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A global pharmaceutical company is developing an innovative liquid product and needed to scale up and demonstrate ‘Proof of Concept’ (PoC). BPE defined the requirements for and then successfully executed process/equipment trials, both with the equipment vendors and secondly in situ within the client’s manufacturing facilities. Critical Quality Attributes and Critical Process Parameters were successfully established to provide a secure base for the trials. Design work was completed to support the trials in the manufacturing facilities, with minimal impact on existing operations being achieved.
Appropriate equipment vendors were identified and trial specifications defined. The project deliverables included:
•Basis of Design
•Design of process/product trial environments
•Trials Execution Plan