Regulatory FAQs & common concerns for cell & gene therapy raw & starting materials
Cell & Gene Therapy Insights 2020; 6(2), 397–406
In cell and gene therapy, materials matter. However, misconceptions abound, exacerbating a lack of harmonization and standardization in key areas. For example, uncertainty around quality grades at the various stages of R&D is commonplace, and everyday terms are frequently misinterpreted or misunderstood, with potentially damaging ramifications for advanced therapy development, manufacturing and commercialization. Here, we aim to debunk some popular myths, provide practical guidance based upon long experience in the field, and clarify key regulatory considerations and requirements across the cell and gene therapy raw and starting materials area.