Biosafety in Handling Gene Transfer Vectors

Scott Swindle1

1 Occupational Medicine and Research Safety, The University of Alabama at Birmingham, Birmingham
Publication Name:  Current Protocols in Human Genetics
Unit Number:  Unit 12.1
DOI:  10.1002/cphg.54
Online Posting Date:  January, 2018
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Abstract

This unit is devoted to safety issues that must be considered when generating and working with the most common vectors under development for human gene therapy today. © 2018 by John Wiley & Sons, Inc.

Keywords: gene transfer; vectors; biosafety

     
 
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Table of Contents

  • Introduction
  • Background
  • Running A BL‐2 Lab
  • Specific Vectors
  • CRISPR/CAS9‐Based Genome Editing
  • Getting a Useful Vector into Clinical Trials
  • Obtaining Biosafety Committee Approval
  • Further Reading
  • Acknowledgements
  • Literature Cited
  • Figures
  • Tables
     
 
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Materials

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Figures

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Literature Cited

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Internet Resources
   https://www.cdc.gov/biosafety/publications/bmbl5/
  Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th edition, from the Centers for Disease Control (CDC) Office of Health Safety (OHS) and the NIH.
   https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm
  FDA Center for Biologics Evaluation and Research (CBER) home page.
   https://osp.od.nih.gov/
  The NIH Office of Science Policy.
   https://osp.od.nih.gov/wp‐content/uploads/NIH_Guidelines.html#_APPENDIX_B._CLASSIFICATION
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  https://osp.od.nih.gov/wp‐content/uploads/NIH_Guidelines.html#_Toc446948489
  APPENDIX M of the April 2002 NIH Recombinant DNA Guidelines, consisting of a series of screening questions concerning potential vectors and their application to human gene therapy.
   http://www.wiley.com/legacy/wileychi/genmed/clinical/
  Resource for gene therapy clinical trials worldwide provided by the Journal of gene Medicine.
   https://www.orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/Pages/DesignRequirementsManual2016.aspx
  NIH Design Requirements Manual 2016 (revised 4/17/2‐17).
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  Biosafety Manual from the University of Pennsylvania.
   https://ehs.princeton.edu/laboratory‐research/biological‐safety/biosafety‐manual
  Biosafety Manual from Stanford University.
   https://ehs.stanford.edu/manual/biosafety‐manual
  Biosafety Manual from Princeton University.
   https://ehs.princeton.edu/laboratory‐research/biological‐safety/biosafety‐manual
  National Gene Vector Biorepository (NGVB).
   https://ngvbcc.org
  http://www.ggact.org
   http://www.ggact.org
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