Laboratory preparations - Import export

The step from the laboratory to manufacturing for clinical trials is a major challenge. Simple hand movements in the laboratory often cannot be easily translated into process steps of industrial manufacturing. We are specialised in such scale ups. Contact us for an initial discussion! Analysis We prepare your laboratory data and compare it with the possible process parameters at the contract manufacturer. If data or optimisations are still missing. We develop the test plan for this. We carry out certain scale-up trials (non GMP) at our technical centre. We accompany specific trials (e.g. with your API) on your premises or those of a plant manufacturer. Models and simulation From the data, we generate the process models you need for scaling up. You will also need these models for the submission documents. We use the data to simulate different scale-up concepts. So if you later transfer from the special CDMO for clinical production to the CDMO for commercial production

Our experts provide detailed laboratory analysis of the product, prepare documentation and dossier