A Digestion-free Method for Quantification of Residual Host Cell DNA in rAAV Gene Therapy Products
Open Access
- 17 May 2019
- journal article
- research article
- Published by Elsevier BV in Molecular Therapy - Methods & Clinical Development
- Vol. 13, 526-531
- https://doi.org/10.1016/j.omtm.2019.05.005
Abstract
No abstract availableKeywords
This publication has 20 references indexed in Scilit:
- A direct qPCR method for residual DNA quantification in monoclonal antibody drugs produced in CHO cellsJournal of Pharmaceutical and Biomedical Analysis, 2015
- Systematic Comparison and Validation of Quantitative Real-Time PCR Methods for the Quantitation of Adeno-Associated Viral ProductsHuman Gene Therapy Methods, 2015
- AAV-Mediated Gene Therapy for Research and Therapeutic PurposesAnnual Review of Virology, 2014
- Direct real-time quantitative PCR for measurement of host-cell residual DNA in therapeutic proteinsJournal of Pharmaceutical and Biomedical Analysis, 2014
- Development and qualification of a high sensitivity, high throughput Q-PCR assay for quantitation of residual host cell DNA in purification process intermediate and drug substance samplesJournal of Pharmaceutical and Biomedical Analysis, 2014
- Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk AssessmentBiomedicines, 2014
- Residual DNA analysis in biologics development: Review of measurement and quantitation technologies and future directionsBiotechnology & Bioengineering, 2011
- Development of a quantitative PCR assay for residual mouse DNA and comparison of four sample purification methods for DNA isolationJournal of Pharmaceutical and Biomedical Analysis, 2011
- Gene Therapy Using Adeno-Associated Virus VectorsClinical Microbiology Reviews, 2008
- Preparation of Bacterial DNA Template by Boiling and Effect of Immunoglobulin G as an Inhibitor in Real-Time PCR for Serum Samples from Patients with BrucellosisClinical and Vaccine Immunology, 2008