When the World Health Organization (WHO) declared COVID-19 to be a pandemic in March 2020, the pharmaceutical sector burst into action.
By May, there were more than 1000 clinical trials ongoing and, by August, 167 vaccine projects were under way. By nature, the pharmaceutical industry is driven by development.
Yet, pharmaceutical engineering has not always kept pace. Here, Giuseppe Menin, Industry Manager for Pharmaceuticals at COPA-DATA, along with colleagues from the International Society for Pharmaceutical Engineering (ISPE) 4.0 Plug & Produce working group, explains why digital integration in pharmaceutical manufacturing must evolve.
Despite its advances in medicine, pharmaceutical plant architecture has remained relatively unchanged in the last few decades. These sites typically operate with legacy equipment and often use traditional automation systems.
This design uses separate levels of automation for different types of operation. For instance, business applications such as enterprise resource planning (ERP) and product lifecycle management (PLM) will operate in one silo, whereas manufacturing execution systems or process monitoring applications such as SCADA software will remain in another.
However, as connectivity and integration become ubiquitous in other manufacturing environments, there is an opportunity for the pharmaceutical industry to follow suit. So, why, in an industry so heavily associated with advancement, is there hesitation?
With its complex regulatory requirements and substantial reputational consequences should something go wrong, the pharmaceutical industry is certainly more risk-adverse than other sectors.
Although traditional automation architecture may be tried-and-tested, it does not provide an optimal way to use data in modern facilities. Let’s say a plant operative wants to remove inefficiencies from the manufacturing process.
To determine areas for improvement, the operative would need to extract subsets of data from different systems, such as the manufacturing execution system (MES), laboratory instrument management system (LIMS), ERP and SCADA.
In this example, an operator would need to take multiple steps between the laboratory, production and enterprise space to gather all of this information — and that’s not to mention the difficulties they may face when attempting to collect data from unfamiliar systems.
In an ideal world, this data would be integrated into a harmonised, easy-to-understand interface, providing the operative with a ready-made method to spot inefficiencies.
There are already technologies that enable some integration for pharmaceutical manufacturers, but this software integration by dedicated interfaces tends to come at a high cost and doesn’t provide the full data harmonisation required to meet today’s needs.
In truth, the industry needs a complete shift from this architecture type and a move to a services-oriented structure in which integration is the rule, not the exception.
A service-oriented architecture will operate as a grid of modular microservices. As opposed to a collection of hardwired systems, this architecture model will allow more flexibility and agility by giving users easy access to a wider pool of data.
Consider it to be somewhat like making a meal in a kitchen. Although you may know exactly where to find your ingredients and equipment, the process of collecting these items from separate areas of the kitchen is far more longwinded than having access to a laid-out buffet.
That’s not to mention the painstaking task of cooking — or, in this case, analysing the data — when you’ve retrieved your items.
By choosing a buffet of data, as enabled by the service-oriented approach, pharmaceutical manufacturers can reap considerable benefits. The model allows for more flexibility by enabling the quick assembly and disassembly of systems in the architecture.
It also enables better scalability than previous models by ensuring that the data can be reorganised and presented in a way that’s beneficial to whoever is looking at it.
Returning to our earlier example, an operator will no longer need to investigate what system each dataset resides on. Instead, the data can be distributed in various services and accessed from a single interface, regardless of where it is located.
Most importantly for the pharmaceutical industry, though, this architecture model can also be achieved while maintaining necessary cybersecurity and data integrity compliance requirements by automating configuration and validation processes.
Time to switch pace
At the time of writing, more than 170 teams of researchers are in the process of developing a COVID-19 vaccine — twelve of which are already in Phase III efficacy trials.
As the pandemic has demonstrated, the pharmaceutical industry moves fast … and the technologies used in pharmaceutical manufacturing should be advancing too.
The ISPE Pharma 4.0 initiative is working to ensure this happens. The group is designing new architectures to accompany the pharmaceutical sector towards more flexible, interoperable and sustainable production.
Pharmaceutical manufacturers must embrace a paradigm shift in how automation architectures are traditionally constructed to keep pace with the industry’s product development, moving away from a system-oriented world into a services-oriented architecture.
Anton Granget, IIoT Consultant at TechPivot, Kim Hewson, Automation Solution Director at GlaxoSmithKline, Martin Kuckelinsky, Head of Automation Engineering at Takeda, and Giuseppe Menin, Industry Manager, Pharmaceutical, at COPA-DATA.