Cell and Gene Therapy Products

Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer to a human recipient. Gene therapies are novel and complex products that can offer unique challenges in product development. Hence, ongoing communication between the FDA and stakeholders is essential to meet these challenges. Gene therapy products are being developed around the world, the FDA is engaged in a number of international harmonization activities in this area.

Examples: Musculoskeletal tissue, skin, ocular tissue, human heart valves; vascular graft, dura mater, reproductive tissue/cells, Stem/progenitor cells ,somatic cells, Cells transduced with gene therapy vectors , Combination products (e.g., cells or tissue + device)

Related conferences: International Conference on Clinical And Molecular Genetics, 28-30 November 2016 (Chicago, USA); 6th International Conference on Genomics & Pharmacogenomics, 22-24 September 2016 (Berlin, Germany); World Congress on Human Genetics, 31October – 02November 2016 (Valencia, Spain); International Conference on Genetic Counselling And Genomic Medicine, 11-12 August, 2016 (Birmingham, UK); Cell & Gene Therapy Congress, 19-21 May 2016 ( San Antonio, USA); 2015 Midwest Conference on Cell Therapy & Regenerative Medicine September 18-19 2015 (Kansas City, Missouri); 2nd Cell & Gene Therapy Conference 9-10 September 2015 (Philadelphia, United States); Cell & Gene Therapy Europe 29-30 September 2015 (Barcelona, Spain); Cell Manufacturing and  Gene Therapy Congress 2015 2-3 December 2015 (Brussels, Belgium). 

Gene therapy products often initially appear promising because they reflect strong scientific rationale when they are proposed as treatments for specific, well-defined genetic disorders. In addition, some gene therapy products have been well publicized because they offer hope for the treatment of rare, disabling, or life-threatening disorders. Despite strong scientific rationale and publicity-generated enthusiasm, the field has not yet produced any products that have gone through clinical development and provided the evidence of safety and effectiveness. ommercial-scale manufacturing of cell-based therapies requires substantial infrastructure – a manufacturing facility setup for controlled production, skilled staff with expertise including cell therapy-specific manufacturing strategies, technology, and regulatory requirements.

  • Cellular immuno therapy products
  • Cellular & gene therapy products
  • Allogeneic & autologous therapy products
  • Cell based therapy products
  • Tissue based products

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