The role of raw materials in the manufacturing of cell and gene therapy medicinal products: practices and challenges
Cell & Gene Therapy Insights 2020; 6(2), 229–233.
The biopharmaceutical industry has increased the number of cell and gene therapy medicinal products under development. The complexity of the new technologies to enable these therapies and the regulatory expectations have also increased. Within this context, the role of raw materials in the manufacture of CGT medicinal products is examined. This commentary assesses the controls applied to raw materials and evaluates challenges and best practices ensuring product quality. The fundamentals of good manufacturing practices still apply. Well characterized materials from reliable suppliers are key elements to maintain a dependable supply of products for our patients.