The life sciences industry has used process analytical technologies (PAT) for many years, and the chemical and petrochemical industries have applied them even longer. Manufacturers have long recognized the need to understand their processes and technologies. The acceptance and guidance by the Food and Drug Administration (FDA), however, is a recent development.
In September 2004, the agency published a guidance document (PDF) to promote a more scientific, risk-based approach to manufacturing drugs and to encourage innovation. This is a major departure from the agency's regulations (21 CFR Part 11), which were viewed by many manufacturers as having the potential to stifle innovation and increase costs.
PAT, which includes sensing technology, is an overall system for designing, measuring, controlling, analyzing, and predicting a manufacturing process in real or near real-time. The ultimate goal of the system is to enable you to understand your process deeply enough to understand and control variability and to accurately predict quality attributes. If you achieve these goals, you will be able to make adjustments in real time that will allow you to deliver a product that meets quality specifications. In the end, you will migrate from batch manufacturing to continuous manufacturing.
As pressure continues to build in the life science industry, companies need to find different ways of manufacturing drugs. Product recalls, shrinking pipelines, skyrocketing drug-discovery costs, demands for government price controls, and industry consolidation are all compounding factors. Manufacturing the same old way doesn't cut it anymore.
When drugs are made today, there are numerous quality checks throughout the manufacturing process. Before processing begins—after blending, drying, and compression—drugs are tested to ensure that they meet quality requirements. At the end of a process, there are additional terminal quality tests performed prior to shipping the final product. If the PAT system does its job properly, you move closer to real-time product releases.
In addition to the benefits of cycle-time and inventory reduction, PAT systems improve quality and reduce waste. For the same reasons described above, product quality becomes predictable, and the process will be known to produce a quality drug. Eliminating lost batches made to poor quality standards also reduces waste.
The wave of change sweeping the industry represents an enormous opportunity for life science companies. Many drug manufacturers are quickly moving toward innovation to realize the benefits that PAT solutions can provide. With the FDA and industry working hand in hand toward innovation, it's the perfect time to implement PAT systems.