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Autor
Adamowicz, Wendy 1 Azadeh, Mitra 1 Birch, Donald 1 Chalfant, Melanie 1 Colletti, Kelly 1 Dholakiya, Sanjay L 1 Diaz, Manisha 1 Doddareddy, Rajitha 1 Durham, Jennifer 1 Guelman, Sebastian 1 Gullick, Bryan 1 Hays, Amanda 1 Jani, Niketa 1 Johansson, Oskar 1 John, Kaarthik 1 Koenig, Kaylyn 1 Kubista, Mikael 1 Liu, Hsing-Yin 1 Lockman, Timothy 1 Mercier, Jonathan 1
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Pracoviště
Altasciences Preclinical Seattle LLC Everett... 1 Asher Biotherapeutics Inc South San Francisc... 1 Beam Therapeutics Cambridge Massachusetts USA 1 BioAgilytix Laboratories Boston Massachusett... 1 BioAgilytix Laboratories Durham North Caroli... 1 BioMarin Pharmaceutical Inc Novato Californi... 1 Bristol Myers Squibb Princeton New Jersey USA 1 Charles River Labs Reno Nevada USA 1 Charles River Labs Senneville Québec Canada 1 Eli Lilly and Company Indianapolis Indiana USA 1 Eurofins Viracor BioPharma Services Inc Lene... 1 Flowmetric Life Sciences Inc Spring House Pe... 1 GSK Collegeville Pennsylvania USA 1 Genentech Inc South San Francisco California... 1 Institute of Biotechnology Czech Academy of ... 1 Janssen Research and Development LLC Spring ... 1 KCAS Bioanalytical and Biomarker Services Sh... 1 Labcorp Drug Development Greenfield Indiana USA 1 Merck and Co Inc Rahway New Jersey USA 1 PPD Clinical Research Thermo Fisher Scientif... 1
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NLK
Medline Complete (EBSCOhost)
od 2010-01-01 do Před 1 rokem
PubMed
38316745
DOI
10.1208/s12248-023-00880-9
Knihovny.cz E-zdroje
The emerging use of qPCR and dPCR in regulated bioanalysis and absence of regulatory guidance on assay validations for these platforms has resulted in discussions on lack of harmonization on assay design and appropriate acceptance criteria for these assays. Both qPCR and dPCR are extensively used to answer bioanalytical questions for novel modalities such as cell and gene therapies. Following cross-industry conversations on the lack of information and guidelines for these assays, an American Association of Pharmaceutical Scientists working group was formed to address these gaps by bringing together 37 industry experts from 24 organizations to discuss best practices to gain a better understanding in the industry and facilitate filings to health authorities. Herein, this team provides considerations on assay design, development, and validation testing for PCR assays that are used in cell and gene therapies including (1) biodistribution; (2) transgene expression; (3) viral shedding; (4) and persistence or cellular kinetics of cell therapies.
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