Cerbios can conduct de novo process development from the Process Scale up to Preclinical Study Materials along with transfer in processes that need to be optimized or scaled up to fulfill regulatory or economic requirements.
Cerbios makes a great effort to develop processes for the customer after understanding their technical and business requirements. The processes delivered are cost effective, robust, scalable, validated, compliant and transferable. The R&D department of Cerbios offers significant expertise in the process of pre-clinical development. The company provides scientific solutions that range from design to execution for early drug development - to specialty chemistry chemical process development.
Typically, a small scale R&D run (called familiarization run or feasibility run) is performed in order to ensure that the process works as required.
Moreover, the familiarization run has the scope to confirm the viability of the procedures to obtain the desired product with acceptable quality and yield.
In cases where the results vary significantly from the expected, the customer is immediately informed, the project is re-discussed and tailor-made development process activities begin again accordingly.
After production, products are analyzed in our R&D analytical development laboratory using qualified instruments and equipment.
The service is offered only in connection with the production of pre-clinical, clinical and/or commercial batches.