Valued at $417bn this year, the sector is set to grow at a compound annual rate of 9.5% during the next 5 years.1
As the industry expands, higher demands are being placed on developers and manufacturers, presenting a plethora of challenges that can hinder the rapid and efficient commercialisation of new products.
Advancements in information (IT) and operational technology (OT) are key to offering innovators the insights they need to make and launch GMP-compliant medicines at greater speeds, report Trevor Marshall, Head of Consultancy, Life Sciences Manufacturing, and David Staunton, Head of Transformation, Life Sciences Manufacturing, at Cognizant.
Bringing these systems together whilst ensuring disparate systems are connected will allow industry players to “connect by intent,” referring to the implementation of seamless data connectivity throughout all stages of drug development. This includes R&D through to pilot and clinical trials, commercialisation and market launch.
Challenges hindering biopharmaceutical growth
Integrating IT-OT systems into manufacturing procedures offers the sector significant potential for growth; there are, however, a variety of key obstacles relating to the convergence of this technology that must be overcome to optimise its performance.
Biopharmaceutical manufacturers will need to make both time and resource investments to address three core issues.
- Poor data connectivity across operations: insufficient integration of data across business segments hinders the flow of vital information throughout key stages — both internally and with external partners in all stages of development — making it difficult to optimise processes effectively.
- A lack of meaningful, contextualised data: without this information, biopharma companies are hindered from improving their manufacturing procedures, scheduling and yield, potentially leading to costly batch failures, system performance issues and costly downtime.
- Quality and productivity issues: product contamination or deviations from the ideal batch profile can result in low-quality products or even batch failure — which can lead to recalls and a loss of revenue. Machine failures can also lead to downtime and increased maintenance costs.
Enhancing process efficiency by promoting connectivity
To overcome these challenges, a “connected by intent” approach, combined with advanced data analytics and artificial intelligence (AI) technologies, is increasingly being incorporated into manufacturing processes.
This gives staff the advanced insights needed to optimise production efficiency and accelerate development to launch GMP-compliant medicines quicker.
Utilising this approach to data allows it to flow seamlessly from manufacturing and lab instruments through automation, execution and historian systems to loosely coupled enterprise asset management and quality assurance systems, and — from there — into the cloud.
This provides a single source of truth for all GMP and non-GMP information, which can help manufacturers to improve product launch, yield, capacity inventory and cost credentials.
Speeding up time-to-market
As well as improving efficiency, connectivity empowers manufacturers to expedite the journey to market, optimise yield and capacity and streamline cycle and batch release times. It also allows businesses to recalibrate the cost base for labour, materials and energy.
When IT-OT connectivity is implemented effectively, manufacturers can drive significant value for their businesses by prioritising accelerated launches, sustainability and the capacity to maintain a competitive edge.
However, it’s not enough to simply invest without carefully considering how these technologies will integrate into and across a company’s disparate computer and data systems.
Monitoring processes in real-time
Once the product is on the market, biopharma companies can substantially improve the manufacturing process — as well as the scheduling and yield of a product — by harnessing a “connected by intent” approach to IT-OT convergence.
This method will enable them to combine the meaningful and contextualised information that’s flowing from the shop floor with the power of data analytics.
Major life science manufacturers, for instance, are using historical time series data from their OT systems, such as their programmable logic controller (PLC), distributed control system (DCS) and manufacturing execution system (MES) to build process data models.
These are then used as part of a digital twin to monitor their manufacturing process in real-time. These manufacturers can conduct equipment performance monitoring and process performance failure monitoring in near real-time, ultimately reducing the possibility of costly batch failures that might impact batch release.
Converging IT and OT platforms for optimised batch release
Although data analytics straddles multiple IT platforms, connecting these segments to the OT layer can bring benefits to the batch release process.
Not only are process insights enhanced and enriched, but companies also gain faster access to business-critical information, subsequently reducing downtime and system performance issues.
Access to real-time OT data also allows manufacturing processes to be scheduled in real-time. Historically, scheduled batches were recorded on paper, so the feedback on progress was slow.
Uniting IT and OT systems into one centralised digital system enables data flow from the shop floor, leading to a more granular, immediate visualisation of what’s happening to the batch.
With such real-time information, insights required for non-conformance investigations are available straight away. This allows manufacturers to create optimal production schedules, significantly reducing the prevalence of batch errors.
Connecting you and your partners
By employing the “connected by intent” tactic, developers can create a seamless flow of data interconnectivity across every level of their business and manufacturing operations; but this phenomenon doesn’t stop at internal processes.
Utilising advanced IT and OT systems can also help companies to share vital information with supply chain partners, meaning that authorised bodies also have access to the wealth of data from every stage of the development or post-commercialisation process.
From this, they can easily access insights from contextualised information that can assist them to optimise their own workflows to collaborate effectively with your business.
Bolstering productivity
GMP manufacturers who have already invested in truly connected systems are finding that it can further improve productivity whilst also benefiting manufacturing efficiency, flexibility, agility and security.
With the blended two-platform approach of shop floor data flow through the technology stack to the manufacturer’s data historian and cloud, developers can enhance process transparency with real-time insight into batch and equipment performance, significantly reducing the risk of batch failures.
As a result, biopharmaceutical companies can speed up discovery, development and commercialisation processes, as well as improve yield, capacity, cycle times and batch release times. They also have an increased capability to reset their cost base for labour, materials and energy.
Harnessing AI to maximise connectivity
AI has been a hot topic of conversation in the pharmaceutical industry ever since its inception and innovations in this field have caught the imagination of businesses and governments alike.
Its ability to mimic the creativity of the human mind more effectively than other available technologies — while reducing human error — has made it a popular solution for the optimisation of data processing and protocol management.
AI and related advances can be invaluable when facilitating a deeper process understanding, as it can employ multivariate batch analytics and machine learning for preventive maintenance.
By analysing data from a plethora of sources — including sensors and devices — AI-powered systems can detect potential faults earlier in the production process whilst also predicting when procedures are deviating from the golden batch profile.
As well as this, they can allow manufacturers to intervene when a machine is flagged as “likely to fail.” This again helps to improve production efficiency, reduces maintenance costs and minimise downtime, allowing companies to consistently meet high standards of quality.
Optimising machine and deep learning models with AI
As well as optimising production processes, AI can help engineers to autotune machine and deep learning models. This can be particularly valuable for those transitioning from a classical engineering workspace to an AI-driven one, as it can help them to optimise their models rapidly and with ease.
This frees up more time to focus on developing other sophisticated intelligence programs. By leveraging the capabilities of AI, biologics manufacturers can accelerate their digital transformation journey, optimise their operations and gain a competitive advantage in the marketplace.
Looking to the digital future
IT-OT convergence, harnessed by a “connected by intent” approach, is helping to shape the future of the life sciences industry.
Interconnecting systems inside the organisation between departments and externally between value chain partners can enable meaningful and contextualised data to flow throughout the development process, resulting in the acceleration of launches from Phase I and II clinical trial manufacture in the lab through to Phase III and commercialisation within the GMP factory.
The insights and efficiencies generated from these data flows can streamline the route to market and drive better business outcomes for biopharma companies post-commercialisation.
By leveraging interconnected systems, manufacturers gain access to a multitude of benefits including enhanced efficiency, improved flexibility, heightened agility, process transparency and strengthened security, as well as allowing real-time insights into batch and equipment performance.
Therefore, pharmaceutical manufacturers would significantly benefit from bolstering their IT-OT data connectivity and its associated technologies.
Reference
- www.thebusinessresearchcompany.com/report/biologics-global-market-report#:~:text=The%20global%20biologics%20market%20is,(CAGR)%20of%209.1%25.For more information