Biologicals最新文献

{"title":"A species-independent indirect-ELISA for detection of antibodies to the non-structural protein 2B of foot-and-mouth disease virus","authors":"Jitendra K. Biswal ,&nbsp;Samarendra Das ,&nbsp;Jajati K. Mohapatra,&nbsp;Manoranjan Rout,&nbsp;Rajeev Ranjan,&nbsp;Rabindra Prasad Singh","doi":"10.1016/j.biologicals.2024.101785","DOIUrl":"10.1016/j.biologicals.2024.101785","url":null,"abstract":"<div><p>Diagnostic assays that are able to detect foot-and-mouth disease (FMD) virus infection in the vaccinated population are essential tools in the progressive control pathway for the FMD. However, testing of serum samples using a single diagnostic assay may not completely substantiate freedom from the virus infection. Therefore, viral non-structural proteins (NSPs)-based various serological assays have been developed for the detection of FMD infection. Nevertheless, the NSPs-based ELISAs have been developed in the indirect-ELISA format, thereby necessitating the use of species-specific conjugated secondary-antibodies for the detection of anti-NSP antibodies in various FMD-susceptible species. Therefore, this study presents a novel recombinant 2B-NSP-based indirect ELISA, employing HRP-conjugated protein-A/G detection system which can detect anti-NSPs antibodies from multiple FMD-susceptible species in a single ELISA platform. Recombinant 2B (r2B) protein was expressed as His-SUMO tagged protein in the <em>E. Coli</em> cells and purified using NI-NTA affinity column chromatography. Using the r2B protein and HRP-conjugated protein A/G, an indirect ELISA was developed and validated for the detection of anti-2B antibodies in serum samples collected from multiple FMD-susceptible animal species with known FMD status. Further, a resampling based statistical technique has been reported for determination of optimal cut-off value for the diagnostic assay. Through this technique, the optimal cut-off of 44 percentage of positivity value was determined for the assay. At this optimal cut-off value, the developed diagnostic assay provided diagnostic sensitivity, specificity, and accuracy, positive and negative predictive values (PPV and NPV) of 92.35 %, 98.41 %, 95.21 %, 98.58 %, and 91.67 %, respectively. The assay was validated further by analyzing random serum samples collected across multi-locations in India. The assay can be used as a single platform for testing serum samples from different species of FMDV-susceptible animals and will be useful for NSP-based serosurveillance of FMDV.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101785"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141914670","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}

{"title":"Aims and Scope/Editorial Board/Publishing Details","authors":"","doi":"10.1016/S1045-1056(24)00046-0","DOIUrl":"10.1016/S1045-1056(24)00046-0","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101789"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000460/pdfft?md5=2d0c569e6d2eaee163701a38190d4864&pid=1-s2.0-S1045105624000460-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142121833","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}

{"title":"COVID-19: A case for plasma derived natural anticoagulants?","authors":"Rainer Seitz ,&nbsp;Lutz Gürtler ,&nbsp;Wolfgang Schramm","doi":"10.1016/j.biologicals.2024.101781","DOIUrl":"10.1016/j.biologicals.2024.101781","url":null,"abstract":"<div><p>Convalescent plasma was proposed for passive immunization against COVID-19; but so far there are conflicting results and still open questions. However, besides antibodies, other plasma proteins may be good candidates for further research and application. Thromboinflammation frequently complicates severe COVID-19, and classical anticoagulants like heparins seem to have limited effect. The natural protease inhibitors antithrombin III (ATIII), α₁-antitrypsin (α₁-AT) and α₂-macroglobulin (α₂-M), which are found decreased in severe COVD-19, play a crucial role in prothrombotic and inflammatory pathways. While ATIII and α₁-AT are licensed as commercially prepared therapeutic concentrates, there is no preparation of α₂-M available. The diagnostic, prognostic, and even therapeutic potential of plasma protease inhibitors should be further explored.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101781"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1045105624000381/pdfft?md5=6594e9480424f6636a37840cfe8dcf6f&pid=1-s2.0-S1045105624000381-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460888","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}

{"title":"Evaluation of candidate International Standards for meningococcal capsular polysaccharide groups W and Y","authors":"Hannah Chan ,&nbsp;Nicola Beresford ,&nbsp;Timothy R. Rudd ,&nbsp;Peter Rigsby ,&nbsp;Caroline Vipond ,&nbsp;Fang Gao ,&nbsp;Paul Matejtschuk ,&nbsp;Kiran Malik ,&nbsp;Chinwe Duru ,&nbsp;Eleanor Atkinson ,&nbsp;Karena Burkin ,&nbsp;Gianluigi De Benedetto ,&nbsp;Kay Lockyer ,&nbsp;Barbara Bolgiano ,&nbsp;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":"2024-08-01","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}

{"title":"Risk management for viral clearance: A case study on adoption of platform validation approach and risk management of process changes","authors":"Na Liu,&nbsp;Runze Wu","doi":"10.1016/j.biologicals.2024.101786","DOIUrl":"10.1016/j.biologicals.2024.101786","url":null,"abstract":"<div><p>Viral clearance (VC) studies are routinely required prior to entering clinical trials or for commercial launch of biopharmaceuticals. With increasing prior knowledge and experience, platform validation can be used to eliminate some VC studies and such strategy has been updated into industry guidelines, such as ICH Q5A (R2). In addition, process changes can happen during life-cycle management of a product. In these circumstances, high-risk process parameters need to be identified and corresponding control strategies need to be defined to ensure viral safety of the product. This work describes the design of a science-based risk management tool and how this tool is employed for platform validation and process change scenarios.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101786"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977264","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}

{"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 ,&nbsp;Michael Knight ,&nbsp;Jordan Montz ,&nbsp;Jeff One ,&nbsp;Share Stockman ,&nbsp;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 &gt;50 % recovery, at the conclusion of the 7-day period, regardless of nutrient culture preparation conditions. Furthermore, purified LPS controls became undetectable (&lt;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":"2024-08-01","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}

{"title":"Designing multi-epitope vaccine against human cytomegalovirus integrating pan-genome and reverse vaccinology pipelines","authors":"Rhitam Biswas ,&nbsp;Rayapadi G. Swetha ,&nbsp;Soumya Basu ,&nbsp;Aditi Roy ,&nbsp;Sudha Ramaiah ,&nbsp;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_C12 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":"2024-08-01","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}

{"title":"Current trends in development and manufacturing of higher-valent pneumococcal polysaccharide conjugate vaccine and its challenges","authors":"Shital S. Jain ,&nbsp;Vikas K. Singh ,&nbsp;Rajesh Kumar Kante ,&nbsp;Swapan Kumar Jana ,&nbsp;Rajendra H. Patil","doi":"10.1016/j.biologicals.2024.101784","DOIUrl":"10.1016/j.biologicals.2024.101784","url":null,"abstract":"<div><p>Pneumococcal conjugate vaccines (PCVs) have been developed to protect against pneumococcal diseases caused by the more than 100 serotypes of the bacterium <em>Streptococcus pneumoniae</em>. PCVs primarily prevent pneumococcal infections such as sepsis, bacteraemia, meningitis, otitis media, pneumonia, septicaemia, and sinusitis among infants, adults, elderly, and immunocompromised individuals<em>.</em> The current available PCVs only cover a limited number of serotypes, and there is an immense need for developing higher-valent PCVs that can protect against non-vaccine serotypes to overcome challenges like serotype replacement and antibiotic resistance. The main challenges for developing higher valent PCVs are the complexity of the manufacturing process comprising polysaccharide fermentation, purification, modification or sizing of multiple polysaccharides and conjugation between polysaccharides and carrier proteins, the stability of the conjugates, and the immunogenicity of the vaccine. Different manufacturing processes have been explored to produce higher valent PCVs using different serotypes of <em>S. pneumoniae</em> and conjugation with different carrier proteins. The global coverage of higher valent PCVs are still low, mainly due to the high cost and limited supply of the vaccine. This review focuses on the existing and emerging manufacturing processes and challenges associated with higher-valent pneumococcal PCV development.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":"87 ","pages":"Article 101784"},"PeriodicalIF":1.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141762843","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}

{"title":"From discovery to innovation in animal health: Maturing emerging technologies for industrial development","authors":"Johannes Charlier ,&nbsp;Laetitia Cicchelero ,&nbsp;Alexandra PM. Cloherty ,&nbsp;Emmanuel Hanon ,&nbsp;Matthias Hofer ,&nbsp;Filip Goossens ,&nbsp;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&amp;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}

{"title":"Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea","authors":"Su Kyoung Seong ,&nbsp;Young Hoon Kim ,&nbsp;Youngju Choi ,&nbsp;Hyun Jung Koh ,&nbsp;Seong Jae Kim ,&nbsp;Myoung Jun Kim ,&nbsp;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}