ArticleThe AAPS journal2024
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development.
Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
What it found
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The trial behind it
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.
- Impact of Extraction Recovery and Matrix Effect on qPCR-based Biodistribution Analysis in Gene Therapy: Strategies for Mitigation.The AAPS journal · 2026Article
- Development and Validation of a Viability RT-qPCR Assay for Detecting Infectious Spring Viraemia of Carp Virus (SVCV).Journal of fish diseases · 2026Article
- PIWI-Interacting RNAs in Cardiovascular Disease: From Epigenetic Regulators to Clinical Biomarkers and Therapeutic Targets.Reviews in cardiovascular medicine · 2026Review
- Understanding the qPCR Standard Curve: From Assay Validation to Absolute Quantification and Variance PCR.International journal of molecular sciences · 2026Review
- Development of a digital analysis system for a novel 3D culture-based colony formation to detect malignantly transformed cells in human cell-based therapeutic products.Regenerative therapy · 2026Article
- Perspectives on PCR-Based Cellular Kinetics and Biodistribution Analysis for Emerging Adoptive Cell Therapies.The AAPS journal · 2026Review
- Evaluation of Plasma-Derived Cell-Free RNA isolation methods using PCR-Based quantification.Molecular biology reports · 2026Article
- New insight into RNA biomarkers in neuropathic pain: a clinician-neuroscientist roadmap to translational testing and treatment monitoring a clinical review.Frontiers in pain research (Lausanne, Switzerland) · 2026Review
- Preclinical evaluation of AL-001, a gene therapy for wet age-related macular degeneration.Frontiers in genetics · 2026Article
- Evaluation of the Novel RITA MTBC Assay for Tuberculosis Detection: A Pilot Comparison with GeneXpert and BD MAX™.Pathogens (Basel, Switzerland) · 2025Article
- Analysis of qPCR Data: From PCR Efficiency to Absolute Target Quantity.International journal of molecular sciences · 2025Review
- Validation of a Göttingen Minipig Gene Therapy Biodistribution Assay for AVGN7 Using Droplet Digital Polymerase Chain Reaction.The AAPS journal · 2025Article
- Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR.The AAPS journal · 2025Article
- Method validation and assessment of the biodistribution and shedding for adenovirus vector-based vaccine using qPCR and dPCR.Molecular therapy. Methods & clinical development · 2025Article
- Polymerase Chain Reaction Chips for Biomarker Discovery and Validation in Drug Development.Micromachines · 2025Review
- Comparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle-Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK Studies.The AAPS journal · 2025Article
- Comprehensive performance evaluation of a high-throughput automated system for pathogen nucleic acid detection in clinical settings.Frontiers in microbiology · 2025Article
- Methods for telomere length measurement: an update on current technologies and emerging approaches.Frontiers in molecular biosciences · 2025Review
- Generic Reporter Sets for Colorimetric Multiplex dPCR Demonstrated with 6-Plex SNP Quantification Panels.International journal of molecular sciences · 2024Article
- Review
Corrections and comments
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Authors and funding
37 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
Identifiers
38316745What OpenQuestion holds
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.