Gene Therapy
Within preclinical but also clinical studies JSW Life Sciences can provide essential support regarding safety, efficacy and regulatory issues.
The abundance of the virus as well as the desired gene product in target and non-target organs represents a prevailing safety criterion in gene therapy.
Quality assurance measures and adequate control studies are essential for the generation of a master cell bank, the seed stock and the final product.
The well conceived administration to adequate test animals and in later phases to man is essential for the success of a gene therapy approach.
JSW Life Sciences offers Gene Therapy Services in the complete process of drug development:
- Biodistribution studies
- Wild-type contamination studies
- Quantitative detection of gene product
- In vivo administration
Our validated protocols allow quantitative evaluations and fulfill ICH and FDA guidelines.
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