HN-Cell and Gene Therapies

Ensuring Effective Therapeutic Cell and Gene Therapy The aim of a gene therapy is to treat diseases by replacing, inactivating, or introducing genes into a cell. Therapeutic vectors (viral, non-viral, and engineered) are the genetic material vehicles for modifying cells in the body (in vivo) or outside the body (ex vivo). Cells modified outside the body can be cultivated from the patient (autologous cells) or a donor (allogenic cells) and then administered as a cell therapy. SGS offers a wide range of regulatory compliant cell and gene therapy services to help clients creating effective therapeutic cells or vectors.

C&GT product manufacturers must identify the appropriate therapeutic vector and precisely define specific structural characteristics. SGS has a great deal of experience in this area, using techniques such as: • Analytical ultracentrifugation (AUC) to conduct quantitative analyses of the C&GT product’s macromolecules

• Nanoparticle tracking analysis (NTA) to visualize vector particle size and contraction • Resistive pulse sensing (RPS) to detect and measure the size of particles in fluid • Electron Microscopy for empty and full viral particles • DNA fingerprinting for cell therapy banks, products and vector cell substrates

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