The Background

One of biggest challenges for the Pharmaceutical industry is to ensure timely and reliable access to safe, innovative, and cost-effective medicines for the world’s increasing and aging population both now and in the future.  The foundations of the business include a consistent supply of high-quality active drug or active pharmaceutical ingredients (APIs).  High-quality APIs require both consistent physical and chemical properties from batch to batch.  These properties directly influence both the quality and safety of the final drug product and are therefore critical to both efficacious patient therapy and patient safety.

In this highly regulated industry, the requirements around data gathering, data management and data control are becoming more and more stringent.  Large quantities of process and analytical data are generated during manufacturing processes and the integrity of this data is hugely important.  Therefore, the ability of the API manufacturers to deliver a consistent supply of API of the appropriate quality and meet all regulatory requirements is fundamental to the ability of the pharmaceutical industry to meet the world’s patient population needs. 

Industry has a number of challenges with meeting this requirement including 1) poor control and efficiency of the crystallisation process, 2) the systems and bandwidth to manage the shear volumes of data being generated and 3) maintaining supply of product of the required quality consistently to meet customer demand.