{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T22:03:58Z","timestamp":1792015438998,"version":"4.4.0"},"reference-count":34,"publisher":"Elsevier BV","issue":"5","license":[{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["jpharmsci.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Pharmaceutical Sciences"],"published-print":{"date-parts":[[2024,5]]},"DOI":"10.1016\/j.xphs.2024.02.028","type":"journal-article","created":{"date-parts":[[2024,3,4]],"date-time":"2024-03-04T17:09:04Z","timestamp":1709572144000},"page":"1168-1176","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"title":["Application of Multivariate Data Analysis on Historical Recombinant Adenovirus Zoster Vaccine Production Data for Upstream Process Improvements"],"prefix":"10.1016","volume":"113","author":[{"given":"Jianqi","family":"Nie","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"He","family":"Ren","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yang","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ye","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhonghu","family":"Bai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"10255","key":"10.1016\/j.xphs.2024.02.028_bib0001","doi-asserted-by":"crossref","first-page":"887","DOI":"10.1016\/S0140-6736(20)31866-3","article-title":"Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1\/2 studies from Russia","volume":"396","author":"Logunov","year":"2020","journal-title":"Lancet"},{"issue":"3","key":"10.1016\/j.xphs.2024.02.028_bib0002","doi-asserted-by":"crossref","first-page":"e324","DOI":"10.1016\/S2214-109X(16)30367-9","article-title":"Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial","volume":"5","author":"Li","year":"2017","journal-title":"Lancet Glob Health"},{"issue":"13","key":"10.1016\/j.xphs.2024.02.028_bib0003","doi-asserted-by":"crossref","first-page":"2036","DOI":"10.1016\/j.vaccine.2022.02.024","article-title":"The efficient development of a novel recombinant adenovirus zoster vaccine perfusion production process","volume":"40","author":"Nie","year":"2022","journal-title":"Vaccine"},{"issue":"8","key":"10.1016\/j.xphs.2024.02.028_bib0004","doi-asserted-by":"crossref","DOI":"10.1002\/biot.201800716","article-title":"Scalable manufacturing of human mesenchymal stromal cells in the vertical-wheel bioreactor system: an experimental and economic approach","volume":"14","author":"de Sousa Pinto","year":"2019","journal-title":"Biotechnol J"},{"issue":"4","key":"10.1016\/j.xphs.2024.02.028_bib0005","doi-asserted-by":"crossref","first-page":"1328","DOI":"10.1016\/j.biotechadv.2018.04.011","article-title":"Perfusion mammalian cell culture for recombinant protein manufacturing - a critical review","volume":"36","author":"Bielser","year":"2018","journal-title":"Biotechnol Adv"},{"key":"10.1016\/j.xphs.2024.02.028_bib0006","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/j.bej.2016.02.003","article-title":"Characterization and comparison of ATF and TFF in stirred bioreactors for continuous mammalian cell culture processes","volume":"110","author":"Karst","year":"2016","journal-title":"Biochem Eng J"},{"issue":"47","key":"10.1016\/j.xphs.2024.02.028_bib0007","doi-asserted-by":"crossref","first-page":"7011","DOI":"10.1016\/j.vaccine.2019.06.005","article-title":"Influenza A virus production in a single-use orbital shaken bioreactor with ATF or TFF perfusion systems","volume":"37","author":"Coronel","year":"2019","journal-title":"Vaccine"},{"issue":"10","key":"10.1016\/j.xphs.2024.02.028_bib0008","doi-asserted-by":"crossref","first-page":"3040","DOI":"10.1002\/bit.27470","article-title":"Virus harvesting in perfusion culture: Choosing the right type of hollow fiber membrane","volume":"117","author":"Nikolay","year":"2020","journal-title":"Biotechnol Bioeng"},{"issue":"6","key":"10.1016\/j.xphs.2024.02.028_bib0009","doi-asserted-by":"crossref","first-page":"1291","DOI":"10.1002\/btpr.1953","article-title":"Understanding and modeling alternating tangential flow filtration for perfusion cell culture","volume":"30","author":"Kelly","year":"2014","journal-title":"Biotechnol Prog"},{"issue":"4","key":"10.1016\/j.xphs.2024.02.028_bib0010","doi-asserted-by":"crossref","first-page":"967","DOI":"10.1002\/btpr.1922","article-title":"Guidance for performing multivariate data analysis of bioprocessing data: pitfalls and recommendations","volume":"30","author":"Rathore","year":"2014","journal-title":"Biotechnol Prog"},{"issue":"3","key":"10.1016\/j.xphs.2024.02.028_bib0011","doi-asserted-by":"crossref","first-page":"720","DOI":"10.1021\/bp0704384","article-title":"Rathore AS Application of multivariate data analysis for identification and successful resolution of a root cause for a bioprocessing application","volume":"24","author":"Kirdar","year":"2008","journal-title":"Biotechnol Prog"},{"key":"10.1016\/j.xphs.2024.02.028_bib0012","doi-asserted-by":"crossref","DOI":"10.1016\/j.biotechadv.2020.107637","article-title":"Multivariate data analysis in cell gene therapy manufacturing","volume":"45","author":"Emerson","year":"2020","journal-title":"Biotechnol Adv"},{"issue":"1","key":"10.1016\/j.xphs.2024.02.028_bib0013","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1021\/bp060377u","article-title":"Application of multivariate analysis toward biotech processes: case study of a cell-culture unit operation","volume":"23","author":"Kirdar","year":"2007","journal-title":"Biotechnol Prog"},{"issue":"3","key":"10.1016\/j.xphs.2024.02.028_bib0014","doi-asserted-by":"crossref","first-page":"858","DOI":"10.1021\/bp034237l","article-title":"High-titer adenovirus vector production in 293S cell perfusion culture","volume":"20","author":"Cortin","year":"2004","journal-title":"Biotechnol Prog"},{"issue":"7-8","key":"10.1016\/j.xphs.2024.02.028_bib0015","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1016\/S0734-9750(02)00030-7","article-title":"Production of adenovirus vector for gene therapy","volume":"20","author":"Nadeau","year":"2003","journal-title":"Biotechnol Adv"},{"issue":"23","key":"10.1016\/j.xphs.2024.02.028_bib0016","doi-asserted-by":"crossref","first-page":"2187","DOI":"10.1056\/NEJMoa2101544","article-title":"Safety and efficacy of single-dose Ad26.COV2.S vaccine against Covid-19","volume":"384","author":"Sadoff","year":"2021","journal-title":"N Engl J Med"},{"issue":"1","key":"10.1016\/j.xphs.2024.02.028_bib0017","doi-asserted-by":"crossref","first-page":"4081","DOI":"10.1038\/s41467-020-17972-1","article-title":"A single dose of an adenovirus-vectored vaccine provides protection against SARS-CoV-2 challenge","volume":"11","author":"Wu","year":"2020","journal-title":"Nature Commun"},{"issue":"2","key":"10.1016\/j.xphs.2024.02.028_bib0018","doi-asserted-by":"crossref","first-page":"300","DOI":"10.1016\/j.vaccine.2011.10.095","article-title":"Process optimization and scale-up for production of rabies vaccine live adenovirus vector (AdRG1.3)","volume":"30","author":"Shen","year":"2012","journal-title":"Vaccine"},{"issue":"29","key":"10.1016\/j.xphs.2024.02.028_bib0019","doi-asserted-by":"crossref","first-page":"3381","DOI":"10.1016\/j.vaccine.2016.04.090","article-title":"Optimization and scale-up of cell culture and purification processes for production of an adenovirus-vectored tuberculosis vaccine candidate","volume":"34","author":"Shen","year":"2016","journal-title":"Vaccine"},{"issue":"7","key":"10.1016\/j.xphs.2024.02.028_bib0020","doi-asserted-by":"crossref","first-page":"619","DOI":"10.1080\/14760584.2018.1495565","article-title":"Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention","volume":"17","author":"Lecrenier","year":"2018","journal-title":"Expert Rev Vaccines"},{"issue":"3","key":"10.1016\/j.xphs.2024.02.028_bib0021","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1007\/s00253-005-1980-8","article-title":"Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals","volume":"68","author":"Butler","year":"2005","journal-title":"Appl Microbiol Biotechnol"},{"issue":"7","key":"10.1016\/j.xphs.2024.02.028_bib0022","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1080\/07388551.2021.1998821","article-title":"Perfusion culture of Chinese hamster ovary cells for bioprocessing applications","volume":"42","author":"MacDonald","year":"2022","journal-title":"Crit Rev Biotechnol"},{"issue":"2","key":"10.1016\/j.xphs.2024.02.028_bib0023","doi-asserted-by":"crossref","first-page":"180","DOI":"10.1016\/j.jbiotec.2007.03.020","article-title":"Process analytical technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control","volume":"132","author":"Gnoth","year":"2007","journal-title":"J Biotechnol"},{"issue":"3-4","key":"10.1016\/j.xphs.2024.02.028_bib0024","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1080\/10408340600969957","article-title":"Process analytical technology beyond real-time analyzers: the role of multivariate analysis","volume":"36","author":"Kourti","year":"2006","journal-title":"Crit Rev Anal Chem"},{"issue":"1","key":"10.1016\/j.xphs.2024.02.028_bib0025","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1002\/bit.22788","article-title":"Multivariate data analysis on historical IPV production data for better process understanding and future improvements","volume":"107","author":"Thomassen","year":"2010","journal-title":"Biotechnol Bioeng"},{"issue":"4","key":"10.1016\/j.xphs.2024.02.028_bib0026","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1080\/14712598.2018.1421169","article-title":"Maintaining consistent quality and clinical performance of biopharmaceuticals","volume":"18","author":"Lamanna","year":"2018","journal-title":"Expert Opin Biol Ther"},{"issue":"2","key":"10.1016\/j.xphs.2024.02.028_bib0027","doi-asserted-by":"crossref","DOI":"10.1002\/biot.201800137","article-title":"Larger pore size hollow fiber membranes as a solution to the product retention issue in filtration-based perfusion bioreactors","volume":"14","author":"Wang","year":"2019","journal-title":"Biotechnol J"},{"key":"10.1016\/j.xphs.2024.02.028_bib0028","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.jbiotec.2017.01.020","article-title":"Shear contributions to cell culture performance and product recovery in ATF and TFF perfusion systems","volume":"246","author":"Wang","year":"2017","journal-title":"J Biotechnol"},{"issue":"6","key":"10.1016\/j.xphs.2024.02.028_bib0029","doi-asserted-by":"crossref","first-page":"e2870","DOI":"10.1002\/btpr.2870","article-title":"Scale-down model qualification of ambr(R) 250 high-throughput mini-bioreactor system for two commercial-scale mAb processes","volume":"35","author":"Manahan","year":"2019","journal-title":"Biotechnol Prog"},{"key":"10.1016\/j.xphs.2024.02.028_bib0030","first-page":"55","article-title":"Bag bioreactor based on wave-induced motion: characteristics and applications","volume":"115","author":"Eibl","year":"2009","journal-title":"Adv Biochem Eng Biotechnol"},{"issue":"3","key":"10.1016\/j.xphs.2024.02.028_bib0031","doi-asserted-by":"crossref","first-page":"907","DOI":"10.1021\/acssuschemeng.5b01005","article-title":"Functionalization of flat sheet and hollow fiber microfiltration membranes for water applications","volume":"4","author":"Hernandez","year":"2016","journal-title":"ACS Sustain Chem Eng"},{"issue":"1","key":"10.1016\/j.xphs.2024.02.028_bib0032","doi-asserted-by":"crossref","first-page":"61","DOI":"10.1007\/BF00772196","article-title":"High-density culture of FM-3A cells using a bioreactor with an external tangential-flow filtration device","volume":"14","author":"Kawahara","year":"1994","journal-title":"Cytotechnology"},{"key":"10.1016\/j.xphs.2024.02.028_bib0033","series-title":"Bioreactors: Design, Operation and Novel Applications","author":"Mandenius","year":"2016"},{"issue":"11","key":"10.1016\/j.xphs.2024.02.028_bib0034","doi-asserted-by":"crossref","first-page":"1347","DOI":"10.1007\/s10529-022-03302-6","article-title":"Optimization of an adenovirus-vectored zoster vaccine production process with chemically defined medium and a perfusion system","volume":"44","author":"Nie","year":"2022","journal-title":"Biotechnol Lett"}],"container-title":["Journal of Pharmaceutical Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354924000844?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0022354924000844?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,4,15]],"date-time":"2024-04-15T08:17:52Z","timestamp":1713169072000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0022354924000844"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":34,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["S0022354924000844"],"URL":"https:\/\/doi.org\/10.1016\/j.xphs.2024.02.028","relation":{},"ISSN":["0022-3549"],"issn-type":[{"value":"0022-3549","type":"print"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Application of Multivariate Data Analysis on Historical Recombinant Adenovirus Zoster Vaccine Production Data for Upstream Process Improvements","name":"articletitle","label":"Article Title"},{"value":"Journal of Pharmaceutical Sciences","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xphs.2024.02.028","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}