Cell & gene therapy insights最新文献

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Simplifying lentiviral downstream processing with a novel affinity resin & robust analytical tools 一种新型亲和树脂简化慢病毒下游加工强大的分析工具
Cell & gene therapy insights Pub Date : 2023-03-02 DOI: 10.18609/cgti.2023.021
Chantelle Gaskin, Suzy Brown
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引用次数: 0
mRNA manufacturing and analytics: INFOGRAPHIC mRNA制造和分析:信息图
Cell & gene therapy insights Pub Date : 2023-03-02 DOI: 10.18609/cgti.2023.042
{"title":"mRNA manufacturing and analytics: INFOGRAPHIC","authors":"","doi":"10.18609/cgti.2023.042","DOIUrl":"https://doi.org/10.18609/cgti.2023.042","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47794986","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 in cryogenic storage containers for cell & gene therapy 细胞和基因治疗的低温储存容器面临的挑战
Cell & gene therapy insights Pub Date : 2023-03-02 DOI: 10.18609/cgti.2023.034
Sean R. Werner, A. Sargent
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引用次数: 0
Preclinical toolkit evolution for cancer vaccines & CAR-T cell therapy 癌症疫苗和CAR-T细胞治疗的临床前工具包进化
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.005
A. Snook
{"title":"Preclinical toolkit evolution for cancer vaccines & CAR-T cell therapy","authors":"A. Snook","doi":"10.18609/cgti.2023.005","DOIUrl":"https://doi.org/10.18609/cgti.2023.005","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41342138","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
Seizing the day: addressing the urgent need for standards development in regenerative medicine 只争朝夕:解决再生医学标准发展的迫切需要
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.033
R. Mcfarland
{"title":"Seizing the day: addressing the urgent need for standards development in regenerative medicine","authors":"R. Mcfarland","doi":"10.18609/cgti.2023.033","DOIUrl":"https://doi.org/10.18609/cgti.2023.033","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42512821","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
Corrigendum to: thinking ahead: developing biosynthetic blood to anticipate donor drought 未雨绸缪:开发生物合成血液以应对献血者短缺
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.007
Andrew Goldman, Shane Kilpatrick, Marinna Madrid, Zhong Ri Lim, Steve Oh, Taylor Rose, Lena Patel, Barbara Nelsen
{"title":"Corrigendum to: thinking ahead: developing biosynthetic blood to anticipate donor drought","authors":"Andrew Goldman, Shane Kilpatrick, Marinna Madrid, Zhong Ri Lim, Steve Oh, Taylor Rose, Lena Patel, Barbara Nelsen","doi":"10.18609/cgti.2023.007","DOIUrl":"https://doi.org/10.18609/cgti.2023.007","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135480991","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
Maximizing efficiency & flexibility in viral vector manufacturing scale-up 最大限度地提高病毒载体生产规模的效率和灵活性
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.025
Denis Kole, John Petrone, M. Bisschops, N. Hazi
{"title":"Maximizing efficiency & flexibility in viral vector manufacturing scale-up","authors":"Denis Kole, John Petrone, M. Bisschops, N. Hazi","doi":"10.18609/cgti.2023.025","DOIUrl":"https://doi.org/10.18609/cgti.2023.025","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41367510","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
Vaccines & beyond: a decade in mRNA delivery 疫苗及其他:mRNA传递的十年
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.008
Russell Johnson
{"title":"Vaccines & beyond: a decade in mRNA delivery","authors":"Russell Johnson","doi":"10.18609/cgti.2023.008","DOIUrl":"https://doi.org/10.18609/cgti.2023.008","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43053853","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
Advanced therapies, hospital exemptions & marketing authorizations: the UK’s emerging regulatory framework for point-of-care manufacture 先进疗法,医院豁免和营销授权:英国新兴的护理点制造监管框架
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.015
E. Bicudo, I. Brass
{"title":"Advanced therapies, hospital exemptions & marketing authorizations: the UK’s emerging regulatory framework for point-of-care manufacture","authors":"E. Bicudo, I. Brass","doi":"10.18609/cgti.2023.015","DOIUrl":"https://doi.org/10.18609/cgti.2023.015","url":null,"abstract":"Hospital-centred manufacture, which consists in producing therapies close to the patient, within a hospital or in a nearby unit, is becoming increasingly viable and necessary. There are at least two modalities of this kind of manufacture: in what we name bedside manufacture, therapy production relies on hospital infrastructure and facilities, products can have all sorts of shelf life, and a small number of hospitals is involved; in the emerging modality called point-of-care manufacture, there is great reliance on portable manufacturing devices taken to the hospital, products have short or very short shelf life, and a large number of hospitals may be involved. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed a new regulatory framework dedicated to point-of-care manufacture. A large range of products can be manufactured this way, including some Advanced Therapy Medicinal Products (ATMPs), which are medicines based on cells, genes or tissues. Bedside manufacture has been traditionally overseen via regulatory exemptions. In the European Union (EU), the manufacture of ATMPs in hospitals or for hospitals has been covered by the “Hospital Exemption”. In the UK, another exemption, known as the Specials scheme, has been used. Both exemptions are grounded on the specificities of hospitals and clinical needs. The MHRA’s current regulatory proposal introduces a new rationale in which point-of-care manufacture will be subject to a flexible and proportionate framework while following the regulatory pathway now valid for commercial products, including the conduct of clinical trials and the issuance of marketing authorisations. This brings about a market route that will coexist with the clinical route of exemptions. This article analyses the implications and uncertainties of the UK’s possible move from regulatory exemptions (bedside manufacture) to marketing authorizations (point-of-care manufacture) for hospital-produced ATMPs. It also sheds light on strategic issues triggered by the MHRA’s proposal.","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45988049","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: 1
Key considerations when translating a cell therapy product into the clinic 将细胞治疗产品转化为临床时的关键注意事项
Cell & gene therapy insights Pub Date : 2023-01-18 DOI: 10.18609/cgti.2023.011
Anthony Ting
{"title":"Key considerations when translating a cell therapy product into the clinic","authors":"Anthony Ting","doi":"10.18609/cgti.2023.011","DOIUrl":"https://doi.org/10.18609/cgti.2023.011","url":null,"abstract":"","PeriodicalId":72538,"journal":{"name":"Cell & gene therapy insights","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46329931","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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