra G. Quiñonez-Alvarado , Paulina Chávez-Hurtado , Jesús C. Caro-Palomera , Oriana L. Niño-Trejo , José I. Jiménez-Dolores , Patricia Muñoz-Villegas , Leopoldo Baiza-Durán , Juan D. Quintana-Hau","doi":"10.1016/j.biologicals.2023.101711","DOIUrl":"10.1016/j.biologicals.2023.101711","url":null,"abstract":"<div><p>PRO-169 is an <em>anti</em>-VEGF monoclonal antibody developed by Laboratorios Sophia that shares its sequence with Bevacizumab (BVZ); though, PRO-169 is intended for intravitreal administration. In this study, analytical characterization showed that PRO-169 had glycosylation differences in comparison to BVZ reference product (RP); since it had more content of G1F, G2F, sialic acid and high mannose. Further investigation was performed to evaluate if differences between both products would affect the efficacy and safety profile of PRO-169.</p><p>PRO-169 had no alteration in its <em>in vitro</em> biological activity; moreover, no cytotoxicity or immunogenicity concerns should be expected as demonstrated by different orthogonal methods at analytical, <em>in vitro</em> and <em>in vivo</em> assays. These results support moving to the clinical testing of PRO-169 since no major complications will be expected with its clinical use for the treatment of ophthalmic diseases.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41175302","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

Regulatory perspective for quality evaluation of lipid nanoparticle-based mRNA vaccines in China 中国基于脂质纳米颗粒的mRNA疫苗质量评价的监管视角

IF 1.7 4区生物学

Biologicals Pub Date : 2023-09-12 DOI: 10.1016/j.biologicals.2023.101700

Jiaqi Lu, Wei Wei, Wu He

引用次数: 0

Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test 校正用于絮凝试验的破伤风类毒素替代国际标准的合作研究

IF 1.7 4区生物学

Biologicals Pub Date : 2023-08-30 DOI: 10.1016/j.biologicals.2023.101701

Rob Tierney, Jason Hockley, Shalini Rajagopal, Paul Stickings

{"title":"Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation test","authors":"Rob Tierney, Jason Hockley, Shalini Rajagopal, Paul Stickings","doi":"10.1016/j.biologicals.2023.101701","DOIUrl":"10.1016/j.biologicals.2023.101701","url":null,"abstract":"<div><p>Here we report the results of a study to establish a replacement WHO International Standard (IS) for tetanus toxoid for use in flocculation test. The standard was calibrated in flocculation units (Lf) against the 2nd IS using the Ramon flocculation method. At its 70th meeting in October 2019, WHO ECBS established the material (coded 16/302) as the 3rd WHO IS, with an assigned value of 970 Lf/ampoule from the results of seventeen laboratories across ten different countries.</p><p>The study also provided an opportunity to assess the use of alternative methods for measuring Lf. Participants were asked to use an in-house Enzyme Linked Immunosorbent Assay (ELISA) developed at NIBSC, or other suitable in-house methods, to determine ELISA-specific Lf values (Lf-eq units are specific only for pre-calibration of antitoxin in the flocculation test) of 16/302 to compare to those of the flocculation test. Nine laboratories participated by performing the NIBSC ELISA, one laboratory performed flocculation by laser light-scattering following an in-house protocol, and three laboratories performed ELISA following in-house protocols. The results intimate that these alternative methods could be useful for monitoring consistency of production at different stages of vaccine manufacturing.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10138632","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 future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report 热原试验的未来:逐步淘汰兔热原试验。会议报告

IF 1.7 4区生物学

Biologicals Pub Date : 2023-08-27 DOI: 10.1016/j.biologicals.2023.101702

Gwenaël Cirefice , Katrin Schütte , Ingo Spreitzer , Emmanuelle Charton , Shahjahan Shaid , Laura Viviani , Michelle Rubbrecht , Irene Manou

{"title":"The future of pyrogenicity testing: Phasing out the rabbit pyrogen test. A meeting report","authors":"Gwenaël Cirefice , Katrin Schütte , Ingo Spreitzer , Emmanuelle Charton , Shahjahan Shaid , Laura Viviani , Michelle Rubbrecht , Irene Manou","doi":"10.1016/j.biologicals.2023.101702","DOIUrl":"10.1016/j.biologicals.2023.101702","url":null,"abstract":"<div><p>The rabbit pyrogen test (RPT) was the benchmark for pyrogenicity testing, but scientific advancements have provided innovative and humane methods, such as the <em>in vitro</em> monocyte-activation test (MAT). However, transitioning from the RPT to the MAT has been challenging. The European Directorate for the Quality of Medicines & HealthCare, the Council of Europe, and the European Partnership for Alternative Approaches to Animal Testing jointly hosted an international conference entitled \"The future of pyrogenicity testing: phasing out the rabbit pyrogen test\". The conference aimed to show how the European Pharmacopoeia intends to remove the RPT from its texts by 2026, facilitate the use of MAT, and identify gaps in the suppression of RPT. The events contributed to a better understanding of the barriers to RPT replacement and acceptance of <em>in vitro</em> alternatives. Participants comprised stakeholders from Asia, Europe, and North America, including vaccine developers, contract laboratories, and regulators. Participants shared their replacement strategies and experiences with MAT implementation. They emphasised the need for continued cooperation between stakeholders and stressed the importance of international harmonisation of regulatory requirements to help accelerate MAT acceptance outside Europe. Despite the challenges, the willingness to eliminate the unnecessary use of RPT was common across all participants.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10112007","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

Confirming the absence of parental African swine fever virus as a potential contaminant of recombinant live attenuated ASF vaccines 证实重组非洲猪瘟减毒活疫苗中不存在非洲猪瘟亲本病毒作为潜在污染物

IF 1.7 4区生物学

Biologicals Pub Date : 2023-08-01 DOI: 10.1016/j.biologicals.2023.101685

Lauro Velazquez-Salinas , Elizabeth Ramirez-Medina , Ayushi Rai , Sarah Pruitt , Elizabeth A. Vuono , Nallely Espinoza , Cyril G. Gay , Steve Witte , Douglas P. Gladue , Manuel V. Borca

{"title":"Confirming the absence of parental African swine fever virus as a potential contaminant of recombinant live attenuated ASF vaccines","authors":"Lauro Velazquez-Salinas , Elizabeth Ramirez-Medina , Ayushi Rai , Sarah Pruitt , Elizabeth A. Vuono , Nallely Espinoza , Cyril G. Gay , Steve Witte , Douglas P. Gladue , Manuel V. Borca","doi":"10.1016/j.biologicals.2023.101685","DOIUrl":"10.1016/j.biologicals.2023.101685","url":null,"abstract":"<div><p>African swine fever (ASF) is a devastating disease that is currently producing a panzootic significantly impacting the swine industry worldwide. One of the major challenges for advancing the development of ASF vaccines has been the absence of international standards for ASF vaccine purity, potency, safety, and efficacy. To date, the most effective experimental vaccines have been live attenuated strains of viruses. Most of these promising vaccine candidates have been developed by deleting virus genes involved in the process of viral pathogenesis and disease production. This approach requires genomic modification of a parental virus field strain through a process of homologous recombination followed by purification of the recombinant attenuated virus. In this scenario, it is critical to confirm the absence of any parental virulent virus in the final virus stock used for vaccine production. We present here a protocol to establish the purity of virus stock using the live attenuated vaccine candidates ASFV-G-ΔMGF, ASFV-G-Δ9 GLΔUK and ASFV-G-ΔI177L. Procedures described here includes inoculation in susceptible pigs followed by the assessment of the obtained material by differential qPCRs that allows the identification of vaccine virus from ASFV field isolates. This protocol is proposed as a model to ensure that master seed virus stock used for vaccine production does not contain residual parental virulent virus.</p><p>Procedures described here includes a passage in susceptible pigs followed by the assessment of the obtained material by differential qPCRs that allows the identification of vaccine virus from ASFV field isolates.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10602226","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