There is no doubt that metrics are an important component of any well run pharmaceutical process. Without knowledge derived from the data that details the critical process parameters, it is like running blind into a storm without a compass or GPS with which to navigate.
Modern biopharmaceutical processes are extremely complex and require synchronization of many process parameters. Without this attention to detail, it is impossible to generate the type of operating capability that produces a consistently made product with very tight technical and quality specifications.
In developing Lean approaches to these manufacturing processes, metrics provides the information which is the life blood from which biochemical engineers can balance the needs of meeting quality specifications with running the process plant as efficiently as possible.
A key metric in any biological process is the changeover time, since this is where production time is lost. As a result this is a valuable data set that requires keen focus by the operating group so that maximum productivity can be realized from the biopharmaceutical production plant.
Today, many biopharmaceutical plants run as multi-product facilities, so maximizing this changeover time is critical to maximize the plant’s operating capacity.
That said, even in the case of single product facilities, reduction in batch to batch turn around can also have a marked effect on the ROI for the plant provided that key unit operations like inoculum preparation and work up can be appropriately synchronized to assure that the tanks are ready to be re-inoculated with the next batch once they have been cleaned and re-sterilized.
This should be a key area of focus for both fully integrated companies that have their own facilities or CMO’s that provides manufacturing services for client companies. In either case, lost production time has an impact on both business models, although for CMO’s there may be a greater pressure because their income stream is entirely tied to throughput from their plant and not through revenue generation from product sales, unlike innovator companies.
Through careful application of process analytics, often with the help of pharmaceutical consultants, winning strategies can be developed to assure a “Right First Time” mentality is instilled in the operating culture, which enables this approach to make a meaningful impact on downtime reduction and production cycle time.
