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Simple analytical tools for detection of impurities in biologics produced using the Sf-baculovirus platform 用于检测使用Sf杆状病毒平台生产的生物制品中杂质的简单分析工具
Cell & gene therapy insights Pub Date : 2023-07-07 DOI: 10.18609/cgti.2023.053
Maya Yovcheva
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引用次数: 0
Designing viral vector clearance studies for CGT products according to ICH Q5A (R2): part 1 根据ICH Q5A (R2)设计CGT产品的病毒载体清除研究:第1部分
Cell & gene therapy insights Pub Date : 2023-07-07 DOI: 10.18609/cgti.2023.067
Tareq Jaber
{"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}
引用次数: 0
At the cutting edge of AAV capsid engineering 处于AAV衣壳工程的前沿
Cell & gene therapy insights Pub Date : 2023-07-07 DOI: 10.18609/cgti.2023.066
Eric D. Kelsic, A. Veres
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引用次数: 0
Determination of physical viral vector titer in process development & QC for cell & gene therapy 细胞和基因治疗过程开发和QC中物理病毒载体滴度的测定
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.060
Daniel Forssträm, John Chappell
{"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}
引用次数: 0
Advancing AAV gene therapy development for the treatment of neurodegenerative diseases 推进AAV基因治疗神经退行性疾病的进展
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.041
Carina S Peritore
{"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}
引用次数: 0
Sustainable plasmid DNA strategies, achieving streamlined secure supply to clinic & commercialization 可持续的质粒DNA策略，实现临床和商业化的流线型安全供应
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.058
Andrew R. Frazer, A. Weiss
{"title":"Sustainable plasmid DNA strategies, achieving streamlined secure supply to clinic & commercialization","authors":"Andrew R. Frazer, A. Weiss","doi":"10.18609/cgti.2023.058","DOIUrl":"https://doi.org/10.18609/cgti.2023.058","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":"43846427","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}
引用次数: 0
Setting up a one-stop shop: bringing viral vector manufacturing in-house 建立一站式商店：将病毒载体制造引入内部
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.049
D. Steele
{"title":"Setting up a one-stop shop: bringing viral vector manufacturing in-house","authors":"D. Steele","doi":"10.18609/cgti.2023.049","DOIUrl":"https://doi.org/10.18609/cgti.2023.049","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":"49044602","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}
引用次数: 0
Challenges of developing anti-drug antibody & concentration (PK or PD) assays for liposomal transgene enzymes on an automated immunoassay platform 在自动化免疫分析平台上开发抗药物抗体和脂质体转基因酶浓度(PK或PD)分析的挑战
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.036
John Chappell, Issa Jyamubandi
{"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}
引用次数: 0
New directions and evolving challenges in the CAR-T cell therapy space CAR-T细胞治疗领域的新方向和不断演变的挑战
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.027
A. Hefni, D. Kuzan
{"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}
引用次数: 0
Standardizing success: paving the way for streamlined viral vector manufacturing in gene therapy 标准化的成功:为基因治疗中简化的病毒载体制造铺平道路
Cell & gene therapy insights Pub Date : 2023-04-10 DOI: 10.18609/cgti.2023.056
R. Martín-Ibañez
{"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}
引用次数: 0
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