A modern biopharmaceutical production site has numerous layers of interconnected processes and dependencies, both within the site itself and throughout the supply chain.
And while biopharmaceutical production has never been simple, multiple factors and industry trends are rapidly increasing the level of complexity to a point that is impossible to manage without a fully integrated factory.
The biopharmaceutical Smart Factory requires full integration, both within the factory from MES to the operators and production equipment, but also up to the ERP and horizontally along the upstream and downstream supply chain. This is not just a technology challenge.
One of the contributing factors to the increase in complexity is the development of new advanced therapies, such as biotech, stem cells, or cell and gene therapy. Biopharmaceutical components such as large-molecule proteins and antibody-like biomolecules present vastly different challenges than chemical compounds.
The common denominator for biotech products is that they are more complicated to manage compared to traditional pharmaceutical products, both in the supply chain and production execution.
Managing the complexity in advanced therapies requires real-time access to data from those processes from manufacturing and supply chain.
The advances in treatments and greater insight into how different individuals respond to them has also created a rising demand for specialized medicine, which target specific populations and sub-categories of patients. The ultimate end-goal is the ability to treat each individual patient with products tailored to their unique needs, medical history, and genetic profile.
The movement towards personalized medicine requires a dynamic production environment capable of producing micro-batches on demand. This is impossible to do without a fully integrated production and supply chain, which is able to adjust product recipes to match patient data and ensure that the finished product is registered, serialized, and delivered to the right location.
Organic growth can be difficult to manage in itself, but mergers and acquisitions add a whole new layer of complexity to pharma production. When two companies merge into one or new production facilities are added to the manufacturing and supply chain network, both IT and the rest of the business often struggle with the challenges of unify diverging IT/OT strategies, infrastructures, non-harmonized master data, and system standards.
If a pharma company acquires an existing production site, there are many complex decisions to be made, such as whether to replace the existing ERP system or update the platform that collects data from the production lines. In many cases, these existing systems have functionality and dependencies which is critical for managing production.
Adoption of cloud computing is increasing across virtually any sector and the life sciences industry is no exception. Pharma companies are eager to unlock the potential of cloud-based alternatives to on-site systems like MES.
Today, only about five percent of pharma companies operate cloud-based MES, but that number is likely to grow fast. The switch is coming, and we see multiple vendors launching cloud-based platform solutions or new companies coming to market with innovative cloud-based manufacturing platforms. Managed cloud solutions reduce the pain of cybersecurity, which is another cost intensive area. But before migrating to the cloud, pharmaceutical companies must first consider the complex implications for their legacy IT, existing production equipment, cybersecurity, and regulatory compliance.
It is therefore obvious that the Smart Factory is essential for the biopharmaceutical industry due to the increasing complexity of advanced therapies, the demand for personalized medicine, and the challenges posed by mergers and acquisitions. Fully integrated systems within the factory and across the supply chain are necessary to manage these complexities effectively. The adoption of cloud-based solutions is growing, offering benefits like embedded cybersecurity management, but requires careful consideration of connectivity to on-premise systems and regulatory compliance.
In conclusion, the Smart Factory is not a passing trend but a critical advancement for life science companies to stay competitive. It will be a pre-requisite when it comes to managing the intricate demands of modern (bio-)pharmaceutical production.
The Smart Factory is crucial for dealing with the challenges of modern pharmaceutical production and supply chain. Do you agree? What are your perspectives on the emergence of digital platforms in manufacturing?
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