Christopher A Bravery, Sarah Robinson & Scott R Burger
SUPPLY CHAIN MANAGEMENT PART 1: GETTING IT RIGHT FROM THE START
Cell and gene therapy medicinal products (CGP), like other medicines for human use, are expected to be consistently manufactured to a defined quality. That quality is demonstrated through preclinical and clinical studies to be suitable based on an overall assessment of the risks (including quality) and benefits of the product when used to treat a medical condition. Achieving a consistent quality product requires an overall manufacturing control strategy including control of materials, control of the process, control of any intermediates, drug substance and final drug product. Consequently the quality of materials, including raw materials, used to manufacture are paramount to the final CGP quality. This review aims to cut through various mythologies around raw materials by taking a regulatory science approach to discuss raw materials selection.
Submitted for peer review: Apr 1 2018 Published: Apr 5 2018
Citation: Cell Gene Therapy Insights 2018; 4(3), 207-225.