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Process Analytical Technology (PAT) in the Pharmaceutical Industry

The pharmaceutical industry is constantly facing the challenge of balancing the growing demand for diverse products while ensuring a consistent supply, especially during periods of disruption such as the COVID-19 pandemic and, years before, the nitrosamine impurity crisis. Implementation of modern process analytical technology (PAT) can help combat this problem by ensuring more reliable product quality, higher yields, and greater throughput, ultimately delivering more saleable products on time and in full.

Thanks to advancements in digitalization in pharma, including extensive connectivity, increased computing power and advanced analytics, PAT has become more accessible and powerful, accelerating market growth and allowing improved supply chain management in the pharmaceutical industry.

What is PAT in the Pharmaceutical Industry?

PAT is an approach that involves the real-time monitoring and control of critical quality attributes (CQAs) during the manufacturing process of a pharmaceutical product. The goal of PAT is to improve process understanding, increase efficiency, and ensure product quality. It has been widely adopted in other industries and is slowly increasing in popularity in pharma in recent years due to the many benefits it provides.

One of the benefits of PAT is its ability to reduce variability in the manufacturing process, which is essential for ensuring consistent product quality. By monitoring CQAs in real-time, manufacturers can quickly identify and correct any deviations from the desired process parameters, and this in turn, increases overall efficiencies.

Another benefit of PAT is that it opens the door for continuous manufacturing and real-time release testing Instead of monitoring CQAs at the end of a run, samples are taken and analyzed during the process, allowing for rapid adjustments and corrections in real time. This saves time and reduces waste and lost batches, protecting margins.

PAT in Action: Ensuring Product Quality and Process Efficiency Across the Product Lifecycle

Whether it's a small molecule or biopharmaceutical therapeutic, PAT can be applied across the entire product lifecycle, from the active pharmaceutical ingredient (API) to the finished pharmaceutical product (FPP). AspenTech's transformative PAT solution offers unparalleled connectivity, data aggregation and modeling capabilities, enabling real-time product quality assurance and assessment. The solution also provides built-in tools for digitally mapping and automatically searching the process operating envelope, helping companies optimize quality, yield and throughput while maintaining compliance with current Good Manufacturing Practices (cGMP).

Typical Business Benefits of PAT

Implementing modern PAT solutions can lead to significant business benefits, including:

• Increased quality assurance: Save costs by preventing waste and rescuing batches.
• Reduced batch cycle time: Increase revenue through enhanced operational efficiency and additional batches per month.
• Reduced labor costs and reporting errors: Automate reporting to save on labor costs and minimize errors.
• Reduced process variability: Increase production by minimizing drift and eliminating guesswork, leading to higher revenue.
• Direct online measurement of product quality and continuous verification of process health: Enhance confidence for customers and auditors by ensuring the process remains under control.

Implementing PAT in Pharma with AspenTech

AspenTech, a leading software partner for optimizing asset performance and asset lifecycle, has developed a comprehensive solution that supports addressing the most pressing production challenges and opportunities in pharmaceutical manufacturing, including achieving more reliable product quality, higher yields and greater throughput. AspenTech's PAT solution is flexible, scalable, and easy to integrate with the processes, control systems, analytical instruments, and data historians already in place. The solution comprises several key components, including Aspen Unscrambler™, Aspen Process Pulse™ and Aspen ProMV®.

Aspen Unscrambler and Aspen Process Pulse work together to ensure product quality in real-time. The available information from traditional process sensors (flow, pressure, etc.) is augmented with real-time product quality measurements and monitoring through online spectroscopic instruments such as NIR and Raman. The benefit of the Aspen Unscrambler models deployed online in Process Pulse is unrivaled direct visibility into product quality and yield. Practical outcomes include more accurate batch end-point determination, batch-to-batch quality and yield trend analysis, and real-time release testing for every batch.

Aspen ProMV synthesizes the resulting combination of process and product data from many historical batches, creating predictive models and then automatically searches them to discover batch recipes that optimize quality, yield and cycle time. This automates a workflow that would be very challenging, if not impossible, to achieve with traditional approaches that manually explore the design space captured by the model.

Next, these models can be deployed online to predictively monitor whether the evolving batch operation is progressing to optimal quality, yield and cycle time or is drifting off course. Early warning and diagnostics capabilities enable informed and timely intervention as needed by operations personnel.

FAQs

What is Process Analytical Technology (PAT) and how can it benefit the pharmaceutical industry?

PAT is a system for designing, analyzing and controlling manufacturing processes through timely measurements of critical quality and performance attributes. It can benefit digital transformation in pharma by ensuring reliable product quality, higher yields and greater throughput, ultimately delivering more saleable products.

How can PAT be applied across the entire product lifecycle?

PAT can apply to all types of pharmaceutical manufacturing, including the production of the active pharmaceutical ingredient (API) and the finished pharmaceutical product (FPP). It can be used across the entire product lifecycle, from lab to pilot to production.

How does digitalization play a role in modern PAT solutions?

Industrial digital transformation advancements, such as extensive connectivity, increased computing power and advanced analytics, have made PAT solutions more accessible and powerful. In addition, these technologies enable real-time product quality assurance, assessment and optimization of manufacturing processes.

What are the typical business benefits of implementing PAT in the pharmaceutical industry?

Implementing PAT solutions can lead to increased quality assurance, reduced batch cycle time, reduced labor costs and reporting errors, reduced process variability and direct online measurement of product quality and continuous verification of process health. These benefits can ultimately result in higher revenues and cost savings for pharmaceutical companies.