Integrating PAT and robotics to bring pharmaceutical manufacturing to the next level

Martin Gadsby, Director at Optimal Industrial Technologies, looks at why robotics and PAT are a match made in heaven on the manufacturing line.

Ensuring high-quality, effective drugs that meet regulatory requirements and customers’ expectations are challenges that the pharmaceutical and life science sectors constantly need to address by means of robust and comprehensive quality assurance and process control strategies. The digitisation and automation of laboratories and drug manufacturing processes can be a powerful ally to these industries, specifically, the cooperation of PAT and robotics.

This establishes a real-time link between process control and process automation, which can be used to promptly implement quality assurance and manufacturing decisions. In this environment, the physical information from sensors and analytical instruments are passed on to a higher-level system for adaptive decision-making, i.e. PAT knowledge management, that communicates with industrial or collaborative robots to act promptly on the basis of the decision taken.

By leveraging real-time testing and dynamic responsive robotic process automation (RPA), drug developers and manufacturers can create a truly continuous processing framework that requires minimal intervention and reduces downtime to a minimum. This higher degree of visibility, traceability and responsiveness can lead to both improved and accelerated product development and manufacturing, as well as more effective risk management and associated corrective actions to ensure product quality and compliance.

Integrated PAT-RPA solutions are already a reality

Pharmaceutical filling and preparation of growth media for life science, for instance, is turning into an increasingly robotic process in order to reduce cycle times and increase consistency. When coupled with PAT monitoring quality via spectral analysis, this system can further increase its speed whilst reducing waste.

Researchers in this field have been able to create a high-performance, high-throughput automated robotic workflow for monoclonal antibody (mAb) and glycan purification that enabled the implementation of PAT and Quality by Design (QbD) approaches. Plate-handling robots are used to collect, prepare, incubate and test liquid samples. The solution reduced cycle times from over 18 hours to only 5.¹ This specific innovative system offers a fast and efficient method to produce biotherapeutics for cancer and autoimmune diseases treatment and prevention of xenograft rejection.

PAT and robotic arms address challenging applications

In addition, the use of integrated PAT-RPA systems can be extremely useful in sensitive applications such as those conducted within cleanroom environments. In these situations, rigorous aseptic conditions are a must to produce regulatory compliant sterile products. The use of fully automated manufacturing and quality assurance tools can significantly reduce contamination risk as well as particulate generation, resulting in higher drug quality and lower production of waste and off-spec material.

In particular, recent advances in robotics have allowed articulated robots to meet even the most demanding ISO 3 (Class 10), 2 and 1 cleanroom standards. In addition, these robots can be easily cleaned, are waterproof and can withstand sterilization procedures, such as hydrogen peroxide vapor disinfection.

Conversely, the use of robots and PAT in particularly hazardous conditions can minimise human operator exposure to certain compounds and ingredients. In this way, the combination of real-time testing, process control and process automation can increase operational safety and reduce health risks. More precisely, PAT knowledge managers can guide industrial robots in handling pathogens, highly reactive, corrosive and hazardous substances, conducting chemical reactions in extremely cold or hot environments, as well as ensure the materials are used and processed correctly.

When looking at innovations in the pharmaceutical field, it is evident that implementing integrated PAT-RPA systems can offer a pathway to success in offering more commercially viable precision medicine. Within this framework, the pharmaceutical product composition determines the processes that are required, and the associated factory robots and machines carry out the necessary operations.

In fact, PAT is the sole method that allows manufacturers to economically produce low volumes of personalised drugs and treatments according to different, unique recipes -customised to the individual patient – and test them individually, rather than in batches. RPA, on the other hand can be controlled by a PAT knowledge management platform to follow a specific recipe, providing the high level of accuracy and speed needed to perform different manufacturing tasks whilst keeping production costs low.

Interconnected Pharma 4.0

The connection of PAT and RPA also offers a starting point to integrate data from system-wide physical, operational, and robotic assets to drive not only manufacturing and quality assurance activities, but also maintenance, inventory tracking and many other variables and KPIs across an entire plant. This is, in essence, the level of interconnectedness that Industry 4.0 and Smart Manufacturing aim at.

Nonetheless, the synchronicity of PAT and RPA not only helps to build a Pharma 4.0 factory, but also it improves the practical everyday operation of pharmaceutical manufacturing systems by streamlining operations, lowering production costs and cycle times whilst increasing throughput and performance. Hence, the large-scale adoption of these technologies is not a matter of ‘if’ but ‘when’.

When committed to implement a successful integrated PAT-RPA, it is important for manufacturers to rely on skilled and knowledgeable specialists that have extensive experience in process automation, robotics and PAT. They can design and build bespoke solutions that address specific plant requirements in the most efficient manner, smooth the process before and after installation as well as ensure that the automated line is running at its optimal performance level. In this way, industries in the pharmaceutical and life science sectors can be sure to benefit from the most suitable solution for their specific applications.

References
¹ Doherty M., Bones J., McLoughlin N., Telford J. E., Harmon B., DeFelippis M. R., Rudd P. M. (2013) An automated robotic platform for rapid profiling oligosaccharide analysis of monoclonal antibodies directly from cell culture. Analytical biochemistry, 442(1), 10-18.