“Every patient is special.”

This is the foundation behind drug development and production. The pharmaceutical industry has to follow heavy regulations and guidelines to ensure the products are safe for consumption and the process adopted for manufacturing is reliable. The nature of this industry calls for the highest standards of production precision and accurate product and process review. Chemical analysis in downstream manufacturing is performed in off-line laboratories, remote from the manufacturing site. These results are often not provided fast enough to control and monitor the downstream process with maximum efficiency. Although traditional control levers have produced products of acceptable standards, they are not able to attain the highest quality at the lowest cost. This provides the motivation for advanced process control and optimization.

In this light, many pharmaceutical and biopharmaceutical companies are moving towards process optimization and real-time process monitoring to enjoy the advantage of product efficiency and product quality. This has given rise to Process Analytical Technology (PAT) initiative, created formally by the Center for Drug Evaluation and Research (CDER) branch of the FDA in 2002. It aims to identify, explain and manage all critical sources of variability. It also allows predictability of the product quality in an accurate and reliable manner due to alterations in process parameters, raw materials, manufacturing, environment and other conditions. This frame work allows for a greater understanding of the process and hence would allow greater control. It allows in-line and real-time measurements of performance. The biggest advantage of this technology is its ability to minimize the risks of poor process quality and reduces regulatory concerns.

Judging from the enormous advantages that process optimization (particularly PAT) provides, it is no surprise that many pharmaceutical and biopharmaceutical companies are moving towards enhancing their understanding of their processes, and engaging with the technologies that would provide them with greater process control.

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