Biologicals最新文献_第8页

Animal cell substrates for the production of biologicals: An introduction to WHO documents 用于生产生物制品的动物细胞基质：世界卫生组织文件简介。

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2014-12-09 DOI: 10.1016/j.biologicals.2014.06.001

John Petricciani, Ivana Knezevic

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From eradication to re-emergence: The changing landscape of polio in the cVDPV2 era 从根除到重新出现：cVDPV2 时代脊髓灰质炎的格局变化

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-05-03 DOI: 10.1016/j.biologicals.2024.101766

Muhammad Tahir Hayat, Mariam Badam, Javaria Qazi

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pH inactivation of SARS-CoV-2 and SARS-CoV in virus spiked protein A eluates from a mAb purification process 在 mAb 纯化过程中，通过 pH 值灭活加有病毒的蛋白 A 洗脱液中的 SARS-CoV-2 和 SARS-CoV

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-03-15 DOI: 10.1016/j.biologicals.2024.101753

Hannah Limburg , Marie Schwerdtner , Eileen Wilson , Bernhard Roth , Jean-Pol Cassart , Anke-Dorothee Werner , Anne Harbig , Eva Böttcher-Friebertshäuser , Anne Stokes

{"title":"pH inactivation of SARS-CoV-2 and SARS-CoV in virus spiked protein A eluates from a mAb purification process","authors":"Hannah Limburg , Marie Schwerdtner , Eileen Wilson , Bernhard Roth , Jean-Pol Cassart , Anke-Dorothee Werner , Anne Harbig , Eva Böttcher-Friebertshäuser , Anne Stokes","doi":"10.1016/j.biologicals.2024.101753","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101753","url":null,"abstract":"<div><p>Biopharmaceutical manufacturing processes may include a low pH treatment step as a means of inactivating enveloped viruses. Small scale virus clearance studies are routinely performed using model enveloped viruses such as murine leukemia virus to assess inactivation at the pH range used in the downstream manufacturing process. Further, as a means of bioburden reduction, chromatography resins may be cleaned and stored using sodium hydroxide and this can also inactivate viruses. The susceptibility of SARS-CoV-2 and SARS-CoV to low pH conditions using protein A eluate derived material from a monoclonal antibody production process as well as high pH cleaning conditions was addressed. SARS-CoV-2 was effectively inactivated at pH 3.0, moderately inactivated at pH 3.4, but not inactivated at pH 3.8. Low pH was less effective at inactivating SARS-CoV. Both viruses were inactivated at a high pH of ca.13.4. These studies provide important information regarding the effectiveness of viral clearance and inactivation steps of novel coronaviruses when compared to other enveloped viruses.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101753"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140134878","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 : 2024-05-01 Epub Date: 2024-06-07 DOI: 10.1016/S1045-1056(24)00031-9

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Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays 韩国导致猪繁殖障碍的病毒病原体的流行情况及多重实时 PCR 和 RT-PCR 检测方法的开发

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-04-18 DOI: 10.1016/j.biologicals.2024.101763

Go-Eun Shin , Kyoung-Ki Lee , Bok-Kyung Ku , Su Hong Oh , Sang-Ho Jang , Bokyu Kang , Hye-Young Jeoung

{"title":"Prevalence of viral agents causing swine reproductive failure in Korea and the development of multiplex real-time PCR and RT-PCR assays","authors":"Go-Eun Shin , Kyoung-Ki Lee , Bok-Kyung Ku , Su Hong Oh , Sang-Ho Jang , Bokyu Kang , Hye-Young Jeoung","doi":"10.1016/j.biologicals.2024.101763","DOIUrl":"10.1016/j.biologicals.2024.101763","url":null,"abstract":"<div><p>This study aimed to investigate the prevalence of viral agents causing reproductive failure in pigs in Korea. In addition, two types of multiplex real-time PCR (mqPCR) were developed for the simultaneous detection of Aujeszky's disease virus (ADV) and porcine parvovirus (PPV) in mqPCR and encephalomyocarditis virus (EMCV) and Japanese encephalitis virus (JEV) in reverse transcription mqPCR (mRT-qPCR). A total of 150 aborted fetus samples collected from 2020 to 2022 were analyzed. Porcine reproductive and respiratory syndrome virus was the most prevalent (49/150 32.7%), followed by porcine circovirus type 2 (31/150, 20.7%), and PPV1 (7/150, 4.7%), whereas ADV, EMCV, and JEV were not detected. The newly developed mqPCR and mRT-qPCR could simultaneously detect and differentiate with high sensitivities and specificities. When applied to aborted fetuses, the newly developed mqPCR for PPV was 33.3% more sensitivities than the previously established diagnostic method. Amino acid analysis of the VP2 sequences of PPV isolates revealed considerable similarity to the highly pathogenic Kresse strain. This study successfully evaluated the prevalence of viral agents causing reproductive failure among swine in Korea, the developed mqPCR and mRT-qPCR methods could be utilized as effective and accurate diagnostic methods for the epidemiological surveillance of ADV, PPV, EMCV, and JEV.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101763"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140805433","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 of a collaborative study to establish the first Indian Pharmacopoeia reference standard for teriparatide 建立首个印度药典特立帕肽参考标准的合作研究报告

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-03-12 DOI: 10.1016/j.biologicals.2024.101755

Gaurav Pratap Singh Jadaun , M. Kalaivani , Mukesh Kumar , Gyanendra Nath Singh , Rajeev Singh Raghuvanshi , Parveen Jain , Participants of the Study

引用次数: 0

Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines 验证用于检测不定病毒的新一代测序方法：在多种细胞系中证明灵敏度。

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-05-19 DOI: 10.1016/j.biologicals.2024.101771

Rebecca A. Bova, Leyla Diaz, Scott Eubank, Amber Overgard, Alison Armstrong, Bradley Hasson

{"title":"Validation of a next generation sequencing method for adventitious virus detection: Demonstration of sensitivity in multiple cell lines","authors":"Rebecca A. Bova, Leyla Diaz, Scott Eubank, Amber Overgard, Alison Armstrong, Bradley Hasson","doi":"10.1016/j.biologicals.2024.101771","DOIUrl":"10.1016/j.biologicals.2024.101771","url":null,"abstract":"<div><p>In the past few years NGS has become the technology of choice to replace animal-based virus safety methods and this has been strengthened by the recent revision to the ICHQ5A virus safety chapter. Here we describe the validation of an NGS method using an agnostic analysis to detect and identify RNA virus and actively replicating DNA virus contaminants in cell banks. We report the results of the validation of each step in the sequencing process that established quality criteria to ensure consistent sequencing data. Furthermore, the validation of the analysis algorithm designed to identify virus specific sequences is described along with steps undertaken to ensure the integrity of the sequencing data from generation to analysis. Lastly, the validated sequencing and analysis systems were used to establish a limit of detection (LOD) for model viruses in cells that are commonly used in biomanufacturing. The LOD from these studies ranged from 1E+03 to 1E+04 genome copies and were dependent on the virus type with little variability between the different cell types. Thus, the validation of the NGS method for adventitious agent testing and the establishment of a general LOD for cell-based samples provides a suitable alternative to traditional virus detection methods.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101771"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000289/pdfft?md5=597f955402c554c0175fd90d4e780160&pid=1-s2.0-S1045105624000289-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066229","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

Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness 针对猴痘病毒的新型多表位混合疫苗的设计与计算评估：大流行准备工作的潜在目标和免疫原性评估。

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-05-14 DOI: 10.1016/j.biologicals.2024.101770

Allah Rakha Yaseen , Muhammad Suleman , Aqsa Jabeen , Laiba Nezami , Abdul Salam Qadri , Ayesha Arif , Iram Arshad , Khadija Iqbal , Tasuduq Yaqoob , Zoha Khan

{"title":"Design and computational evaluation of a novel multi-epitope hybrid vaccine against monkeypox virus: Potential targets and immunogenicity assessment for pandemic preparedness","authors":"Allah Rakha Yaseen , Muhammad Suleman , Aqsa Jabeen , Laiba Nezami , Abdul Salam Qadri , Ayesha Arif , Iram Arshad , Khadija Iqbal , Tasuduq Yaqoob , Zoha Khan","doi":"10.1016/j.biologicals.2024.101770","DOIUrl":"10.1016/j.biologicals.2024.101770","url":null,"abstract":"<div><p>Monkeypox is a type of DNA-enveloped virus that belongs to the orthopoxvirus family, closely related to the smallpox virus. It can cause an infectious disease in humans known as monkeypox disease. Although there are multiple drugs and vaccines designed to combat orthopoxvirus infections, with a primary focus on smallpox, the recent spread of the monkeypox virus to over 50 countries have ignited a mounting global concern. This unchecked viral proliferation has raised apprehensions about the potential for a pandemic corresponding to the catastrophic impact of COVID-19. This investigation explored the structural proteins of monkeypox virus as potential candidates for designing a novel hybrid multi-epitope vaccine. The epitopes obtained from the selected proteins were screened to ensure their non-allergenicity, non-toxicity, and antigenicity to trigger T and B-cell responses. The interaction of the vaccine with toll-like receptor-3 (TLR-3) and major histocompatibility complexes (MHCs) was assessed using Cluspro 2.0. To establish the reliability of the docked complexes, a comprehensive evaluation was conducted using Immune and MD Simulations and Normal Mode Analysis. However, to validate the computational results of this study, additional in-vitro and in-vivo research is essential.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101770"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140946615","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

Standards for fecal microbiota transplant: Tools and therapeutic advances 粪便微生物群移植标准：工具和治疗进展

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-03-21 DOI: 10.1016/j.biologicals.2024.101758

Ilia Belotserkovsky , Lisa M. Stabryla , Monique Hunter , Jessica Allegretti , Benjamin J. Callahan , Paul E. Carlson , Phillip J. Daschner , Maryam Goudarzi , Cyril Guyard , Scott A. Jackson , Krishna Rao , Stephanie L. Servetas , Harry Sokol , Jennifer A. Wargo , Shawn Novick

{"title":"Standards for fecal microbiota transplant: Tools and therapeutic advances","authors":"Ilia Belotserkovsky , Lisa M. Stabryla , Monique Hunter , Jessica Allegretti , Benjamin J. Callahan , Paul E. Carlson , Phillip J. Daschner , Maryam Goudarzi , Cyril Guyard , Scott A. Jackson , Krishna Rao , Stephanie L. Servetas , Harry Sokol , Jennifer A. Wargo , Shawn Novick","doi":"10.1016/j.biologicals.2024.101758","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101758","url":null,"abstract":"<div><p>Fecal microbiota transplantation (FMT) has been demonstrated to be efficacious in preventing recurrent <em>Clostridioides difficile</em> (<em>C. difficile</em>) infections, and is being investigated for treatment of several other diseases including inflammatory bowel disease, cancer, obesity, liver disease, and diabetes. To speed up the translation of FMT into clinical practice as a safe and standardized therapeutic intervention, additional evidence-based technical and regulatory guidance is needed. To this end in May of 2022, the International Alliance for Biological Standardization (IABS) and the BIOASTER Microbiology Technology Institute hosted a second webinar to discuss key issues still impeding the advancement and standardization of FMT. The goal of this two-day webinar was to provide a forum for scientific experts to share and discuss data and key challenges with one another. Discussion included a focus on the evaluation of safety, efficacy, clinical trial design, reproducibility and accuracy in obtained microbiome measurements and data reporting, and the potential for standardization across these areas. It also focused on increasing the application potential and visibility of FMT beyond treating <em>C. difficile</em> infections.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101758"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140187143","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

Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities 通过使用标准保持疫苗质量：当前的挑战和未来的机遇

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 Epub Date: 2024-03-12 DOI: 10.1016/j.biologicals.2024.101756

Nancy C. Sajjadi , Ryan Brady , Carmen Jungbäck , Laurent Mallet , Catherine Milne , Sandra Prior , Gayle Pulle , Peter Rigsby , Tim Schofield , Richard Siggers , Dean Smith , Paul Stickings , Sylvie Uhlrich , Wim Van Molle , Angela Walker , Tong Wu , Tiequn Zhou , Maria Baca-Estrada

{"title":"Maintaining the quality of vaccines through the use of standards: Current challenges and future opportunities","authors":"Nancy C. Sajjadi , Ryan Brady , Carmen Jungbäck , Laurent Mallet , Catherine Milne , Sandra Prior , Gayle Pulle , Peter Rigsby , Tim Schofield , Richard Siggers , Dean Smith , Paul Stickings , Sylvie Uhlrich , Wim Van Molle , Angela Walker , Tong Wu , Tiequn Zhou , Maria Baca-Estrada","doi":"10.1016/j.biologicals.2024.101756","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101756","url":null,"abstract":"<div><p>An international hybrid meeting held 21–22 June 2023 in Ottawa, Canada brought together regulators, scientists, and industry experts to discuss a set of principles and best practices in the development and implementation of standards. Although the use of international standards (ISs) and international units (IUs) has been an essential part of ensuring human and animal vaccine quality in the past decades, the types and uses of standards have expanded with technological advances in manufacture and testing of vaccines. The needs of stakeholders are evolving in response to the ever-increasing complexity, diversity, and number of vaccine products as well as increasing efforts to replace animal-based potency tests with <em>in vitro</em> assays that measure relevant quality attributes. As such, there must be a concomitant evolution in the design and implementation of both international and in-house standards. Concomitantly, greater harmonization of regulatory expectations must be achieved through collaboration with standard-setting organizations, national control laboratories and manufacturers. Stakeholders provided perspectives on challenges and several recommendations emerged as essential to advancing agreed upon objectives.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101756"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140104030","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