The Design of Safe, Efficient and Green Processes for API’s Throughout Product Lifecycle

Manufacturing performance is a key component of Pfizer’s effort in producing a “green product.” The design of green processes for manufacturing Active Pharmaceutical Ingredients (API’s) offers the greatest opportunity maximizing efficiency and reducing waste. In recent years a number of process tools, equipment and technologies have proven to be essential in augmenting our effort toward developing efficient, safe and green processes. Of particular importance at Pfizer is the use of Best Process Chemistry, BRITEST, Design of Experiments, High Throughput Reaction Screening, specialized facilities and the application of flow processes and bio-transformations, the latter of which are conducted in aqueous media. A case study demonstrating our approach to process design and optimization for maximizing API manufacturing performance throughout the lifecycle of a marketed product will be presented.