The pharmaceutical industry is undergoing a period of dramatic change. Pharmaceutical manufacturers today are challenged by increasing global competition, commoditisation, new regulations, and higher quality standards.
These market dynamics have made it clear that pharmaceutical manufacturers must fundamentally change their production processes to profitably compete in the global market while ensuring patients receive the highest quality products in time to make a difference in their lives.
The Food and Drug Administration (FDA) process analytical technology (PAT) initiative is at the heart of this inflection point in the industry. While not the initial intent, regulatory requirements have restricted the pharmaceutical industry’s ability to quickly deliver qualified drugs to the market while continuously enhancing overall quality and efficiency. In an attempt to transition the industry from one of procedural requirements to one of continuous improvement, the FDA has sponsored the PAT initiative.
The goal of this is to understand and control the manufacturing process in a way that is consistent with the current drug quality system. Or, as the FDA puts it, “Quality cannot be tested into products; it should be built-in or should be by design.”
PAT is a system for designing, analysing, and controlling manufacturing through timely measurements – during processing – of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.
It is important to note that the term ‘analytical’ in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.
New tools
There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. In the PAT framework, these tools can be categorised as:
- Multivariate data acquisition and analysis tools.
- Modern process analysers or process analytical chemistry tools.
- Process and endpoint monitoring and control tools.
- Continuous improvement and knowledge management tools.
An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance.
A desired goal of the PAT framework is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process. Such procedures, says the FDA, would be consistent with the basic tenet of quality by design and could reduce risks to quality and regulatory concerns while improving efficiency.
Gains in quality, safety and/or efficiency will vary depending on the product and are likely to come from:
- Reducing production cycle times by using on-, in, and/or at-line measurements and controls.
- Preventing rejects, scrap, and re-processing.
- Considering the possibility of real time release.
- Increasing automation to improve operator safety and reduce human error.
- Facilitating continuous processing to improve efficiency and manage variability.
- Using small-scale equipment (to eliminate certain scale-up issues) and dedicated manufacturing facilities.
- Improving energy and material use and increasing capacity.
To this end, Pavilion Technologies, a leader in advanced process control (APC) and environmental compliance solutions, and Thermo Electron, a leader in analytical instruments, have announced a worldwide strategic joint marketing agreement to deliver complete solutions of software, process analysers and consulting services to meet the pharmaceutical industry’s PAT needs.
Available immediately, the offering is intended to serve as a one-stop shop for pharmaceutical customers seeking proven, best-of-breed technology solutions from analysers to multivariate data analysis to model-predictive control.
“The key to the success of PAT is the ability to analyse your process and identify sources of variability which may include process, product, or disturbance-related variables. Organisations can then leverage this process understanding to continuously reduce that variability to cut costs, increase yield and enhance product quality,” said John Blanchard, senior pharmaceutical analyst, ARC Advisory Group. “Together, Pavilion and Thermo Electron provide a powerful solution that combines cutting-edge scientific and engineering knowledge with industry-proven technology solutions to minimise risk and maximise value to the pharmaceutical industry.”
Strategic alliance
As part of the strategic alliance, Thermo Electron and Pavilion will offer a complete pharmaceutical solution that will enable manufacturers to leverage real-time analyser data to build robust process models, enhance process understanding and improve production performance. The joint offering will include Thermo’s real-time process analysers, and Pavilion’s multivariate data analysis, Soft Sensor online analysers, model-predictive control, and predictive performance management software powered by Pavilion8.
The two-year agreement provides Thermo Electron’s pharmaceutical clients worldwide with access to Pavilion’s solutions. For more than
14 years Pavilion has helped leading chemical and food manufacturers deploy software solutions to transform large volumes of data into process understanding, and process understanding into real business value. Pavilion says it is uniquely suited to leverage investments in NIR sensors and other sensor technologies that produce volumes of online process data. Pavilion’s suite of software can mine volumes of data to identify what key process variables are affecting results.
The company’s suite of PAT Portfolio includes: multivariate data acquisition and analysis; off-line ‘what if’ analysis and simulation; off-line model predictive control; Soft Sensor online process monitoring and prediction; Soft Sensor online validation and back-up; online model predictive control solutions to achieve continuous improvement; and performance management solution to monitor and manage to key performance targets.
“We are pleased to partner with a proven technology leader like Pavilion, whose deep industry expertise has helped leading manufacturers in numerous industries increase performance results and enhance quality assurance for more than 14 years,” said Zafar Kamal, director of strategic marketing and new business development, Thermo Electron. “In selecting the ideal portfolio of best-of-breed solutions which support the PAT vision, Pavilion clearly stood out for the strengths of its entire suite – from multivariate data analysis, online Soft Sensor support and model predictive control capabilities.”
