Biologicals最新文献

{"title":"Enhanced productivity and stability of PRV in recombinant ST-Tret1 cells","authors":"Yue Xu ,&nbsp;Xi Bao ,&nbsp;Li Chen ,&nbsp;Tenghan Zhuang ,&nbsp;Yang Xu ,&nbsp;Lei Feng","doi":"10.1016/j.biologicals.2023.101692","DOIUrl":"10.1016/j.biologicals.2023.101692","url":null,"abstract":"<div><p><span>Productivity and stability of Pseudorabies virus<span><span> (PRV) are critical for the manufacture and storage of live attenuated pseudorabies vaccine. </span>Trehalose<span> is commonly used as a cryoprotectant to stabilize organisms during freezing and lyophilization. Trehalose transporter 1 (Tret1), derived from </span></span></span><em>Polypedilum vanderplanki</em><span><span>, can deliver trehalose with a reversible transporting direction. In this study, we demonstrated that productivity and stability of PRV proliferated in recombinant ST cells with stable expression of Tret1 were enhanced. As a result, a five-fold increase of intracellular trehalose amount was observed, and the significant increase of progeny </span>viral titer was achieved in recombinant cells with the addition of 20 mM trehalose. Particularly, after storage for 8 weeks at 20 °C, the loss of viral titer was 0.8 and 1.7 lgTCID</span>₅₀<span><span>/mL lower than the control group with or without the addition of trehalose. Additionally, the freeze-thaw resistance at −20 °C and −70 °C of PRV was significantly enhanced. Furthermore, according to standard international protocols, a series of tests, including karyotype analysis, </span>tumorigenicity, and the ability of proliferation PRV, were conducted. Our results demonstrated that the recombinant ST cell with Tret1 is a promising cell substrate and has a high potential for producing more stable PRV for the live attenuated vaccine.</span></p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10585590","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":"On-column virus inactivation by solvent/detergent treatment for a recombinant biological product","authors":"Daniel Polasek ,&nbsp;Andreas Flicker ,&nbsp;Christian Fiedler ,&nbsp;Maria R. Farcet ,&nbsp;Martin Purtscher ,&nbsp;Thomas R. Kreil","doi":"10.1016/j.biologicals.2023.101693","DOIUrl":"10.1016/j.biologicals.2023.101693","url":null,"abstract":"<div><p>Each process step in the manufacture of biological products requires expensive resources and reduces total process productivity. Since downstream processing of biologicals is the main cost driver, process intensification is a persistent topic during the entire product life cycle. We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount of S/D reagents. Comparison of key process parameters demonstrated equivalent process performance. To assess the viral clearance capacity of the novel approach, XMuLV was spiked as model virus to the chromatographic load and all resulting fractions were analyzed by TCID₅₀ and RT-qPCR. Data indicates the inactivation capability of on-column virus inactivation even at 10% of the nominal S/D concentration, although the mechanism of viral clearance needs further investigation.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10240814","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":"Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals","authors":"Arifa S. Khan ,&nbsp;Laurent Mallet ,&nbsp;Johannes Blümel ,&nbsp;Jean-Pol Cassart ,&nbsp;Ivana Knezevic ,&nbsp;Siemon H.S. Ng ,&nbsp;Michael Wall ,&nbsp;Miia Jakava-Viljanen ,&nbsp;Carine Logvinoff ,&nbsp;Ana Goios ,&nbsp;Pieter Neels","doi":"10.1016/j.biologicals.2023.101696","DOIUrl":"10.1016/j.biologicals.2023.101696","url":null,"abstract":"<div><p>Next-generation sequencing (NGS) has been proven to address some of the limitations of the current testing methods for adventitious virus detection in biologics. The International Alliance for Biological Standardization (IABS), the U.S. Food and Drug Administration (FDA), and the European Directorate for the Quality of Medicines and Healthcare (EDQM) co-organized the “3rd Conference on Next-generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals”, which was held on September 27–28, 2022, in Rockville, Maryland, U.S.A. The meeting gathered international representatives from regulatory and public health authorities and other government agencies, industry, contract research organizations, and academia to present the current status of NGS applications and the progress on NGS standardization and validation for detection of viral adventitious agents in biologics, including human and animal vaccines, gene therapies, and biotherapeutics. Current regulatory expectations were discussed for developing a scientific consensus regarding using NGS for detection of adventitious viruses. Although there are ongoing improvements in the NGS workflow, the development of reference materials for facilitating method qualification and validation support the current use of NGS for adventitious virus detection.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10522920/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10228794","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":"CDC20 is a potential target gene to inhibit the tumorigenesis of MDCK cells","authors":"Zhenbin Liu ,&nbsp;Mengyuan Pei ,&nbsp;Geng Liu ,&nbsp;Zhenyu Qiu ,&nbsp;Siya Wang ,&nbsp;Zilin Qiao ,&nbsp;Jiamin Wang ,&nbsp;Dongwu Jin ,&nbsp;Jiayou Zhang ,&nbsp;Kai Duan ,&nbsp;Xuanxuan Nian ,&nbsp;Zhongren Ma ,&nbsp;Xiaoming Yang","doi":"10.1016/j.biologicals.2023.101697","DOIUrl":"10.1016/j.biologicals.2023.101697","url":null,"abstract":"<div><p>MDCK is currently the main cell line used for influenza vaccine production in culture. Previous studies have reported that MDCK cells possess tumorigenic ability in nude mice. Although complete cell lysis can be ensured during vaccine production, host cell DNA released after cell lysis may still pose a risk for tumorigenesis. Greater caution is needed in the production of human vaccines; therefore, the use of gene editing to establish cells incapable of forming tumors may significantly improve the safety of influenza vaccines. Knowledge regarding the genes and molecular mechanisms that affect the tumorigenic ability of MDCK cells is crucial; however, our understanding remains superficial. Through monoclonal cell screening, we previously obtained a cell line, CL23, that possesses significantly reduced cell proliferation, migration, and invasion abilities, and tumor-bearing experiments in nude mice showed the absence of tumorigenic cells. With a view to exploring tumorigenesis-related genes in MDCK cells, DIA proteomics was used to compare the differences in protein expression between wild-type (M60) and non-tumorigenic (CL23) cells. Differentially expressed proteins were verified at the mRNA level by RT-qPCR, and a number of genes involved in cell tumorigenesis were preliminarily screened. Immunoblotting further confirmed that related protein expression was significantly reduced in non-tumorigenic cells. Inhibition of CDC20 expression by RNAi significantly reduced the proliferation and migration of MDCK cells and increased the proliferation of the influenza virus; therefore, CDC20 was preliminarily determined to be an effective target gene for the inhibition of cell tumorigenicity. These results contribute to a more comprehensive understanding of the mechanism underlying cell tumorigenesis and provide a basis for the establishment of target gene screening in genetically engineered non-tumorigenic MDCK cell lines.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10236013","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":"3Rs implementation in veterinary vaccine batch-release testing: Current state-of-the-art and future opportunities. A webinar and workshop report","authors":"Laura Viviani ,&nbsp;Elisabeth Balks ,&nbsp;Sonja Beken ,&nbsp;Anna-Maria Brady ,&nbsp;Rick Clayton ,&nbsp;Florence Cliquet ,&nbsp;Liys Desmayanti ,&nbsp;Silvia Fragoeiro ,&nbsp;Terrie Jo Hamtak ,&nbsp;David John ,&nbsp;Carmen Jungbaëck ,&nbsp;M. Kalaivani ,&nbsp;Imke Kross ,&nbsp;Catherine Lang ,&nbsp;Ni Made Ria Isriyanthi ,&nbsp;Laurent Mallet ,&nbsp;Catherine Milne ,&nbsp;Michelle Rubbrecht ,&nbsp;Botond Siklódi ,&nbsp;Brajesh Singh ,&nbsp;Joris Vandeputte","doi":"10.1016/j.biologicals.2023.101695","DOIUrl":"10.1016/j.biologicals.2023.101695","url":null,"abstract":"<div><p>Regulatory authorities require veterinary batch-release testing to confirm vaccine potency and safety, but these tests have traditionally relied on large numbers of laboratory animals. Advances in vaccine research and development offer increasing opportunities to replace <em>in vivo</em> testing, and some stakeholders have made significant progress in incorporating 3Rs elements in quality control strategies. A three-part event series entitled “3Rs Implementation in Veterinary Vaccine Batch-Release Testing: Current state-of-the-art and future opportunities” was jointly organized by the Animal-Free Safety Assessment Collaboration, HealthforAnimals, and the International Alliance of Biological Standardization. Two webinars and a workshop aimed to outline the state-of-the-art non-animal approaches for veterinary batch-release testing. The events included information on the state of the deletion of obsolete safety testing and the current initiatives implemented by European, North American, and Asian-Pacific stakeholders on 3Rs implementation and regulatory acceptance. The events contributed to a better understanding of the barriers to 3Rs implementation. Participants highlighted the need for open communication, continued collaboration between stakeholders, and international harmonization of regulatory requirements to help accelerate acceptance. Despite the challenges, the countries represented at this three-part event have shared their commitments to advancing the acceptance of alternative methods.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10240813","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)00042-8","DOIUrl":"https://doi.org/10.1016/S1045-1056(23)00042-8","url":null,"abstract":"","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49776152","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":"Future of TABST and LABST in the Indian Pharmacopoeia Monographs A Humane Society International/India Workshop Report","authors":"Brinda Poojary ,&nbsp;Laura Viviani ,&nbsp;Alokparna Sengupta ,&nbsp;M. Kalaivani ,&nbsp;Sh Rajesh Verma ,&nbsp;Vijay Teng ,&nbsp;Vijay Makhija ,&nbsp;Ram Prakash ,&nbsp;Nitin Bhatia ,&nbsp;S.N. Singh ,&nbsp;Lukas Bruckner ,&nbsp;Marlies Halder ,&nbsp;Jeroen Vree","doi":"10.1016/j.biologicals.2023.101665","DOIUrl":"10.1016/j.biologicals.2023.101665","url":null,"abstract":"<div><p>Humane Society International India (HSI India) organized and facilitated a workshop on the ‘Future of Target Animal Batch Safety Test (TABST) and Laboratory Animal Batch Safety Test (LABST) in the Indian Pharmacopoeia (IP) Monographs’. The workshop hosted key Indian regulators from the Indian Pharmacopoeia Commission (IPC) and the Central Drugs Standard Control Organization (CDSCO), industry representatives from the Indian Federation of Animal Health Companies (INFAH), Asian Animal Health Association (AAHA), and international experts representing the European Directorate for the Quality of Medicines (EDQM), the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), and multinational veterinary products manufacturers. The workshop was organized to encourage a bidirectional flow of information and to discuss the deletion of TABST and LABST from the veterinary vaccine monographs in the IP. This workshop was built from the symposium held by Humane Society International on the ‘Global Harmonization of Vaccine Testing Requirements’ held in 2019. This report details the outcomes of the workshop with proposed activities to be taken up as part of the next steps for the elimination or waiving of these tests.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10239797","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":"Stability of lyophilized Meningococcal A conjugate vaccine, (MenAfriVac™) at elevated temperatures to support controlled temperature chain (CTC) claim","authors":"Sunil Gairola,&nbsp;Prashant Bonde,&nbsp;Pankaj Sharma,&nbsp;Sameer kale,&nbsp;Sunil Goel,&nbsp;Suresh Jadhav","doi":"10.1016/j.biologicals.2023.101698","DOIUrl":"10.1016/j.biologicals.2023.101698","url":null,"abstract":"<div><p><span><span>Meningococcal A Conjugate Vaccine (MenAfriVac) is the world’s first Monovalent Conjugate Vaccine against </span>Neisseria Meningitidis </span>serogroup A which has obtained Controlled Temperature Chain (CTC) label claim of “stable upto 40°C for 4 days prior to reconstitution” developed by Serum Institute of India Pvt. Ltd. Pune, India and the vaccine was granted permission from World health Organization. This paper elucidates and talks about the layout of various studies performed to characterize the product to declare as CTC at the time when the knowledge and mechanism to describe CTC was not fully known which in term helped to design the CTC guidelines.</p><p>Product stability was assessed using clinical, consistency and regular lots released by NRA. The critical stability indicating parameters like free polysaccharide, molecular size distribution along with Potency and safety tests were carried out to support the product stability making sure it also qualifies for Vaccine Vial Monitor label claim of VVM30. An additional in use stability (reconstitution) was also performed. All studies indicated that the product remains stable at real time as well as elevated temperatures and well within the specifications approved by NRA and formed the strong basis for CTC claim which is now recommended by WHO.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10236003","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":"Tumorigenesis mechanism and application strategy of the MDCK cell line: A systematic review","authors":"Di Yang ,&nbsp;Lingwei Huang ,&nbsp;Jiamin Wang ,&nbsp;Huihao Wu ,&nbsp;Zhenbin Liu ,&nbsp;Ayimuguli Abudureyimu ,&nbsp;Zilin Qiao","doi":"10.1016/j.biologicals.2023.101699","DOIUrl":"10.1016/j.biologicals.2023.101699","url":null,"abstract":"<div><p><span><span><span>Influenza is an acute respiratory infectious disease<span> caused by influenza virus that seriously endangers people's health. Influenza vaccination is the most effective means to prevent influenza </span></span>virus infection and its serious complications. </span>MDCK cells<span><span> are considered to be superior to chicken embryos for the production of influenza vaccines, but the </span>tumorigenicity of cells is a concern over the theoretical possibility of the risk of adverse events. The theoretical risks need to be adequately addressed if public confidence in programs of immunization are to be maintained. In this paper, studies of the tumorigenic potential of cell lines, with MDCK cells as an example, published since 2010 are reviewed. The mechanism of tumorigenicity of MDCK cells is discussed with reference to </span></span>cell heterogeneity<span> and epithelial to mesenchymal transition (EMT). Understanding the mechanism of the acquisition of a tumorigenic phenotype by MDCK cells might assist in estimating potential risks associated with using tumorigenic cell substrates for vaccine production.</span></p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10238005","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":"Epidemiology-driven approaches to surveillance in HPAI-vaccinated poultry flocks aiming to demonstrate freedom from circulating HPAIV","authors":"Timm Harder ,&nbsp;Sjaak de Wit ,&nbsp;Jose L. Gonzales ,&nbsp;Jeremy H.P. Ho ,&nbsp;Paolo Mulatti ,&nbsp;Teguh Y. Prajitno ,&nbsp;Arjan Stegeman","doi":"10.1016/j.biologicals.2023.101694","DOIUrl":"10.1016/j.biologicals.2023.101694","url":null,"abstract":"<div><p>Incursion pressure of high pathogenicity avian influenza viruses (HPAIV) by secondary spread among poultry holdings and/or from infected migratory wild bird populations increases worldwide. Vaccination as an additional layer of protection of poultry holdings using appropriately matched vaccines aims at reducing clinical sequelae of HPAIV infection, disrupting HPAIV transmission, curtailing economic losses and animal welfare problems and cutting exposure risks of zoonotic HPAIV at the avian-human interface. Products derived from HPAIV-vaccinated poultry should not impose any risk of virus spread or exposure. Vaccination can be carried out with zero-tolerance for infection in vaccinated herds and must then be flanked by appropriate surveillance which requires tailoring at several levels: (i) Controlling appropriate vaccination coverage and adequate population immunity in individual flocks and across vaccinated populations; (ii) assessing HPAI-infection trends in unvaccinated and vaccinated parts of the poultry population to provide early detection of new/re-emerged HPAIV outbreaks; and (iii) proving absence of HPAIV circulation in vaccinated flocks ideally by real time-monitoring. Surveillance strategies, i.e. selecting targets, tools and random sample sizes, must be accommodated to the specific epidemiologic and socio-economic background. Methodological approaches and practical examples from three countries or territories applying AI vaccination under different circumstances are reviewed here.</p></div>","PeriodicalId":55369,"journal":{"name":"Biologicals","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10239300","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}