Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues.
ABCB5
HSSATA17 sequence
biodistribution
cell therapy
mesenchymal stromal cells
quantitative polymerase chain reaction
spike recovery
tissue matrix effects
Journal
Cells
ISSN: 2073-4409
Titre abrégé: Cells
Pays: Switzerland
ID NLM: 101600052
Informations de publication
Date de publication:
05 Jul 2023
05 Jul 2023
Historique:
received:
25
05
2023
revised:
23
06
2023
accepted:
04
07
2023
medline:
17
7
2023
pubmed:
14
7
2023
entrez:
14
7
2023
Statut:
epublish
Résumé
Quantitative polymerase chain reaction (qPCR) has emerged as an important bioanalytical method for assessing the pharmacokinetics of human-cell-based medicinal products after xenotransplantation into immunodeficient mice. A particular challenge in bioanalytical qPCR studies is that the different tissues of the host organism can affect amplification efficiency and amplicon detection to varying degrees, and ignoring these matrix effects can easily cause a significant underestimation of the true number of target cells in a sample. Here, we describe the development and drug regulatory-compliant validation of a TaqMan
Identifiants
pubmed: 37443822
pii: cells12131788
doi: 10.3390/cells12131788
pmc: PMC10340683
pii:
doi:
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIA NIH HHS
ID : 1P01AG071463
Pays : United States
Organisme : NEI NIH HHS
ID : R24 EY028767
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY025794
Pays : United States
Organisme : NEI NIH HHS
ID : R01EY025794
Pays : United States
Organisme : NIA NIH HHS
ID : P01 AG071463
Pays : United States
Organisme : NEI NIH HHS
ID : R24EY028767
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL161087
Pays : United States
Références
Clin Chem. 2009 Apr;55(4):611-22
pubmed: 19246619
Clin Exp Metastasis. 2002;19(7):571-82
pubmed: 12498386
Appl Environ Microbiol. 1998 Oct;64(10):3748-53
pubmed: 9758794
Int J Mol Sci. 2019 Jul 23;20(14):
pubmed: 31340593
Mol Ther Methods Clin Dev. 2020 Jun 01;18:176-188
pubmed: 32637449
Mol Cell Probes. 2004 Feb;18(1):45-50
pubmed: 15036369
BMC Res Notes. 2008 Aug 28;1:70
pubmed: 18755023
J Clin Microbiol. 2001 Feb;39(2):485-93
pubmed: 11158094
Mol Ther Methods Clin Dev. 2020 Nov 17;20:152-168
pubmed: 33473355
Biochem Biophys Res Commun. 2000 May 19;271(3):726-30
pubmed: 10814530
Stem Cells Transl Med. 2018 Jan;7(1):78-86
pubmed: 29210198
Bioanalysis. 2022 Nov;14(21):1391-1405
pubmed: 36621859
Stem Cells Int. 2019 May 2;2019:5419501
pubmed: 31191676
J Virol Methods. 2013 May;189(2):311-6
pubmed: 23470543
AAPS J. 2022 Feb 22;24(2):36
pubmed: 35194700
Cytotherapy. 2017 Mar;19(3):384-394
pubmed: 28089755
Sci Rep. 2020 Aug 13;10(1):13684
pubmed: 32792506
FEBS J. 2011 Feb;278(3):427-41
pubmed: 21182594
Bioanalysis. 2022 Jun;14(12):853-863
pubmed: 35703321
BMC Biotechnol. 2011 Dec 16;11:124
pubmed: 22176647
Appl Spectrosc Rev. 2018;53(2-4):360-375
pubmed: 29563664
Environ Sci Technol. 2021 Aug 3;55(15):10210-10223
pubmed: 34286966
Mol Ther Methods Clin Dev. 2019 May 17;14:1-15
pubmed: 31236426
Bioanalysis. 2021 Mar;13(6):415-463
pubmed: 33533276
Bioanalysis. 2021 Jan;13(2):115-128
pubmed: 33356555
Br J Cancer. 2002 Nov 18;87(11):1328-35
pubmed: 12439725
PLoS One. 2015 Jan 30;10(1):e0115960
pubmed: 25635817
Am J Transl Res. 2022 Apr 15;14(4):2147-2161
pubmed: 35559383
Chem Rev. 2022 Jun 8;122(11):10266-10318
pubmed: 35549242
Regen Ther. 2021 Jul 12;18:202-216
pubmed: 34307798
Trends Biotechnol. 2019 Jul;37(7):761-774
pubmed: 30654913
Stem Cell Res Ther. 2019 Jun 25;10(1):187
pubmed: 31238982
Int J Mol Sci. 2018 Aug 29;19(9):
pubmed: 30158455
J Clin Med. 2021 Jun 29;10(13):
pubmed: 34210026
Sci Rep. 2018 Feb 21;8(1):3410
pubmed: 29467420
Cytotherapy. 2017 Sep;19(9):1060-1069
pubmed: 28734679
Nat Biotechnol. 2014 Aug;32(8):721-3
pubmed: 25093890
Muscle Nerve. 1998 Aug;21(8):1064-7
pubmed: 9655125
Nat Rev Mol Cell Biol. 2005 Sep;6(9):677-88
pubmed: 16103871
Cytotherapy. 2019 May;21(5):546-560
pubmed: 30878384
Anal Bioanal Chem. 2020 Apr;412(9):2009-2023
pubmed: 32052066
Regen Ther. 2020 Nov 17;15:251-257
pubmed: 33426226
Int J Mol Sci. 2022 Dec 21;24(1):
pubmed: 36613507
Bioanalysis. 2022 Aug;14(16):1085-1093
pubmed: 36125042
J Forensic Sci. 2009 Sep;54(5):1001-7
pubmed: 19686392
Front Microbiol. 2014 May 07;5:195
pubmed: 24847315
Stem Cell Res Ther. 2020 Nov 16;11(1):482
pubmed: 33198791
Bioanalysis. 2021 Dec;13(23):1723-1729
pubmed: 34708666
Cell Transplant. 2015;24(8):1639-52
pubmed: 24849807
Int J Mol Sci. 2022 Dec 31;24(1):
pubmed: 36614138
J Forensic Sci. 2010 Jan;55(1):25-33
pubmed: 20015162
AAPS J. 2023 Feb 17;25(2):26
pubmed: 36806998
J Biol Chem. 2003 Nov 21;278(47):47156-65
pubmed: 12960149
Anal Bioanal Chem. 2018 Apr;410(10):2569-2583
pubmed: 29504082