Digital: The Digital Lab

What Pharma 4.0 looks like, the strategic role that a laboratory information management system plays and the presentation of a case study that underscores the power of a well-aligned digital strategy to catalyse innovation within organisations

Nicola Gardner at Thermo Fisher Scientific

In the wake of the Industry 4.0 revolution, Pharma 4.0 is transforming the global pharmaceutical landscape. This significant shift in the way that organisations work holds the promise of greater manufacturing agility, efficient connectivity and higher productivity for pharmaceutical companies. A successful transition to Pharma 4.0 can also fuel innovation, propelling organisations ahead of the competition and positively influencing profitability. Consequently, many companies have already embraced the transition, recognising the risks of lagging behind, which ultimately results in reduced revenue, profits and market share. But how does one reach Pharma 4.0? The importance of selecting the right digital solutions cannot be overstated. At the core of this is a laboratory information management system (LIMS) − the digital spine for the transformation − which translates the theoretical principles of Pharma 4.0 into everyday reality.

What is Pharma 4.0?

Pharma 4.0 is often described as the ‘cousin’ of the generalised Industry 4.0, encapsulating the transformational impact of automation and digitalisation on industries at large.

Deloitte outlined four key attributes of Industry 4.0 that are highly applicable and instrumental to the vision of Pharma 4.0.1

1. Vertical networking of smart production

Systems Production systems are interconnected, creating an integrated and communicative production environment. For pharmaceutical manufacturers, this translates to connected lab equipment and systems that facilitate real-time data exchange and faster decision-making, such as reacting to stock levels or pre-empted maintenance issues

Figure 1: The three steps needed to achieve digital maturity

2. Horizontal integration through new global value-creation networks

Silos are broken down and collaboration across various value chains is facilitated. Consequently, a unified network is created where data and insights flow freely across all departments − from R&D to production, quality control and even distribution

3. Through engineering across the entire value chain

End-to-end digitisation establishes a digital thread that captures and utilises data throughout the product life cycle to enhance process transparency, control and optimisation

4. Acceleration through exponential technologies

Exponential technologies are those that improve at an exceptionally fast rate, significantly impacting business and society. Such technologies can range from artificial intelligence (AI), advanced analytics and robotics, to cloud computing − enabling reduced production costs and expanding the availability of individualised products and services.

Fundamentally, Pharma 4.0 represents the pharmaceutical industry’s journey into a digital, networked and highly automated future − promising to enhance efficiency, spur innovation and ultimately enable labs to develop safe and effective treatments quicker.

Digital maturity: a crucial foundation

A critical requirement for an organisation venturing into the realm of Pharma 4.0 is digital maturity, but what does it mean?

In essence, digital maturity is the measure of an organisation’s readiness and ability to quickly make the most of possibilities provided by digital solutions. Being in such a position provides the opportunity for an organisation to create significant value and gain a competitive edge. Three key steps pave the way to digital maturity, as shown in Figure 1. Central to achieving each of these steps is a LIMS, which serves as a central hub that connects various elements, manages data effectively and prepares data for advanced analytics. A well-integrated LIMS can improve the connectivity within your organisation, drive automation and facilitate the application of AI and ML technologies, effectively setting the stage for a successful transition into Pharma 4.0.

Find the right LIMS for Pharma 4.0

In the pursuit of Pharma 4.0, the selection of a LIMS is a critical decision that can significantly influence an organisation’s success. However, not all systems are created equal. Different software offers varied features and finding the one that aligns with specific needs requires thorough research and consideration. Today, some suppliers offer a LIMS crafted with the specific needs of pharmaceutical users in mind, boasting a range of functionalities designed to enhance data collection, tracking and management. When selecting a LIMS, some of the key considerations include the nature of each lab within your organisation. For example, research and development (R&D) labs and quality assurance/quality control (QA/QC) labs have unique requirements, as shown in Table 1. Other features to seek in a LIMS to support your pharmaceutical workflows, regardless of the type of lab include:

• Collaborative work environments: Connectivity between collaborators both in your lab and across global sites to improve data-sharing

• Integration with software in use: For example, chromatography data software (CDS) and mass spectrometry (MS) data management to enhance workflow efficiency

• Data visualisation: Dashboards that offer key business and lab insights including resource availability and stock information for easier real-time updates (Figure 2)

• Lab automation: Compatibility with scheduling software for control of liquid handlers/synthesis workstations to boost lab productivity.

Better for companies and customers

The transition to a new LIMS brought tangible benefits to both the site and the wider business:

• Improved MLP specification management: The team can easily set up and configure MLPs, with a simple approval process

Table 1: Summary of considerations when selecting a LIMS for your labs

Figure 2: A range of dashboards, including stock overview, provide at-a-glance information for simpler decision-making

• Certificates of analysis generation: Certifications are produced automatically and simply configured and the team can check certifications directly in the software before issuing them
• Simple instrument interface: Data integrity is stronger and the equipment is quicker to use, easing data recording and peer review
• Straightforward regulatory compliance: The LIMS allows users to check live staff training records and instrument calibrations
• Process compliance: Interfacing LIMS with LES has changed how the team works, removing the need for worksheets, logbooks and validated spreadsheets.

Standing out in a competitive landscape

In this digital age, staying competitive and innovative demands a strong, strategic and well-informed embrace of digital tools and solutions − and the pharmaceutical landscape is no exception. Companies must embrace the principles of Pharma 4.0 to remain competitive and innovative, with a LIMS being central to achieving this. A carefully chosen LIMS, tailored to a company’s specific needs, serves as a cornerstone in supporting digital maturity and enables the shift towards a data-driven, connected and streamlined operation. With the right LIMS, labs can reduce the risk of errors by automation, increase efficiency by cutting down on manual processes and boost capacity by streamlining workflows. Together, these advantages enhance the scalability of operations, enabling companies to adapt swiftly to changing market demands and opportunities, ultimately supporting them to deliver their innovative products to market faster.

References:
1. Visit: deloitte.com/tw/en/pages/manufacturing/articles/industry4-0.html