Supply Chain Management Part 1: Getting it Right from the Start
Guest Editor: Dr Jean Stanton, J&J, USA The cell and gene therapy industry is entering an exciting phase of accelerated growth, which carries many logistics challenges. Part 1 of the Supply Chain Management spotlight looks at the various hurdles and measures to overcome the complexities at the start of your supply chain including: Material challenges for cell and gene therapy products, qualification of raw and ancillary materials, harmonization of testing criteria and analytical tools and insight into the traceability of reagents. Cutting through the complexity and inconsistency in the language used to discuss the quality of raw materials required across the commercialization pathway. When should a company start to use GMP “level” materials; what are the implications for process development and cost of goods? Standardization across the industry - do we need it and can it be achieved?