The supply chain: key considerations for biological starting material for ATMPs production
Cell & Gene Therapy Insights 2020; 6(8), 1135–1140
Advanced therapy medicinal products (ATMPs) is a particularly complex, novel class of medicines, with some distinctive supply chain requirements that significantly impact the manufacturing process. A critical element in the supply chain is the provision of biological starting material. It is essential to have a detailed knowledge of the sample’s properties and how these are affected by different factors such as time, temperature or transport medium to establish the distribution requirements. Additionally, it is indispensable to be fully aware of the legal framework where samples are regulated to comply with the requirements to guarantee their quality and safe use. The supply of starting material is a cornerstone for the establishment of a competent ATMP manufacturer, and its success relies on close cooperation with the procurement sites, a thorough knowledge of the starting material properties and regulations applying to it, together with an extended network of transport companies that could be involved in its supply.