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?