Technology, Supply Chain and Manufacturing (TSCM)
There are three Manufacturing sites across Europe. These European Manufacturing sites produce the majority of Astellas Europe's products, as well as other key active pharmaceutical ingredients.
TSCM is responsible for the supply of clinical trial materials within Europe and for drafting and reviewing the Chemistry, Manufacturing, and Control documents for both investigational and commercial European regulatory submissions.
Quality assurance of both clinical trial materials and commercial supply is also the responsibility of TSCM, which has oversight of QA systems within Astellas-owned Manufacturing sites, Astellas Sales and Marketing affiliates, and contract manufacturing organisations located throughout Europe.