Approaches to Process Development

The cost and pace of developing active compounds for the pharmaceutical and agricultural industries is dramatically increasing. Efficient development of processes to prepare kilogram quantities of drug candidates and active ingredients is necessary to sustain the pace of drug development and recoup the expenses of development. Devising and implementing a reliable manufacturing process in a timely fashion are keys to maximizing profits from a drug or chemical within the exclusive marketing period allowed by a patent. The timely implementation of reliable processes is the key to continued financial health of pharmaceutical companies. The role of process research and development (R&D) is to ensure that high-quality material is provided on time to fulfill the needs of developing a compound. There is also growing realization that successful process R&D requires different equipment and different approaches from those used in conventional laboratory work for discovery of active compounds. Practical processes must be developed to reap the rewards of basic research, and without down-to-earth applied research there will be no sustained basic research. The reliability of scale-up operations can have a significant impact on cost of the drug substances, and process conditions must be chosen wisely. One of the goals of successful process development is to design and introduce a smooth-running manufacturing process.