Accelerating Pharmaceutical Innovation

Siemens is using its considerable experience in the application of Process Analytical Technology (PAT) in industries such as food and beverages and the chemical industry to help accelerate change in pharmaceutical manufacturing. With the launch of the Sipat software suite, Siemens is applying its expertise to assist pharmaceutical companies in their implementation of PAT.

Regulatory and financial forces are pushing pharmaceutical manufacturing toward rapid change. PAT represents an exceptional opportunity for pharmaceutical companies to improve manufacturing performance, reduce manufacturing costs, reduce time to market, and improve supply chain responsiveness. PAT allows companies to design quality into the process and move to real-time product release.

The scope for process improvement in many aspects of pharmaceutical manufacturing is considerable. The US Food and Drug Administration (FDA) has noted that the potential worldwide cost savings from efficiency improvements could be as high as US $90B, which is equivalent to the cost of developing 80 to 90 new drugs every year.

The pharmaceutical industry has been slow to adopt PAT in the past, in large part because regulation based on off-line batch inspection slowed progress toward more innovative continuous in-line manufacturing. Now, however, the regulatory landscape has changed. The FDA is engaged in a major drive to encourage the spread of PAT as part of its quality initiatives and cGMPs (current Good Manufacturing Practices) for the 21st century. The FDA's PAT guidance emphasizes the agency's belief that significant opportunities exist for improvement and innovation in pharmaceutical manufacturing by moving from empirically derived trial-and-error methods to rigorous mechanistically based and statistically controlled processes.