{"title":"Simple analytical tools for detection of impurities in biologics produced using the Sf-baculovirus platform","authors":"Maya Yovcheva","doi":"10.18609/cgti.2023.053","DOIUrl":"https://doi.org/10.18609/cgti.2023.053","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48800581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Designing viral vector clearance studies for CGT products according to ICH Q5A (R2): part 1","authors":"Tareq Jaber","doi":"10.18609/cgti.2023.067","DOIUrl":"https://doi.org/10.18609/cgti.2023.067","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46716769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"At the cutting edge of AAV capsid engineering","authors":"Eric D. Kelsic, A. Veres","doi":"10.18609/cgti.2023.066","DOIUrl":"https://doi.org/10.18609/cgti.2023.066","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43449904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Determination of physical viral vector titer in process development & QC for cell & gene therapy","authors":"Daniel Forssträm, John Chappell","doi":"10.18609/cgti.2023.060","DOIUrl":"https://doi.org/10.18609/cgti.2023.060","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43703444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Advancing AAV gene therapy development for the treatment of neurodegenerative diseases","authors":"Carina S Peritore","doi":"10.18609/cgti.2023.041","DOIUrl":"https://doi.org/10.18609/cgti.2023.041","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42055948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gene therapy can be used to permanently correct genetic disorders by delivering a transgene product into the nucleus of affected or alternative cells. One of the biggest challenges faced by the gene therapy bioanalytical sector is the lack of a true reference material for transgene products. As a result, in most assays, an alternative commercially available therapeutic (for example, an enzyme replacement therapy product) can be used as a surrogate for the transgene enzyme. This article discusses approaches taken in order to monitor the concentration of the expressed transgene product and any associated immunogenicity.
{"title":"Challenges of developing anti-drug antibody & concentration (PK or PD) assays for liposomal transgene enzymes on an automated immunoassay platform","authors":"John Chappell, Issa Jyamubandi","doi":"10.18609/cgti.2023.036","DOIUrl":"https://doi.org/10.18609/cgti.2023.036","url":null,"abstract":"Gene therapy can be used to permanently correct genetic disorders by delivering a transgene product into the nucleus of affected or alternative cells. One of the biggest challenges faced by the gene therapy bioanalytical sector is the lack of a true reference material for transgene products. As a result, in most assays, an alternative commercially available therapeutic (for example, an enzyme replacement therapy product) can be used as a surrogate for the transgene enzyme. This article discusses approaches taken in order to monitor the concentration of the expressed transgene product and any associated immunogenicity.","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42494565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"New directions and evolving challenges in the CAR-T cell therapy space","authors":"A. Hefni, D. Kuzan","doi":"10.18609/cgti.2023.027","DOIUrl":"https://doi.org/10.18609/cgti.2023.027","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44464231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Standardizing success: paving the way for streamlined viral vector manufacturing in gene therapy","authors":"R. Martín-Ibañez","doi":"10.18609/cgti.2023.056","DOIUrl":"https://doi.org/10.18609/cgti.2023.056","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45549275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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