Gene Therapy

Gene Therapy - Problems and Challenges ,[object Object],[object Object],[object Object],Helapet Aseptic Study Day 2008

Gene Therapy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Gene Therapy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Gene Therapy Vectors ,[object Object],Therapeutic gene (Transgene) Therapeutic protein Vector for efficient gene delivery Transcription Translation

Types of Gene Therapy Vectors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Gene Therapy Strategies ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2001

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Retrovirus vector

Regulations governing the handling of gene therapy vectors ,[object Object],[object Object],[object Object],[object Object]

Genetic Modification ,[object Object],[object Object]

Regulations governing the handling of gene therapy viral vectors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Additional Regulations that apply to Gene Therapy Clinical Trials ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Containment Levels for GMOs Containment Measures Required Isolatable Lab Suite Microbiological Safety Cabinet Gloves Protective Clothing Class 1 Level 1 NO NO NO YES Requires first use of premises notification to HSE Class 2 Level 2 NO Risk Assessment R/A R/A YES Minimum requirement for any human blood or clinical samples. Requires HSE notification Class 3 Level 3 YES YES YES YES + Footwear Requires HSE notification Class 4 Level 4 YES YES YES YES Complete change of clothing and footwear on entry and exit Requires HSE notification

Guidelines on Handling GMOs in Pharmacy ,[object Object],[object Object],[object Object],[object Object]

APPENDIX 6 - GENE THERAPY ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Facilities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Clean room suite designed to provide protection to the cleanroom

Aseptic Manipulation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Decontamination ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Accidental Exposure

SOPs needed ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Risk Assessment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

What will the Future bring? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Additional Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Additional Information ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Gene Therapy

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Gene Therapy