Biologicals最新文献

{"title":"Advances in mRNA vaccine research in the field of quality control","authors":"Daomiao Huang ,&nbsp;Na Li ,&nbsp;Xin Dong","doi":"10.1016/j.biologicals.2024.101799","DOIUrl":"10.1016/j.biologicals.2024.101799","url":null,"abstract":"<div><div>In recent years, innovative research and development of mRNA vaccines have made remarkable achievements, especially in the context of pandemic infectious diseases such as the COVID-19 virus, and the need for rapid vaccine development has further fueled the rapid growth of this field. Nevertheless, there are still gaps in our understanding of the working mechanism of mRNA vaccines and their long-term safety, efficacy, and quality control. This article summarizes the development background and production process of mRNA vaccines, outlines existing reference guidelines, quality control projects, and testing methods at home and abroad, and also summarizes the difficulties and future prospects in research and development and quality control. It provides a reference for developing guidelines for mRNA vaccine production, quality control, and preclinical and clinical evaluation.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142586259","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":"Collaborative study on the cross-reactivity of two influenza B viral components in single radial immunodiffusion assay using quadrivalent influenza vaccines in Japan from 2015/16 to 2021–22 influenza season","authors":"Noriko Shimasaki ,&nbsp;Yuichi Harada ,&nbsp;Kazuya Nakamura ,&nbsp;Hitoshi Takahashi ,&nbsp;Kayoko Sato ,&nbsp;Tomoko Kuwahara ,&nbsp;Masaki Ochiai ,&nbsp;Hideki Hasegawa ,&nbsp;Shigeyuki Itamura","doi":"10.1016/j.biologicals.2024.101797","DOIUrl":"10.1016/j.biologicals.2024.101797","url":null,"abstract":"<div><div>A quadrivalent influenza vaccine (QIV) has been available in Japan since the 2015/2016 influenza season. Single radial immunodiffusion (SRID) assays are currently used worldwide to measure the hemagglutinin (HA) content of influenza vaccine components because they are simple, accurate, and the regulatory requirement, ensuring consistency in manufacture for the HA content. However, the cross-reactivity of antisera against the two lineages of the influenza B virus (IFVB) may cause inaccurate quantification of HA content in QIVs using the SRID assay. To examine cross-reactivity and develop an appropriate procedure for accurate measurement of vaccine potency, a collaborative study with four Japanese vaccine manufacturers was conducted to measure the HA contents of trivalent influenza vaccines (TIVs) and QIVs by SRID assay with a single and a mixture of reference antigens (refAgs) from each lineage of IFVB for seven influenza seasons from 2015/16 to 2021/22. The cross-reactivity of the two IFVB components in the SRID assay varied depending on the vaccine viruses. Our study demonstrated that it is useful to validate a suitable combination for each refAg and reference antiserum by selecting the combination showing similar HA contents between experimental TIV and QIV before lot release testing.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142554080","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":"Computational identification of monkeypox virus epitopes to generate a novel vaccine antigen against Mpox","authors":"Özge Dülek ,&nbsp;Gizem Mutlu ,&nbsp;Ecem Su Koçkaya ,&nbsp;Hüseyin Can ,&nbsp;Muhammet Karakavuk ,&nbsp;Aysu Değirmenci Döşkaya ,&nbsp;Adnan Yüksel Gürüz ,&nbsp;Mert Döşkaya ,&nbsp;Cemal Ün","doi":"10.1016/j.biologicals.2024.101798","DOIUrl":"10.1016/j.biologicals.2024.101798","url":null,"abstract":"<div><div>Monkeypox virus (MPXV) belonging to poxviridae family causes chronic viral disease in various mammals including human and monkeys. Conventional vaccines developed against smallpox of poxviridae, are not specific against Mpox. Also, they can cause various side effects after vaccination. In this study, we aimed to analyze the A17L, A28L, A37R, A43R, E8L, H3L, B6R, and M1R structural proteins of MPXV and identify epitopes in them which can be used to generate vaccine antigens. Among the proteins analyzed, the M1R protein was predicted to be more appropriate for use in vaccine research due to its high antigenicity value and other physicochemical features. Also, A17L, B6R and E8L had high antigenicity values. E8L protein was more conserved while the A37R, A43R, and B6R proteins had signal peptides. Although a total of eight B cell epitopes were predicted in all proteins analyzed, CNGETK epitope belonging to B6R protein had the highest antigenicity value (1.7083), as well as was non-allergenic, non-toxic, and soluble. Based on T cell epitope analyses performed on all proteins, fourteen MHC-I/II epitopes were predicted that are antigenic, non-allergenic and non-toxic, as well as soluble. Among them, MHC-I related-HEIYDRNVGF epitope in A28L protein had the highest antigenicity value (1.6650) and MHC-II related-IGNIKIVQIDIRDIK epitope in A37R protein had the highest antigenicity value (2.0280). In conclusion, eight structural proteins of MPXV were successfully analyzed and 22 important epitopes were identified that could serve as vaccine antigens or in serological studies to develop diagnostic tools.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142549080","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":"A vision for patient-centric specifications for biologicals","authors":"Philip Krause,&nbsp;Cristiana Campa,&nbsp;Andrew Chang,&nbsp;Shawn Novick,&nbsp;Barbara Rellahan,&nbsp;Tim Schofield,&nbsp;Dean Smith","doi":"10.1016/j.biologicals.2024.101796","DOIUrl":"10.1016/j.biologicals.2024.101796","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142431946","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":"Evaluation of the focus reduction neutralization and ELISA tests compared to the plaque reduction neutralization test for the detection of antibodies against measles virus","authors":"Somayeh Yaghoobizad ,&nbsp;Zahra Norouzbabaei ,&nbsp;Nazanin Zahra Shafiei Jandaghi ,&nbsp;Abbas Rahimi Foroushani ,&nbsp;Kaveh Sadeghi ,&nbsp;Shahrokh Izadi ,&nbsp;Ghazal Sadat Fatemi-Nasab ,&nbsp;Elaheh Heidari ,&nbsp;Vahid Salimi ,&nbsp;Talat Mokhtari-Azad","doi":"10.1016/j.biologicals.2024.101795","DOIUrl":"10.1016/j.biologicals.2024.101795","url":null,"abstract":"<div><div>Measles is an infectious febrile sickness caused by the measles virus (MeV). Despite an effective vaccine, regional elimination of measles remains a global priority and still faces challenges.</div><div>To estimate community protection against measles, sensitive tests are needed to identify measles-specific antibodies. The enzyme-linked immunosorbent assay (ELISA) is the standard test for assessing immunity but may fail to detect weak antibody responses in vaccinated populations. The plaque reduction neutralization test (PRNT), is the gold standard test for the assessment of protective antibody levels, however, it is not suitable for routine use. This study validated the focus reduction neutralization test (FRNT) as an alternative.</div><div>In eight assay runs, fifty serum samples were analyzed in triplicate using PRNT, FRNT, and ELISA. Data analysis revealed that 38 samples were positive by PRNT, 37 by FRNT, and 19 by ELISA. The results showed that ELISA was not sensitive enough to identify low levels of anti-measles antibodies and showed weak agreement with neutralization assays. In contrast, the two neutralization assays had a perfect correlation and similar sensitivity. FRNT appears to be a suitable alternative to PRNT for characterizing immunological responses and vaccination efficacy.</div><div>Our results highlight the necessity of validating negative and equivocal ELISA results through neutralization methods, during the elimination phases.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382539","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":"Assessment of the risks associated with the use of in vivo versus in vitro potency tests for vaccines","authors":"Timothy Schofield","doi":"10.1016/j.biologicals.2024.101794","DOIUrl":"10.1016/j.biologicals.2024.101794","url":null,"abstract":"<div><div>Animal (<em>in vivo</em>) potency tests have been utilized for over a century in support of vaccine development and for quality testing. This is a legacy of the best science at the time of their introduction. Advances in knowledge and technology, however, have provided opportunities to utilize more sensitive assays during development and replace legacy animal tests with <em>in vitro</em> alternatives. This coupled with initiatives such as replacement, reduction, and refinement (the 3-R's) and quality by design (QbD) have brought industry and regulators together in the introduction of advanced vaccine control strategies.</div><div>This article examines historical and current uses of animals in vaccines technical development and control, and their replacement with <em>in vitro</em> alternatives from a risk point of view. An overarching risk is that a vaccine tested with an alternative potency assay fails to protect its target recipient. This can be addressed from the perspective of the assay's association with the vaccine mechanism of action, and the rules used to introduce the vaccine into the patient population (e.g., specifications). Commonly understood concepts such as analytical precision play a role in risk evaluation based on its impact on the sensitivity of a test to detect meaningful product changes caused by variations in manufacture or over a vaccine's shelf life. This should be considered when evaluating solutions such as the reduction of multi-concentration (or dilution) <em>in vivo</em> assays to a single concentration test. While the use of animals in vaccine development will not go away all together, the paradigm must shift from <em>in vivo tests</em> to <em>in vivo models</em>. To help ensure success, principles and practices related to introduction of <em>in vitro</em> alternatives require global collaboration among industry, regulators, pharmacopeias, and supporting organizations.</div></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382538","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":"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":null,"pages":null},"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":null,"pages":null},"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":"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":null,"pages":null},"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":"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":null,"pages":null},"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}