Biologicals最新文献_第6页

From discovery to innovation in animal health: Maturing emerging technologies for industrial development 动物保健从发现到创新：成熟新兴技术，促进产业发展。

IF 1.5 4区生物学

Biologicals Pub Date : 2024-08-01 DOI: 10.1016/j.biologicals.2024.101783

Johannes Charlier , Laetitia Cicchelero , Alexandra PM. Cloherty , Emmanuel Hanon , Matthias Hofer , Filip Goossens , Sven Arnouts

{"title":"From discovery to innovation in animal health: Maturing emerging technologies for industrial development","authors":"Johannes Charlier , Laetitia Cicchelero , Alexandra PM. Cloherty , Emmanuel Hanon , Matthias Hofer , Filip Goossens , Sven Arnouts","doi":"10.1016/j.biologicals.2024.101783","DOIUrl":"10.1016/j.biologicals.2024.101783","url":null,"abstract":"<div><p>The Discovery to Innovation in Animal Health Conference (DIAH) was organised to bridge the gap between early developers, including academia, regulators, research organizations, and spin-offs/start-ups on one side, and medium-to large-sized companies on the other. The DIAH Conference confronted and aligned vision from academia, industry and regulators, emphasizing the need for early collaboration, careful IP management, and strategic planning for successful product development and partnerships. Recent breakthroughs in vaccinology have not only accelerated the vaccine production process but have also improved antigen quality significantly. These novel technologies are likely to transform vaccine development and play a crucial role in addressing both immediate health challenges (such as cancer vaccines) and ensuring preparedness for future pandemics. The potential and pitfalls of leveraging AI to drive forward R&I activities in the field of animal health were also discussed. Researchers and entrepreneurs looking for collaboration or investment presented a series of new technologies and start-ups, respectively. A market analysis showed that the animal health industry, while highly consolidated, also shows great diversity, ranging from big pharma to companies offering diagnostics, nutritional health services, wearables, feed additives, animal feed and genetic analyses. An analysis of the investment landscape, although subject to external factors, showed that the chances for success are high when good science, a well established regulatory pathways, with a clearly defined market need can be combined with experienced management and a strong investor consortium.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101783"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S104510562400040X/pdfft?md5=ff3bae505f228f6b975ba26e1d4edf17&pid=1-s2.0-S104510562400040X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861747","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

Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines 设计针对人类巨细胞病毒的多表位疫苗，整合泛基因组和反向疫苗学流水线

IF 1.5 4区生物学

Biologicals Pub Date : 2024-07-13 DOI: 10.1016/j.biologicals.2024.101782

Rhitam Biswas , Rayapadi G. Swetha , Soumya Basu , Aditi Roy , Sudha Ramaiah , Anand Anbarasu

{"title":"Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines","authors":"Rhitam Biswas , Rayapadi G. Swetha , Soumya Basu , Aditi Roy , Sudha Ramaiah , Anand Anbarasu","doi":"10.1016/j.biologicals.2024.101782","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101782","url":null,"abstract":"<div><p>Human cytomegalovirus (HCMV) is accountable for high morbidity in neonates and immunosuppressed individuals. Due to the high genetic variability of HCMV, current prophylactic measures are insufficient. In this study, we employed a pan-genome and reverse vaccinology approach to screen the target for efficient vaccine candidates. Four proteins, envelope glycoprotein M, UL41A, US23, and US28, were shortlisted based on cellular localization, high solubility, antigenicity, and immunogenicity. A total of 29 B-cell and 44 T-cell highly immunogenic and antigenic epitopes with high global population coverage were finalized using immunoinformatics tools and algorithms. Further, the epitopes that were overlapping among the finalized B-cell and T-cell epitopes were linked with suitable linkers to form various combinations of multi-epitopic vaccine constructs. Among 16 vaccine constructs, Vc12 was selected based on physicochemical and structural properties. The docking and molecular simulations of V<sub>C</sub>12 were performed, which showed its high binding affinity (−23.35 kcal/mol) towards TLR4 due to intermolecular hydrogen bonds, salt bridges, and hydrophobic interactions, and there were only minimal fluctuations. Furthermore, Vc12 eliciting a good response was checked for its expression in <em>Escherichia coli</em> through <em>in silico</em> cloning and codon optimization, suggesting it to be a potent vaccine candidate.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101782"},"PeriodicalIF":1.5,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141607714","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

Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y 评估脑膜炎球菌荚膜多糖 W 和 Y 组候选国际标准

IF 1.5 4区生物学

Biologicals Pub Date : 2024-07-05 DOI: 10.1016/j.biologicals.2024.101780

Hannah Chan , Nicola Beresford , Timothy R. Rudd , Peter Rigsby , Caroline Vipond , Fang Gao , Paul Matejtschuk , Kiran Malik , Chinwe Duru , Eleanor Atkinson , Karena Burkin , Gianluigi De Benedetto , Kay Lockyer , Barbara Bolgiano , the MenW/MenY IS Working Group

{"title":"Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y","authors":"Hannah Chan , Nicola Beresford , Timothy R. Rudd , Peter Rigsby , Caroline Vipond , Fang Gao , Paul Matejtschuk , Kiran Malik , Chinwe Duru , Eleanor Atkinson , Karena Burkin , Gianluigi De Benedetto , Kay Lockyer , Barbara Bolgiano , the MenW/MenY IS Working Group","doi":"10.1016/j.biologicals.2024.101780","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101780","url":null,"abstract":"<div><p>Two candidate International Standards for meningococcal capsular group W and Y (MenW and MenY, respectively) polysaccharides were assessed for their suitability as quantitative standards in various physicochemical assays. The study was designed to evaluate the intended purpose of these standards, namely, to standardize the quantification of the respective polysaccharide content in meningococcal polysaccharide and conjugate vaccines and their intermediate components. Twelve laboratories from eleven different countries participated in the collaborative study of candidate preparations for International Standards for MenW and MenY polysaccharide (coded 16/152 and 16/206, respectively). Unitage was assigned using the Resorcinol assay. Our proposals, on the basis of data from the Resorcinol assay were: 1) candidate standard for MenW polysaccharide (16/152) to be assigned a content of 1.015 ± 0.071 mg MenW polysaccharide per ampoule (expanded uncertainty with coverage factor k = 2.13, corresponding to a 95 % level of confidence) and 2) candidate standard for MenY polysaccharide (16/206) be assigned a content of 0.958 ± 0.076 mg MenY polysaccharide per ampoule (expanded uncertainty with coverage factor k = 2.26, corresponding to a 95 % level of confidence). The amount of polysaccharide per ampoule remained consistent under all stability conditions over a 36-month period.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101780"},"PeriodicalIF":1.5,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S104510562400037X/pdfft?md5=628d903386d6768c44afa515e287b16a&pid=1-s2.0-S104510562400037X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141543775","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

COVID-19: A case for plasma derived natural anticoagulants? COVID-19：血浆衍生天然抗凝剂的案例？

IF 1.5 4区生物学

Biologicals Pub Date : 2024-06-25 DOI: 10.1016/j.biologicals.2024.101781

Rainer Seitz , Lutz Gürtler , Wolfgang Schramm

引用次数: 0

It is time to reconsider the use of naturally-occurring endotoxins in endotoxin recovery studies: Part 2 of a BioPhorum harmonized endotoxin recovery study 是时候重新考虑在内毒素恢复研究中使用天然内毒素了：BioPhorum 统一内毒素恢复研究的第二部分

IF 1.5 4区生物学

Biologicals Pub Date : 2024-06-21 DOI: 10.1016/j.biologicals.2024.101779

Jay Bolden , Michael Knight , Jordan Montz , Jeff One , Share Stockman , Steven P. Jones

{"title":"It is time to reconsider the use of naturally-occurring endotoxins in endotoxin recovery studies: Part 2 of a BioPhorum harmonized endotoxin recovery study","authors":"Jay Bolden , Michael Knight , Jordan Montz , Jeff One , Share Stockman , Steven P. Jones","doi":"10.1016/j.biologicals.2024.101779","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101779","url":null,"abstract":"<div><p>The evaluation of Naturally Occurring Endotoxins (NOEs) for Low Endotoxin Recovery (LER) studies has been a topic in the industry and regulatory agencies have been hesitant to endorse NOE use in LER studies over purified Lipopolysaccharide (LPS) standards such as Control Standard Endotoxin (CSE) or Reference Standard Endotoxin (RSE). In a recent study involving 11 BioPhorum member companies across 13 sites, NOEs prepared in high and low nutrient conditions were evaluated in two common monoclonal antibody buffer formulations: 10 mM Sodium Citrate, 0.05 % Polysorbate 80, pH 6.0 and 20 mM Histidine, 0.05 % Polysorbate 80, pH 6.0. 12 g-negative bacterial isolates were used to prepare NOE analytes, which were spiked into the formulation buffers. Additionally, the NOEs were spiked into Limulus Amebocyte Lysate (LAL) reagent water as controls and purified LPS into the citrate/polysorbate buffer as the LER control. Results showed the average of three runs per organism was >50 % recovery, at the conclusion of the 7-day period, regardless of nutrient culture preparation conditions. Furthermore, purified LPS controls became undetectable (<50 % recovery) in the citrate/polysorbate buffer, highlighting the presence of LER. These findings highlight the potential value of using NOEs from relevant manufacturing facilities to assess overall risk when purified LPS recovery is insufficient.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101779"},"PeriodicalIF":1.5,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000368/pdfft?md5=cd82d401289c99d164868f827850f4a9&pid=1-s2.0-S1045105624000368-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141438640","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

Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea 韩国血浆衍生药物国家批次放行监管框架概览

IF 1.7 4区生物学

Biologicals Pub Date : 2024-05-01 DOI: 10.1016/j.biologicals.2024.101768

Su Kyoung Seong , Young Hoon Kim , Youngju Choi , Hyun Jung Koh , Seong Jae Kim , Myoung Jun Kim , Chan Woong Choi

{"title":"Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea","authors":"Su Kyoung Seong , Young Hoon Kim , Youngju Choi , Hyun Jung Koh , Seong Jae Kim , Myoung Jun Kim , Chan Woong Choi","doi":"10.1016/j.biologicals.2024.101768","DOIUrl":"https://doi.org/10.1016/j.biologicals.2024.101768","url":null,"abstract":"<div><p>Plasma-derived medicinal products (PDMPs) are essential in the treatment of acute and chronic life-threatening diseases. The Korea Ministry of Food and Drug Safety has conducted a national lot release (NLR) of PDMPs since 2012 based on a summary protocol review system and lot release testing. However, few studies have investigated the performance or characteristics of the NLR framework. Over the past decade, the NLR of PDMPs was approximately 1000 per year, including mainly albumins, immunoglobulins, fibrin sealant kits, and coagulation factors, among others. The NLR system for PDMPs is similar to that for vaccines, except that PDMPs are manufactured using human plasma, which requires strict safety management. This study describes the status of NLR procedures for PDMPs and outlines the regulatory requirements needed to safely manage plasma for fractionation in Korea. This study can aid national control laboratories and marketing authorization holders in developing regulatory systems that assure the availability of safe and effective PDMPs.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"86 ","pages":"Article 101768"},"PeriodicalIF":1.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000253/pdfft?md5=5d5325932d9d480f5b4295c61defa0f1&pid=1-s2.0-S1045105624000253-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140902014","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

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 DOI: 10.1016/j.biologicals.2014.06.001

John Petricciani, Ivana Knezevic

引用次数: 0

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 DOI: 10.1016/j.biologicals.2024.101766

Muhammad Tahir Hayat, Mariam Badam, Javaria Qazi

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 DOI: 10.1016/S1045-1056(24)00031-9

引用次数: 0

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 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