SIPAT — The Software Heart Of PAT

Regulatory agencies and patients, science and technology are forcing rapid change on pharmaceutical manufacturing. Manufacturing efficiency and innovation are high on the agenda of the big pharma and will be secured by those companies that innovate successfully. The US Food and Drug Administration (FDA) made the point vividly when it observed: "a recent estimate of potential world-wide cost-savings from efficiency improvement is suggested to be as high as US $ 90 billon. This would be equivalent to the current cost of developing 80-90 new drugs every year".

Change will occur in many aspects of pharmaceutical manufacturing. Process Analytical Technology (PAT) is only one aspect but it is of major significance for the industry. PAT fits nicely in the FDA's more general view of how to improve pharmaceutical manufacturing, described in the ‘good manufacturing practices (cGMP) for the 21st century' initiative. The cGMP initiative stimulates process know-how and understanding and puts PAT forward as the enabler to reach this understanding. PAT offers companies in bio-API, chemical-API and secondary manufacturing the possibility to gain better control of their processes, to design quality into the production process and eventually to move to real-time product release. It brings major benefits in terms of product quality, reduced time to market, and tighter and more responsive supply chains.

Today, Process Analytical Technology (PAT) has become a buzz word in the pharmaceutical manufacturing world. However, it should not be considered as a trend, but regarded as a new technology that is here to stay. Some (larger) pharma companies are already further down the PAT learning curve, while others are struggling to appreciate the full potential of PAT - seeing it only as a way to replacing the current off line tests with on line analyzers. All are challenged to find the most optimal way to introduce PAT and to select the right tools and infrastructure to match future manufacturing needs.

In this White Paper, we review what PAT is, why pharmaceutical companies should implement PAT and the factors that will determine its successful development. We look at the tools companies will need and consider the organisational development of PAT implementation as well as the technological aspects. We also provide an overview of Siemens' new SIPATTM solution. It links those tools necessary for a PAT system architecture and is designed to meet the specific requirements of the pharmaceutical industry.