Quality control is a critical step during the production of high value pharmaceuticals. Traditionally, analysis is performed by extracting samples from the reactor, and taking them to the laboratory. However, definitive results can cost valuable time, reducing productivity, and increasing the risk of poor quality. It doesn’t have to be that way.

Process analytical technology (PAT) provides real-time analysis at the point-of-need. In other words, data is measured, and knowledge used to drive faster decisions where the valuable reactions take place. Verifying quality control throughout the process, rather than at the end, is revolutionising pharmaceutical and biopharma industries, and continues to accelerate production and processes across a range of enterprises.

Instrument miniaturisation is the “Lab-to-Sample” key that makes this possible

For PAT systems to be easily integrated into manufacturing operations, instead of being confined to a laboratory to analyse different samples, the aim is to take the laboratory to the sample using a variety of miniaturised instruments, such as:

• Mobile laboratories
• Lab on a chip
• Raman spectrometers
• Portable mass spectrometers

Until recently, mass spectrometers, in particular, have had a reputation for their large size, power intensity, expense, and maintenance costs. Sample analysis of any given product could often take days, or even weeks to turnaround in a laboratory setting. However, miniaturised mass spectrometry instruments are now accelerating the deployment of PAT systems in many industries, as they can be integrated directly at the point-of-need to increase productivity, profitability, and real-time data analysis.

Implementing PAT systems in a variety of applications

Although originally developed for the pharmaceutical industry to improve quality and efficacy at several intermediate steps rather than at the end of design and manufacturing operations, PAT can be deployed in a range of industries, including:

• Biopharmaceutical
• Biochemical
• Biologics
• Physics
• Electronics
• Engineering
• Environmental monitoring
• Industrial manufacturing
• Nanotechnology
• Genomics

The common objective is to establish a method that can monitor, assess, predict, and control quality throughout any manufacturing or testing process.

Establishing predictable and quantifiable relationships between raw materials, intermediates, and final product quality ensures optimal process parameters to deliver the highest quality, faster, and at a much lower cost. This explains why more industries are developing and implementing PAT systems into their processes.

Co-development between analysts, chemists, and engineers is integral to the success of PAT systems

Quality-by-design (QbD) strategies are now a prerequisite for product development across most industries. QbD determines the products’ manufacturing processes have been considered during its development stage (rather than left until later in the process). QbD considers better access to more detailed product and process information at the point-of-need in real-time, driving the demand for miniaturised technologies, such as mass spectrometry. Improvement in QbD will offer many benefits, including:

• Cost-effective end-to-end research process
• Instantaneous, real-time analysis
• Reduced development and manufacturing costs
• Less process variability
• Improved quality metrics
• Increased productivity
• Higher supply chain reliability

Real-world examples of how PAT systems are transforming analytical chemistry

As the first company to miniaturise mass spectrometry for point-of-need use, Microsaic Systems in conjunction with Modern Water and the Aptamer Group are integrating mass spectroscopy-based identification systems to allow real-time monitoring of water systems across the globe. Since joining the EcowaterOS consortium, over 20 years’ experience developing microchip-based equipment has allowed Microsaic to play an integral role in the real-time detection of contaminated water, aiming to mitigate the global water crisis.

What does the future hold for process analytical technology?

When it comes to real-time PAT systems, the possibilities are endless. As stricter regulations in biologics, bioprocessing, and biopharmaceuticals come into force, so too will the demand for efficient quality-by-design (QbD) strategies. Operators, managers, chemists, and engineers need access to more detailed product and process information in real-time (both on-line and at-line), which can easily be achieved by deploying PAT at the point-of-need where reactions and processes are taking place.

For more information on how Microsaic Systems can help you improve the efficiency of chemical and biological workflows, contact us.