Implementing Process Analytical Technology
– why it’s not just the latest buzz word in pharma/biopharma manufacturing.
Today, Process Analytical Technology (PAT) has become a buzz word in the pharmaceutical manufacturing world, with many viewing it as the latest trend in the industry. However, to consider it a trend is doing it a disservice – PAT is here to stay.
For those companies who appreciate the significant importance of PAT it is fast becoming integral to their manufacturing processes. The US Food and Drug Administration (FDA) noted “a recent estimate of potential world-wide cost-savings from efficiency improvement is suggested to be as high as US $ 90 billion. This would be equivalent to the current cost of developing 80-90 new drugs every year”.
For others that only see it as a way to replacing the current off-line tests with on-line analysers, they are missing the significant opportunities that PAT can offer to improve their processes and ultimately reducing their manufacturing costs. It brings major benefits in terms of product quality, reduced time to market, and tighter and more responsive supply chains.
Regulatory agencies, as well as science and technology innovators, are forcing rapid change in pharmaceutical and biopharmaceutical manufacturing. Manufacturing efficiency and innovation are high on the agenda of big pharma with the greatest rewards achieved by those who innovate successfully.
Process Analytical Technology (PAT) is only one area where change will occur in the pharmaceutical manufacturing sector, but it is of major significance for the industry. PAT fits comfortably in the FDA’s view of how to improve pharmaceutical manufacturing, described in the “good manufacturing practices (cGMP) for the 21st century” initiative. PAT offers bio/pharma/secondary manufacturing companies the possibility to gain better control of their processes, to design quality into the production process and eventually to move to real-time product release.
Upskill to advance your career in pharma/medtech sectors on-line
As a practitioner in the industry, knowledge of PAT (Process Analytical Technology) tools and applications are critical to your industry understanding. As PAT tools are becoming more frequently applied in pharma processes, you need to be up to speed with PAT and the latest developments in the field of study.