Scaling up from clinical trials in phase I to large-scale commercial manufacturing the number of patients (i.e. doses to be produced) might go up by several magnitudes. As a consequence the supply of high-quality GMP grade raw materials is getting even more critical. The safest way to eliminate possible problems with the supply of GMP grade raw materials is having a supply agreement in place well before large-scale manufacturing is planned to start. Giving us a clear and reliable forecast of the amounts of raw material needed will allow us to have enough products available on demand. This will in addition allow us to produce large size batches for one customer.
To be able to provide our high quality raw materials at strongly increasing quantities we started facility expansions and took scale-up measures. We also have set up a warehouse at our US office to further improve our overseas supply chain for our American customers.