June 2023 • PharmaTimes Magazine • 28-29
// DIGITAL //
The key to realising product and process visibility across the life sciences
The life sciences industry is experiencing a pivotal moment in its digital transformation. A storm of events, such as the global pandemic and technological advancements including breakthroughs in digitised research and manufacturing, have propelled companies towards embracing digital agendas.
To gain a competitive edge, businesses are now actively revolutionising their digital transformation strategies.
It has now dawned on many companies that traditional paper-based operations and fragmented data collection methods hinder their ability to adapt and evolve to thrive in the ever-changing market. Ultimately, the pandemic forced standard operations to change.
The capability to gather, combine and analyse data has become crucial for achieving success, affecting both regulatory compliance and profitability in the process.
Existing data silos are problematic because research and development and engineering design data is challenging for process line manufacturing stakeholders to access.
On manufacturing lines, the numerous types of equipment are often maintained by entirely different teams of engineers. It becomes difficult, costly and time-consuming in such environments to blend the data created across these various ‘islands’.
The data silos also make it complex to communicate evidence back to the regulators that a highly controlled production environment is being maintained.
With vast quantities of data being generated from many isolated systems – such as research, production and quality control − visibility of how that data impacts production efficiency and product quality is limited.
True digital transformation is about developing the capabilities of capturing, blending and contextualising data. It then enables that data to be quickly accessed and used by multiple organisational stakeholders.
Building data ontology (the ability to discern the properties of the various pieces of data and the relationships between them), building a data hierarchy, and designing a data architecture based on a consistent set of rules and governance all help to maximise the business value of the data that daily operations generate.
The ability to capture and analyse data should also extend to life sciences operations’ contracted manufacturing.
For example, from a regulatory standpoint, questions that pertain to drug ingredients, where those ingredients were sourced and when the drug was produced need to be quickly answered – even if the drug in question has been manufactured via third-party contractors.
The data must also be managed beyond just one plant within one geography. Enterprise-wide data must account for variations across multiple plants and global regions where regulatory statutes may differ.
Areas where digital transformation can yield benefits. To achieve the goals of high visibility and flexible operations, life sciences firms have launched digital transformation initiatives designed to help drive faster and more accurate business decisions.
Below are several examples of areas where significant digital transformation-based improvements are taking place:
The life sciences industry places great importance on traceability for safety reasons, which is crucial to regulators and customers alike. To ensure that drugs are manufactured to a standard, pharmaceutical companies must guarantee replicable production standards regardless of location.
‘True digital transformation is about developing the capabilities of capturing, blending and contextualising data’
Achieving this level of consistency requires clear visibility into laboratory and manufacturing operations, which can be facilitated by digitisation using digital services, artificial intelligence and analysis software.
These tools provide real-time feedback and increase connectivity, making cybersecurity a critical factor in safeguarding digitised operations.
During the COVID-19 vaccine rollout, major drug manufacturers adopted an emergency ‘all-hands-on-deck’ work approach. While successful in the short term, this approach became unsustainable due to ongoing labour shortages.
To tackle this problem and equip new employees with the necessary information, cost-effective solutions like ‘digital twins’ have emerged. These tools provide employees with guidance, making it possible to manage tasks effectively.
A digital twin is a virtual software model that analyses data and performs simulations to assess performance and identify areas where efficiency can be improved.
By pairing both virtual and physical worlds, manufacturers can analyse data in real time as well as monitor systems. This helps prevent problems before they occur, reducing downtime and creating opportunities for improved efficiency.
In life sciences industries, new employees can be trained in augmented reality and virtual reality environments, allowing them to address potential issues without disrupting existing operations. These AR-VR tools can also be used in engineering and manufacturing environments to enhance design and production processes.
Mastering both product and process data results in improved output quality. In some instances, batch processes can be converted to continuous processes, which increases output delivery and boosts output volumes, leading to a reduction in waste and improving sustainability in business processes.
Consistent production of high-quality products leads to energy savings, which is critical in the production of more sustainable drugs. The increased operational flexibility also allows for the reuse of single-use materials such as bioreactor processes that traditionally deployed disposable bags.
A convergence of events has disrupted how manufacturers operate, but it has also provided businesses with the opportunity to become more efficient and profitable.
Through digital transformation, we can tackle multiple areas of businesses, simultaneously giving life sciences firms a chance to evolve.
Indeed, by adopting new technologies, businesses can increase their efficiency, productivity and keep customers happy, allowing them to gain a competitive edge in this competitive landscape.
David Cooper, CPG Segment Vice President at Schneider Electric.
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