Challenge
In this client's batch model, scaling up from small development to production batches was always a challenge, primarily due to differences in the size of equipment between the development and production facilities. Additionally, if laboratory sampling in the batch process determined that material was out of spec, the entire batch would have to be rejected. WIP was constantly a major expense due to excessive development runs to determine CPPs and other material and operational parameters.
Approach
We developed a Continuous Direct Compression process centered around a DeltaV control system. Implemented in development and production facilities, each facility included identical scale equipment to keep development at scale and moving rapidly. SynTQ and PAT sensor implementation allowed real-time and continuous release, eliminating the need for time-consuming quality assay batch operation processes. This process makes it possible to reject small tablet batches rather than entire batches.
Results
Process scale up has been eliminated from development to production, reducing a substantial amount of time, resources and money in drug launches. The overall savings for the client are in the millions of dollars.
