Process Analytical Technology (PAT)

Reducing risk with Process Analytical Technology (PAT) in drug manufacturing

Process analytical technology (PAT) is defined by the United States Food and Drug Administration (FDA) as a system for designing, analysing, and controlling pharmaceutical and biopharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).

The FDA Process Analytical Technology (PAT) initiative is an effort to facilitate the introduction of new technologies into manufacturing in the pharmaceutical industry. Today's competitive industrial environment requires drug manufacturing that continuously strives to improve product quality while reducing production costs. The goal of PAT is to enhance understanding and control this manufacturing process, which is consistent with the FDA's current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.

In routine manufacturing, PAT enables continuous and real-time quality assurance to ensure consistently high product quality and performance, batch after batch. Structured product and process development, using experimental design and on or in-line process analysers to collect data in real time, can provide increased insight and understanding for process development, optimisation, scale-up, technology transfer, and control. Process understanding then continues in the production phase when other variables (e.g., environmental and supplier changes) may possibly be encountered. Therefore, continuous learning over the life cycle of a product and applying those learnings is important.

A number of techniques are proving essential tools for PAT: namely NMR, FT-NIR and Raman  spectroscopy. NMR for PAT is independent on the sample matrix, needs no calibration and is able to deliver data quickly and frequently. NIR, FT-NIR and Raman provide a comprehensive range of PAT solutions based on vibrational spectroscopy.

PAT offers the pharmaceutical industry a framework for revolutionising its R&D and manufacturing businesses, to produce value for both themselves and patients. The main benefits associated from PAT for companies include:

  • Reduced waste, right-first-time manufacturing, higher production asset utilisation
  • Real-time quality assurance and validation
  • Increased movement toward real-time product release
  • Reduced raw material, work-in-progress, and finished goods inventories by lean manufacturing processes
  • Increased robust product supply to the public·

Bruker’s range of instruments provide the features and performance required to be easily incorporated into a PAT framework.