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Albina Pace from Emerson explains how digitalisation and software solutions are enabling manufacturers to perform faster technology transfers and make their operations leaner, helping them to achieve pipeline acceleration.
With increased competition and prices, pharmaceutical companies are looking to modernise and digitally transform their manufacturing facilities to ensure greater flexibility, efficiency, and reliability whilst helping bring products to market faster. The key areas of this transformation are accelerating the production chain, ensuring manufacturing flexibility and the integrity of all operational processes, accessing real-time analytics to enable decision-making in real time.
The COVID-19 pandemic required new vaccines to be launched rapidly. This highlighted the need to streamline work processes wherever possible enabling development cycles could be compressed. One way to achieve this is by digitalising technology transfer. This is the iterative process of moving product data through each stage of its development, from research to testing, licensing and commercialisation. It is also required when transferring the manufacturing process from one facility to another, or to a contract manufacturer. The speed at which technology transfer takes place directly impacts the time it takes to bring new pharmaceutical products to market.
Product data is critical, not only to satisfy regulatory agencies and obtain the necessary licences, but also to allow manufacturers to review steps and validate decisions. Transferring the huge volumes of data required is far from straightforward and each step presents a risk of violations that could delay or inhibit the development of new drugs. Historically, it has been difficult to perform technology transfer because the information is contained in different spreadsheets, Word documents and other records. As a result, the process has been time-consuming and required significant manual effort. Another problem has been that each stage of technology transfer is typically handled independently – with differing employees, processes, equipment, needs and locations. As a result, the process has traditionally been inefficient and prone to errors and delays.
By employing comprehensive process knowledge management (PKM) techniques, organisations can transform how they perform technology transfers, therefore move faster from research and development to production. PKM software helps by managing product and process specifications throughout the drug development lifecycle. PKM software creates an electronic repository to capture every decision made across product development. Automated integration with other key manufacturing systems, including the manufacturing execution system (MES) and distributed control system (DCS), enables the conversion of a traditionally paper-based process of technology transfer into an electronic work activity, with data seamlessly transferred between systems.
PKM software enables different job functions to work together to scale recipes and execute faster and more accurate technology transfers without the need for manual process and paper management. Should production be transferred to a contractor or another facility, pharmaceutical companies can simply download and provide all production process steps and activities, materials, critical process parameters and quality attributes. This helps to reduce product development costs, potentially reduce the time to perform technology transfer from years to weeks, and increase bottom-line profitability.
Quicker Batch Release
Another means of making operations leaner is to decrease the time and effort required for product quality reviews. When manufacturing products, before a product can be released to the market, paper documents or electronic batch records must be reviewed and products tested to ensure the production process and final product meet the required specifications. Should there be any deviations from these processes and specifications, this will need to be resolved. The ability to perform these tasks quickly and enable products to get out to the market fast is significant. Manufacturers do not want inventory being held up waiting for test results or review processes to be completed.
Digital solutions are helping to streamline these tasks. For example, the Quality Review Manager functionality of Emerson’s Syncade MES delivers review-by-exception in real time that enables batches to be safely released faster. Instead of waiting until an entire batch is complete before reviewing process exceptions, this software enables exceptions to be reviewed as they occur, while the batch is still in process. This provides a more accurate and timely response. Exception reviews can be identified and completed within hours of the exception occurring rather than weeks after the batch has been completed, eliminating potential delays in releasing products to patients. In addition, review by exception in real time can help to prevent batches from having to be discarded. Should a deviation take place, a quality team can intervene and make adjustments that get a batch back on specification.
Improved Operational Integrity
Lean operations can also be enhanced by implementing inline monitoring solutions. By measuring difficult parameters within the process, instead of having to take a sample to the laboratory, this can save significant time. It can also prevent potential errors or contamination. For example, spectral process analytical technology (PAT), available for Emerson’s DeltaV DCS, makes it easier to integrate Raman spectral sensors. Chemometric models can be run within the DCS to provide quality predictions and used for both monitoring and control. This technology enables manufacturers to close the control loop, utilising either traditional PID control or advanced control solutions. The outcome is a fully automated process that improves production efficiency.
Being able to collect data from the plant floor, contextualise it and make it available to analytics applications, generates opportunities to monitor equipment health and better understand how to optimise the process.
Efficient manufacturing can be undermined by unexpected production outages and can prevent orders being delivered in full and on time. Continuous monitoring and condition-based predictive maintenance create the opportunity to improve operational efficiency compared to time-based preventive maintenance. Predictive maintenance technologies, often supported by artificial intelligence and machine learning, are now being used to identify issues before they impact operations. For example, Emerson worked with one pharmaceutical manufacturer to develop a machine learning system that could detect sensor drift on a temperature sensor for a heat-treat skid. That implementation detected an aberration 60 days in advance, which allowed the company to save a batch worth over $1 million.
By focusing on critical points of failure and developing solutions that provide the time needed to react efficiently, this drives positive outcomes. Also, once a pending problem is detected, being able to schedule maintenance at an opportune time and understand the implications of any production schedule changes supports improved operational integrity.
Greater Manufacturing Flexibility
Digitalisation also supports the creation of more personalised medicine, which is crucial in the production of drugs for rare diseases and adapting to unexpected challenges, such as an epidemic. Many organisations are looking to deliver a wider range of more targeted treatments. Modern MES and real-time scheduling software enable this flexibility, helping teams make changes to production without upsetting performance.
Real-time scheduling software also supports production optimisation. Integrated with the control system, MES and other production systems, the software delivers an always current view of the operating state of a facility and identifies production scheduling impacts based on real-time conditions and constraints. The software enables companies to use proven facility operational models to accurately predict future plant resource availability, identify and eliminate bottlenecks, optimise scheduling and reduce downtime, allowing them to maximise production capacity.
Albina Pace is Industry Sales Director, Life Science Europe at Emerson.