According to rarediseases.org, there are some 7000 rare diseases that affect one in every 10 Americans. It’s a sobering statistic that illustrates how biopharma companies are being forced to tackle more diseases on more fronts than at any point in history, reports Heather Coglaiti, Life Sciences Industry Leader at Rockwell Automation
A growing need for more targeted, smaller volume drugs and personalised medicines is now prompting a major shift in biopharmaceutical operations: manufacturing is increasingly pivoting away from large-scale bulk production and toward more multiproduct facilities that require complicated batching, frequent changeovers and meticulous tracking.
To meet these demanding conditions, biopharma facilities are learning to embrace Industry 4.0 transformation efforts to achieve new levels of agility; and, within the pharmaceutical industry, a “Pharma 4.0” evolution is making it possible to support more flexible and efficient operations that are capable of handling today’s rigorous and fast-changing production needs.
As diseases continue to evolve and cellular biology advances, complex process changes have created greater challenges for biopharma companies, especially as treatments for rare diseases increasingly become the focus of production. Drug manufacturers are under pressure to bring a wider portfolio of drugs to market … and do so more quickly — all while maintaining compliance and data integrity.
These conditions are driving a shift from large centralised facilities serving the world to smaller and more locally focused ones. It’s a shift that requires stronger convergence of IT and OT (Operational Technology) systems, greater process management and more efficient R&D operations to stay compliant within strict industry regulations.
To complicate matters, these shifting needs are happening right at the moment when manufacturing operations face unprecedented external pressures — including supply chain stresses, lingering COVID shutdowns, a scarcity of raw materials and manufacturing labour shortages.
In the face of these challenges, biopharma companies are looking to intelligent connected operations as a way to remain flexible amid ever-changing manufacturing requirements and operational conditions. It’s almost the perfect storm!
To remain competitive, agile and able to serve those who rely on their products, biopharma manufacturers are learning to leverage digital technologies to connect systems both horizontally and vertically, with enhanced data management for improved decision making, performance and compliance.
All the while, manufacturers are opting for modular and mobile equipment that creates more opportunity for “plug and play” operations and less dependency on manual intervention than ever before.
A flexible operations environment can take advantage of single-use technologies and prevalidated modular equipment to optimise capital utilisation, and advanced communications infrastructure and Industrial IoT technologies to easily and quickly swap out and repurpose assets.
Reactors, for instance, can be wheeled into position and connected using disposable tubing. The intermediate can be transferred back into a tote and sent into a centrifuge or depth filtration vessel. Downstream, media may be hard-piped through ultrafiltration, defiltration and chromatography columns. Carefully architected plug and play connectivity allows free movement and interchangeable processes, utilities and production rooms.
These modernisation steps enable the flexibility needed to execute smaller batches and optimise asset utilisation. A mobile design concept allows new levels of flexibility to accommodate changing market demands and competing priorities. This is made possible by a layout that is likely to be a much more open area with no fixed equipment and minimal segregation — allowing mobile equipment and materials to enter and exit based on demand.
Flexible operations enabled by Pharma 4.0 modernisation can unlock previously unattainable levels of efficiency and value for a wide variety of use cases. Consider, for instance, the distributed control system (DCS) that supports smart totes in a factory. Smart totes are integral to the movement of materials through the facility of the future.
But adding instruments such as temperature probes and level switches requires adding I/O and wiring it back to the DCS. This connection can pose DCS integration challenges that require engineering intervention and can result in costly delays and data integrity risks.
One proven solution is a hardened I/O module connected to docking stations via Ethernet cables.
Such an approach minimises the need for additional wiring and each I/O module maintains its own IP address. Using that address and critical setpoints unique to each unit, a modern DCS can automatically recognise a tote and alert an operator if the wrong one has been connected. Workers can then better identify and track each of the dozens of totes moving throughout their facility.
Smart mixing tanks is another use case worth examining. In a facility of the future, traditionally fixed bioreactors and mixing tanks are rendered mobile. For instance, a smart mixing tank can be moved, docked and identified via its IP address.
It can also be cleaned in different locations, allowing other equipment to move into the cleanroom and optimising production. As the tank progresses through production, workers can track when it has been used and cleaned … and confirm its hygienic status.
The enhanced digital connectivity and agility that comes with Pharma 4.0 transformation helps to empower the workforce with a fully managed virtual infrastructure, ideally supported by a data centre engineered specifically for production environments.
Visualisation is critical to maximising the accuracy and efficiency of this facility of the future. Fixed operator screens or terminals are no longer practical. Instead, workers are more effective when they have tablets or mobile screens that can follow them, and production, through the facility.
Location-based mobility solutions can recognise an operator’s location and enable relevant screens and applications while disabling others. They can also use location resolvers such as QR codes, Wi-Fi, GPS and Bluetooth beacons to help make sure that mobile users and devices only receive content in authorised areas.
Drug manufacturers are under pressure to bring a wider portfolio of drugs to market … and do so more quickly
For example, an approved operator standing in front of Reactor No. 1 will receive control of that machine. If they move, they can retain visualisation of Reactor No. 1 but will lose control of it. This feature keeps the worker informed while minimising the risk of erroneous operation. Such safeguards are critical in an environment in which valuable IP and extremely high regulatory standards are at play.
Intelligent digitisation also supports workforce training and system knowledgeability. For instance, a modernised production environment can allow any technician to walk up to any connected device and receive hands-free visual instruction on how to operate equipment or fix a problem.
Visualisation technologies can be enhanced with augmented reality (AR) that provides standard operating procedures directly to the operator. Appearing right before their eyes will be the information needed to assess a machine’s condition or perform a task — helping to mitigate downtime events and quickly resolve incidents.
Taken together, the range of Pharma 4.0 enhancements can bring radical benefits when implemented in biopharma manufacturing environments.
By optimising quality management, data integrity and productivity across the entire spectrum of factory operations, companies can achieve new levels of agility — including the ability to precisely control inventory through data-driven process control, achieve better labour utilisation through productivity enabling technologies and ensure ongoing quality and compliance when making process changes.
These are just some of the tangible gains that biopharma companies can achieve as they strive for more flexible manufacturing facilities to meet the unprecedented challenges, and opportunities, that define today’s marketplace.