The term process analytical technology describes a method utilized to control and measure the attributes in drug manufacturing that define product quality and efficacy. It contains characterizing the critical process parameters (CPPs) of the hardware that is utilized to make the product, which influences its critical quality attributes (CQAs), and afterward handling these critical process parameters (CPPs) inside defined limits.
All of these techniques and tools are intended to provide information in real-time or very close to real-time. Process analytical technology should be incorporated into activities leading to large-scale production like an early and late stage process development and process scale-up, because its purpose is to improve the quality and safety of manufactured goods. The adoption of process analytical technology process represents a cultural and technological revolution in the approaches utilized by a business or an industry to produce products and assure their safety and quality.
The driving factors of the market are increasing research and development spending by pharmaceutical manufacturers and contract manufacturing organizations (CMOs) investment by governments of emerging economies and quick technological advancements in analytical devices are driving the growth of the process analytical technology market. In addition to this, according to the research report of Astute Analytica, the global process analytical technology market is growing at a compound annual growth rate (CAGR) of 13.2% during the forecast period from 2022 to 2030.
The Benefits of Process Analytical Technology (PAT) are: -
Enhanced product quality
Process analytical technology allows real-time monitoring of critical quality attributes (CQAs) of the product during the downstream processing, which assures the constant production of high-quality products.
Improved process efficiency
Process analytical technology delivers real-time data on critical process parameters (CPPs) during downstream processing, which can be utilized to create process adjustments in real-time to optimize the process and improve efficiency.
Decreased process variability
Process analytical technology allows for a decrease the process variability by delivering real-time data on critical process parameters and product quality characteristics during downstream processing. This information can be utilized to identify the root cause of process variations and drive process advancements.
Declined end-product testing
By utilizing process analytical technology to control and monitor critical process parameters and product quality attributes during downstream processing, the requirement for end-product testing can be reduced, which can save time and decrease costs.
Enhanced regulatory compliance
Process analytical technology can assist in assuring regulatory compliance by delivering real-time data on the process and product quality during downstream processing. This information can be utilized to demonstrate that the process is controlled and that the product is consistently manufactured to a high quality.
In Conclusion
Overall, while process analytical technology delivers many benefits for downstream processing, it also offers several challenges that must be overcome to successfully implement and utilize process analytical technology in downstream processing. Despite the challenges, the benefits of process analytical technology in terms of improved process efficiency, enhanced product quality, and decreased end-product testing make it a valuable tool for the biopharmaceutical industry.
