ReviewJournal of biotechnology2002
Applications of quantitative PCR in the biosafety and genetic stability assessment of biotechnology products.
Review in Journal of biotechnology, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
20 citing papers in PubMed.
- Establishment of a scalable engineered cell-line platform for direct, GMP-grade production of eVLP vectors enabling streamlined generation of gene-edited CAR-T/NK cells.Frontiers in immunology · 2026Article
- Extracellular viral microRNAs as biomarkers of virus infection in human cells.Molecular therapy. Nucleic acids · 2025Article
- Article
- Comparison of 2 sampling methods for molecular detection of bacteria or fungi from feline hair and scale specimens.Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc · 2023Article
- Biodistribution and immunity of adenovirus 5/35 and modified vaccinia Ankara vector vaccines against human immunodeficiency virus 1 clade C.Gene therapy · 2022Article
- Article
- Quantitative PCR methodology with a volume-based unit for the sophisticated cellular kinetic evaluation of chimeric antigen receptor T cells.Scientific reports · 2020Article
- Standardization of DNA Residual Quantification Method of Vero Cell Rabies Vaccine for Human Use.The open medicinal chemistry journal · 2017Article
- Development of molecular markers, based on chloroplast and ribosomal DNA regions, to discriminate three popular medicinal plant species, Cynanchum wilfordii, Cynanchum auriculatum, and Polygonum multiflorum.Molecular biology reports · 2016Article
- Cost-effective master cell bank validation of multiple clinical-grade human pluripotent stem cell lines from a single donor.Stem cells translational medicine · 2014Article
- Practical application of DNA markers for high-throughput authentication of Panax ginseng and Panax quinquefolius from commercial ginseng products.Journal of ginseng research · 2014Article
- Fragmentation of DNA affects the accuracy of the DNA quantitation by the commonly used methods.Biological procedures online · 2013Article
- Biodistribution and safety assessment of bladder cancer specific recombinant oncolytic adenovirus in subcutaneous xenografts tumor model in nude mice.Current gene therapy · 2012Article
- Production and validation of a good manufacturing practice grade human fibroblast line for supporting human embryonic stem cell derivation and culture.Stem cell research & therapy · 2012Article
- Article
- A quantitative PCR method to quantify ruminant DNA in porcine crude heparin.Analytical and bioanalytical chemistry · 2011Article
- Development and application of a real-time PCR method for pharmacokinetic and biodistribution studies of recombinant adenovirus.Molecular biotechnology · 2009Article
- Statistical tools for transgene copy number estimation based on real-time PCR.BMC bioinformatics · 2007Article
- Gene transfer vector biodistribution: pivotal safety studies in clinical gene therapy development.Gene therapy · 2004Review
- Semiquantitative detection by real-time PCR of Aspergillus fumigatus in bronchoalveolar lavage fluids and tissue biopsy specimens from patients with invasive aspergillosis.Journal of clinical microbiology · 2003Article
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
High throughput screening, increased accuracy and the coupling of real-time quantitative PCR (Q-PCR) to robotic set-up systems are beginning to revolutionise biotechnology. Applications of Q-PCR within biotechnology are discussed with particular emphasis on the following areas of biosafety and genetic stability testing: (a) determination of the biodistribution of gene therapy vectors in animals; (b) quantification of the residual DNA in final product therapeutics; (c) detection of viral and bacterial nucleic acid in contaminated cell banks and final products; (d) quantification of the level of virus removal in process validation viral clearance studies; (e) specific detection of retroviral RT activity in vaccines with high sensitivity; and (f) transgene copy number determination for monitoring genetic stability during production. Methods employed for Q-PCR assay validation as required in ICH Topic Q2A Validation of Analytical Methods: Definitions and Terminology (1st June 1995) are also reviewed.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.