Biologicals最新文献

{"title":"An ELISA system for tetanus toxoid potency tests: An alternative to lethal challenge","authors":"Masaaki Iwaki ,&nbsp;Tsuyoshi Kenri ,&nbsp;Mitsutoshi Senoh","doi":"10.1016/j.biologicals.2023.101681","DOIUrl":"10.1016/j.biologicals.2023.101681","url":null,"abstract":"<div><p><span>For a long time, a widely used method for tetanus toxoid (Ttd) potency has been the challenge test, in which animals are immunized and then challenged with </span>tetanus toxin in lethal or non-lethal way. In the context of animal welfare, an alternative is desired because the method causes unsustainable distress to animals.</p><p>We aimed to replace the system for describing test results, in which scores are assigned to symptoms exhibited by challenged animals, with scores assigned to antibody ELISA titers in immunized mouse sera. The potency values and confidence intervals calculated by the absorbance score system were equivalent to those calculated by the symptom score system. We also attempted to utilize the raw ELISA absorbance instead of the assigned absorbance score and obtained similar results. ELISA may serve as an alternative to the lethal challenge for Ttd potency tests, not only in Japan but also in other countries in which mouse challenge tests are employed.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9703910","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":"The development and establishment of a heat inactivated preparation of Mycobacterium tuberculosis (H37Rv) as the first international standard for nucleic acid amplification techniques","authors":"Mei M. Ho,&nbsp;Belinda Dagg,&nbsp;Sheila Govind,&nbsp;Jason Hockley,&nbsp;the Collaborative Study Group","doi":"10.1016/j.biologicals.2023.101667","DOIUrl":"10.1016/j.biologicals.2023.101667","url":null,"abstract":"<div><p>A need to develop an inactivated <em>Mycobacterium tuberculosis</em> (<em>Mtb</em>) preparation, to be used as a DNA standard, as an important and urgent requirement for Tuberculosis (TB) diagnostics standardization was identified in 2018. A candidate material was generated using a heat inactivated culture of <em>Mtb</em> strain H37Rv. A lyophilised preparation was evaluated for its suitability as an International Standard for molecular detection of <em>Mtb</em> DNA in an international collaborative study. Together with the use of quantitative PCR assays and rapid diagnostic tests, this candidate standard was demonstrated to be fit-for-purpose. Based on the results from this collaborative study, it is proposed this lyophilised heat inactivated <em>Mtb</em> preparation (NIBSC code: 20/152) to be established by the World Health Organization Expert Committee on Biological Standardization, as the First WHO International Standard for <em>Mycobacterium tuberculosis</em> (H37Rv) for nucleic acid amplification techniques with an assigned unitage of 6.3 log₁₀ or 2 × 10⁶ International Units per vial.</p><p>The intended uses of this IS are for calibration of secondary or in-house reference preparations used in the assays for the molecular detection of <em>Mtb</em> DNA. It may also be used for assay validation and monitoring the performance in terms of limit of detection of rapid diagnostic tests.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9649377","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":"Canine parvovirus type 2 vaccines in Brazil: Viral load in commercial vaccine vials and phylogenetic analysis of the vaccine viruses","authors":"Michele Machado Lencina ,&nbsp;Uwe Truyen ,&nbsp;Weslei de Oliveira Santana ,&nbsp;Diéssy Kipper ,&nbsp;Ana Paula Longaray Delamare ,&nbsp;Suelen Paesi ,&nbsp;Vagner Ricardo Lunge ,&nbsp;André Felipe Streck","doi":"10.1016/j.biologicals.2023.101676","DOIUrl":"10.1016/j.biologicals.2023.101676","url":null,"abstract":"<div><p><span><span>Canine parvovirus<span> type 2 (CPV-2) is the etiological agent of a highly contagious and frequently fatal disease in dogs. Live attenuated vaccines (LAV) are recommended to prevent and control this disease. Commercial vaccines are typically produced with CPV-2 strains adapted to cell culture and usually non-pathogenic. The present study aimed to determine the viral load<span> of CPV-2 vaccines commercially available in Brazil and to characterize the vaccine virus by DNA analysis of its </span></span></span>capsid<span> gene. The results demonstrated that all vaccine strains presented high homology of the VP2 gene and they were all closely related to the original CPV-2 strains. However, vaccine strains presented several differences in comparison with field strains currently circulating in Brazil. Seventy-one vials contained viral loads ranging from 7.4E3 to 4.9E10 DNA copies/ml. Nine vials did not contain any detectable CPV-2 DNA. In conclusion, there are </span></span>genetic and antigenic differences among CPV-2 vaccines and field strains. Additionally, some vaccines have been commercialized with low titers of CPV-2. It is important to improve the quality of the vaccines to prevent or reduce the spread of CPV-2 in Brazil.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9702877","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":"Development and validation of a spectrophotometric method for quantification of residual cyclodextrin (DIMEB; Heptakis) in pertussis antigens","authors":"Bharat Shinde ,&nbsp;Dadasaheb Patil ,&nbsp;Vinod Nandre ,&nbsp;Manish Gautam ,&nbsp;Pooja Doshi ,&nbsp;Sunil Gairola","doi":"10.1016/j.biologicals.2023.101663","DOIUrl":"10.1016/j.biologicals.2023.101663","url":null,"abstract":"<div><p><span><span>Methylated derivatives of cyclodextrins<span><span> such as DIMEB (2,6-di-O-methyl)-β-cyclodextrin or Heptakis is commonly used as culture medium modifier in manufacturing of pertussis<span><span> antigens for promoting the growth of bacteria. We report here development and validation of a spectrophotometric method for estimation of DIMEB in different product matrices of pertussis vaccine antigens i.e. Filamentous </span>haemagglutinin (FHA), </span></span>Pertactin<span> (PRN) and Pertussis toxin (PT). The detection is based on characteristic reaction of hydrolyzed sugars derivatives from DIMEB i.e., </span></span></span>furfural derivatives with anthrone reagent to form colored complexes which could be quantified at 625 nm. Method showed excellent linearity with correlation coefficient (R</span>²) &gt; 0.995 over the concentration of 5.0–80.0 μg. LOD and LOQ of 1.47 μg and 4.46 μg respectively was reported. The overall precision (repeatability and intermediate precision) showed % RSD for DIMEB content &lt;10.0% for all the matrices. % Recoveries for DIMEB after three different spike levels (low, middle and high) were within 90%–113%. The method was successfully applied for determination of residual DIMEB in different product matrices of FHA, PRN and PT protein antigens. This can be used to monitor residual DIMEB levels during manufacturing of acellular pertussis antigens.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9231911","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(23)00010-6","DOIUrl":"https://doi.org/10.1016/S1045-1056(23)00010-6","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49812341","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":"Comparability of biosimilar romiplostim with originator: Protein characterization, animal pharmacodynamics and pharmacokinetics","authors":"Anna N. Arefeva ,&nbsp;Igor E. Makarenko ,&nbsp;Valeria B. Saparova ,&nbsp;Dzhina D. Karal-ogli ,&nbsp;Alina N. Afanaseva ,&nbsp;Artem R. Dorotenko ,&nbsp;Anna V. Kalatanova ,&nbsp;Denis V. Kurkin ,&nbsp;Alexandr L. Khokhlov ,&nbsp;Roman V. Drai","doi":"10.1016/j.biologicals.2023.101666","DOIUrl":"10.1016/j.biologicals.2023.101666","url":null,"abstract":"<div><p>The results of preclinical studies<span> of romiplostim analogue GP40141 are presented.</span></p><p><span>The effect of a cell proliferation<span><span>, phosphorylation of the TPO receptor and </span>JAK2 phosphorylation were studied in the presence of romiplostim and in the presence of GP40141 in a cell line of mice (</span></span><span><em>Mus musculus</em></span><span>) lymphoblasts<span> with stable expression of human TPO receptor 32D-hTPOR clone 63. Binding to the TPO receptor and to the neonatal Fc receptor (FcRn) was examined for both romiplostim and the developed analogue.</span></span></p><p>In Sprague-Dawley rats, the dynamics of platelet count<span> after the administration of romiplostim or GP40141 were determined. The pharmacokinetics<span> of romiplostim and GP40141, as well as the dynamics of platelet count, were studied in cynomolgus monkeys. The serum concentrations of romiplostim were determined using a modified colorimetric enzyme-linked immunosorbent assay (ELISA).</span></span></p><p>The data obtained allow us to assert the similarity of the biological action of Nplate® and GP40141.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9244745","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":"Quantitation of free cyanide using ion exchange chromatography in Neisseria meningitidis serogroups A, C, W, Y and X conjugates used in vaccine manufacture","authors":"Saurav Ghosh,&nbsp;Ashishkumar Gulhane,&nbsp;Pankaj Sharma,&nbsp;Sameer Kale,&nbsp;Vivek Kangralkar,&nbsp;Rakesh Pawar,&nbsp;Sunil Kumar Goel,&nbsp;Asha D. Mallya,&nbsp;Rajeev M. Dhere","doi":"10.1016/j.biologicals.2023.101664","DOIUrl":"10.1016/j.biologicals.2023.101664","url":null,"abstract":"<div><p><span><span>Polysaccharide<span> vaccines essentially used in the prevention of bacterial infections are known to be good immunogens when conjugated to an immunogenic protein using various cyanylating agents. Analysis of residual cyanide in polysaccharide conjugate vaccines is an ardent task due to the complexity of the sample matrices and the lack of suitable methods. We report a selective </span></span>ion chromatography<span> method with electrochemical detection<span><span> using IonPac AS7 column for estimation of residual cyanide in meningococcal serogroups A, C, W, Y and X bulk </span>conjugates in presence of other interfering ions. Gold electrode and Ag/AgCl reference electrode ensures sensitivity and reproducibility of cyanide quantitation. The calibration curve of the method is linear having r</span></span></span>² ≥0.990 over the concentration range 1.45 ng/mL to 93.10 ng/mL. The recovery of cyanide in bulk conjugates ranged between 96.0% and 108.9%. The limits of detection and quantitation were 0.50 ng/mL and 1.45 ng/mL which corresponds to 0.31 ng/μg and 0.91 ng/μg of polysaccharide respectively. The method validation and feasibility study were performed using Men W and Men X bulk conjugates respectively with in house residual cyanide specification due to unavailability of pharmacopeia guidelines. The method is reproducible and can accurately quantify residual cyanide in purified meningococcal bulk conjugates.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9237978","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":"Historical evaluation of the in vivo adventitious virus test and its potential for replacement with next generation sequencing (NGS)","authors":"Paul W. Barone ,&nbsp;Flora J. Keumurian ,&nbsp;Caleb Neufeld ,&nbsp;Andrea Koenigsberg ,&nbsp;Robert Kiss ,&nbsp;James Leung ,&nbsp;Michael Wiebe ,&nbsp;Rima Ait-Belkacem ,&nbsp;Chakameh Azimpour Tabrizi ,&nbsp;Cristina Barbirato ,&nbsp;Pascale Beurdeley ,&nbsp;Audrey Brussel ,&nbsp;Jean-Pol Cassart ,&nbsp;Colette Cote ,&nbsp;Noémie Deneyer ,&nbsp;Veera Dheenadhayalan ,&nbsp;Leyla Diaz ,&nbsp;Angela Geiselhoeringer ,&nbsp;Maria M. Gilleece ,&nbsp;Jakob Goldmann ,&nbsp;Stacy L. Springs","doi":"10.1016/j.biologicals.2022.11.003","DOIUrl":"10.1016/j.biologicals.2022.11.003","url":null,"abstract":"<div><p>The Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) collected historical data from 20 biopharmaceutical industry members on their experience with the <em>in vivo</em> adventitious virus test, the <em>in vitro</em> virus test, and the use of next generation sequencing (NGS) for viral safety. Over the past 20 years, only three positive <em>in vivo</em> adventitious virus test results were reported, and all were also detected in another concurrent assay. In more than three cases, data collected as a part of this study also found that the <em>in vivo</em> adventitious virus test had given a negative result for a sample that was later found to contain virus. Additionally, the <em>in vivo</em> adventitious virus test had experienced at least 21 false positives and had to be repeated an additional 21 times all while using more than 84,000 animals. These data support the consideration and need for alternative broad spectrum viral detection tests that are faster, more sensitive, more accurate, more specific, and more humane. NGS is one technology that may meet this need. Eighty one percent of survey respondents are either already actively using or exploring the use of NGS for viral safety. The risks and challenges of replacing <em>in vivo</em> adventitious virus testing with NGS are discussed. It is proposed to update the overall virus safety program for new biopharmaceutical products by replacing <em>in vivo</em> adventitious virus testing approaches with modern methodologies, such as NGS, that maintain or even improve the final safety of the product.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9606455","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":"IABS/DCVMN webinar on next generation sequencing","authors":"Arifa S. Khan ,&nbsp;Sebastiaan Theuns ,&nbsp;Laurent Mallet ,&nbsp;Gwenael Cirefice ,&nbsp;Ravneet Bhuller ,&nbsp;Ana Goios ,&nbsp;Rajinder Suri ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2022.12.001","DOIUrl":"10.1016/j.biologicals.2022.12.001","url":null,"abstract":"<div><p>Next Generation Sequencing (NGS) is a new technology that could overcome some of the limitations of the current viral testing methods for demonstrating the absence of adventitious agents in biologics. This report is for the webinar that was organized by the International Alliance for Biological Standardization (IABS) and the Developing Countries Vaccine Manufacturers Network (DCVMN), held on July 20, 2022, as an introduction to the technical and bioinformatics concepts of NGS and to some of the strengths and limitations of using the technology for those working in vaccine production or development. The current state of scientific knowledge and readiness of NGS to replace or supplement the current viral tests was further discussed in the 3rd Conference on NGS for Adventitious Virus Detection in Biologics for Humans and Animals that was held in Rockville, Maryland, USA, on September 27–28, 2022.</p><p>The application of NGS to supplement or replace current <em>in vivo</em> and <em>in vitro</em> assays in adventitious virus testing during vaccine production is promising; however, assay performance (sensitivity, specificity, and reproducibility) needs to be demonstrated, which may include laboratory and bioinformatics work. Efforts from regulatory authorities, industry, and researchers are ongoing to facilitate validation and establishment of NGS as a new method for virus detection.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9230871","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":"Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Responses from a survey of vaccines and biological therapeutics manufacturers","authors":"Elliot Lilley ,&nbsp;Emmanuelle Coppens ,&nbsp;Pradip Das ,&nbsp;Francis Galaway ,&nbsp;Richard Isbrucker ,&nbsp;Sarah Sheridan ,&nbsp;Paul Stickings ,&nbsp;Anthony Holmes","doi":"10.1016/j.biologicals.2022.11.002","DOIUrl":"10.1016/j.biologicals.2022.11.002","url":null,"abstract":"<div><p>The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) has been tasked by the World Health Organization (WHO) to review the extent to which animal-based testing methods are described in their manuals, guidelines and recommendations for vaccines and biotherapeutics. The aim is to identify and recommend where updates to these documents can lead to an increased and more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction and Refinement of animal tests) in the quality control and batch release testing requirements for vaccines and biotherapeutics. Developing recommendations that are widely applicable by both the manufacturers and national regulatory authorities for vaccines and biologicals globally requires a detailed understanding of how different organisations view the opportunities and barriers to better integration of the 3Rs. To facilitate this, we developed and distributed a survey aimed at vaccine and biotherapeutics manufacturers in July 2021. In this paper, we present the key findings from this survey and how these will help inform the recommendations for wider integration of 3Rs approaches by WHO in their guidance documents applicable to the quality control and batch testing of vaccines and biotherapeutics.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10109345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9329185","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}