Supplemental guidance on testing for replication-competent retrovirus in retroviral vector-based gene therapy products and during follow-up of patients in clinical trials using retroviral vectors.

Abstract

Human Gene TherapyVol. 12, No. 3 Guidance for Industry, US Dept of Health and Human Services, Food and Drug AdminSupplemental Guidance on Testing for Replication-Competent Retrovirus in Retroviral Vector-Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral VectorsPublished Online:6 Jul 2004https://doi.org/10.1089/10430340150218440AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited byCurrent strategies employed in the manipulation of gene expression for clinical purposes18 November 2022 | Journal of Translational Medicine, Vol. 20, No. 1A Sensitive Liquid Chromatography-Mass Spectrometry Method for Determination of Toosendanin in Rat Plasma and its Application to Pharmacokinetic Study21 December 2021 | Journal of Chromatographic Science, Vol. 60, No. 5Sensitive detection of integrated and free transcripts in chimeric antigen receptor T-cell manufactured cell products using droplet digital polymerase chain reactionCytotherapy, Vol. 23, No. 5Chimeric Antigen Receptor T Cell Therapy Management and Safety: A Practical Tool From a Multidisciplinary Team Perspective11 March 2021 | Frontiers in Oncology, Vol. 11Selecting a Cell Engineering Methodology During Cell Therapy Product Development20 May 2021 | Cell Transplantation, Vol. 30Production of CAR-T Cells for Clinical ApplicationsQuality Control and Nonclinical Research on CAR-T Cell Products: General Principles and Key IssuesEngineering, Vol. 5, No. 1Reducing Ex Vivo Culture Improves the Antileukemic Activity of Chimeric Antigen Receptor (CAR) T Cells4 September 2018 | Cancer Immunology Research, Vol. 6, No. 9Detection of Replication Competent Lentivirus Using a qPCR Assay for VSV-GMolecular Therapy - Methods & Clinical Development, Vol. 8Retroviral and Lentiviral Safety Analysis of Gene-Modified T Cell Products and Infused HIV and Oncology PatientsMolecular Therapy, Vol. 26, No. 1Viral Vectors for Gene Transfer: Current Status of Gene Therapeutics19 November 2009Repeat Administration of Proteins to the Eye With a Single Intraocular Injection of an Adenovirus VectorMolecular Therapy, Vol. 16, No. 8A replication competent lentivirus (RCL) assay for equine infectious anaemia virus (EIAV)-based lentiviral vectors6 October 2005 | Gene Therapy, Vol. 13, No. 3Lentiviral Vectors1 November 2005An improved method for detection of replication-competent retrovirus in retrovirus vector productsBiologicals, Vol. 32, No. 3Detection of replication-competent adenoviruses spiked into recombinant adenovirus vector products by infectivity PCRMolecular Therapy, Vol. 8, No. 6 Volume 12Issue 3Feb 2001 To cite this article:Supplemental Guidance on Testing for Replication-Competent Retrovirus in Retroviral Vector-Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors.Human Gene Therapy.Feb 2001.315-320.http://doi.org/10.1089/10430340150218440Published in Volume: 12 Issue 3: July 6, 2004PDF download