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Gene Therapy

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fondas vakalis
fondas vakalis

Gene therapy involves introducing genetic material into human cells to treat diseases. It aims to cure diseases by adding extra genes or replacing faulty genes. There are still many challenges to gene therapy, including developing safe and effective viral and non-viral vectors to deliver genes, avoiding unintended effects, and establishing regulations for clinical trials and production. As the field continues to advance, dedicated facilities and standardized procedures will be important to ensure patient safety.

Gesundheit & MedizinTechnologie
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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]
PTQA April 2008
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]

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