Pharmaceuticals

Competition in the global economies have sent pharmaceutical companies into an era of increased cost pressures and lowered market valuations. According to Mckinsey and Company, margin and earnings pressures are bringing an increased focus on traditional financial controls and operational efficiencies, in an industry that has historically given them little attention. Topics such as investment cost containment, and manufacturing cost reduction are becoming increasingly important to the top management.

A recent major study carried out at the Harvard Business School shows that process innovation, not just product innovation, can be the key to competitive edge. Behind the success of many new product introductions lies the development of novel process technologies that provide lower cost, higher quality, and increased flexibility. There is strategic corporate advantage in the integration of process and product development. These advantages can be captured by using PDC's structured conceptual design methodology.

FDA has introduced the concept of PAT (Process Analytical Technology) to understand and control the manufacturing process. The four key ideas of PAT (Quality by Design, Process Understanding, Continuous Process Improvement and Real Time Release) will have a major impact on the way drugs will be produced in the future.

Quality by Design and Process Understanding will substitute a major part of current "End-of-Pipe" quality control. As a consequence those companies who have gone through a thorough process development exercise will have significant advantages in regulatory effort. This is the stage where structured process synthesis is important and adds enormous value to drug development. Moreover, Continuous Process Improvement now allows changes to existing production processes once the chemical and physical transformation steps have been understood and the impact of the changes on the product quality can be predicted.