Process Analytical Technology: An Industry Perspective

Process Analytical Technology (PAT) is a system for designing, analysing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes of raw and processed materials to ensure final product quality, the idea of which is to become more efficient while reducing over-processing, enhancing efficiency and minimising waste. In this roundtable, three leading pharmaceutical PAT companies offer their opinions on why PAT is becoming more and more essential to the pharmaceutical industry.

Viewing this question from the regulator’s perspective, PAT is primarily focused on reducing process variability. Integrating on-line measurement and/or modelling of critical quality attributes with automated feedback control of the process parameters impacting these attributes should reduce product variability. Reducing product variability will subsequently reduce the risk of releasing off-spec product into the marketplace. The push is to shift away from the historical quality assurance approach (i.e. testing quality after the process is complete) to a true quality control approach where the process is continually adjusted to maintain product quality. In addition, there are the benefits of cycle time reduction and increased process efficiency (e.g. increased yield, throughput and equipment utilisation) that are achieved by eliminating the delays associated with off-line assays, as demonstrated by Eli Lilly’s ten-fold increase in throughput enabled by moving HPLC assays on-line. Identification of critical-to-quality operating ranges should be accomplished much more efficiently with PAT in place throughout the process development and product manufacturing life cycle. Although this may be difficult to quantitate, it was a benefit of implementing on-line ion chromatography to measure amino acids that was cited by Genentech.