Manufacturing: Streamlining Smart Manufacturing

What’s driving digital transformation in life sciences manufacturing?

There are a variety of business drivers shaping the digitalisation of life sciences manufacturing. Pharmaceutical manufacturers now face the responsibility of delivering medicines and treatments more reliably and faster than ever before, which necessitates digitalisation and interconnected systems across their production processes. By embracing these technologies, companies can make ‘right first time’ (RFT) decisions that can help facilitate more efficient and successful product launches and maintain product supply to the patient. Sustainability is another critical focus, as organisations across life sciences prioritise the shift to greener manufacturing processes. By incorporating sound design principles and digital monitoring, companies across the supply chain can decrease their Scope 3 emissions by reducing the use of carbon, energy, water and solvents and the waste produced across the drug manufacturing process. To meet the demand for advanced therapies, companies must also prioritise cost-effectiveness and expand their capacities. By harnessing lean manufacturing principles, manufacturers can reset their cost base for materials, enabling them to improve product yield, capacity, cycle and batch release time through capital spend avoidance and inventory reductions.

Data-driven decision-making is a key enabler of business drivers, which can be optimised through a unified platform approach and ‘connected by intent’ philosophy, facilitating seamless data interconnectivity across all business operations and providing valuable real-time insights for driving improvements. When all these activities are underpinned by a collaborative culture alongside strategic partnerships throughout each stage of their processes, companies can drastically streamline their manufacturing operations.

The evolving role of MES technologies in life sciences

MES technologies hold central importance in digitalisation strategies for pharmaceutical manufacturing, thanks to their ability to fulfil crucial functions that align with core business drivers and objectives. One notable industry evolution has been the shift from traditional paper-based systems to electronic solutions. This digitalisation process has extended to all aspects of the manufacturing chain, allowing for greater efficiency, accuracy and data accessibility. Digitalising key stages of the process has enabled better tracking, real-time monitoring and improved overall operational control. MES technologies play a pivotal role in the pharmaceutical industry by not only enhancing efficiency but also ensuring strict compliance with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations in line with good manufacturing practices (GMP). These guidelines stipulate that pharmaceutical manufacturers ensure that documentation is available for inspection purposes. Provided their electronic documentation systems have been validated, these authorities permit the documents to be stored within them.1 By utilising comprehensive MES, manufacturers can streamline their journey to compliance with stringent regulations as they facilitate seamless automated documentation at each stage of the process. Providing an accurate and up-to-date record, these systems also help to mitigate the risk of errors and deviations that may occur during the manufacturing process.

Understanding the limitations of traditional MES approaches

Despite the extensive implementation of MES across even the largest pharmaceutical companies, a significant number of organisations have not yet implemented them into their operations and remain heavily reliant on paper records and paper-based processes that supplement their existing MES. From batch records to standard operating procedures (SOPs), logbooks, controlled forms, shift registers and more, many companies are operating with disparate documentation that can be challenging to track across departments. Making the shift to truly paperless processes can be a daunting task, historically often taking up to two years.2 As a result, this move may be difficult for some companies to justify. Traditional strategies to encourage MES transformation have often faced resistance across departments. This reluctance can be attributed to various factors, such as:

• A limited grasp of data and its capabilities
• Unfavourable perceptions of the value of change developed from previous efforts to modernise
• Disruptions to long-established workflows
• Lengthy and disruptive project implementation duration
• Doubts about the system’s benefits.

These sentiments can be felt in departments across clinical and R&D, laboratories and factory environments. This is because these specialised areas often operate independently using their own paper-based systems or standalone systems and may not fully integrate within the broader MES framework.

To overcome these limitations and challenges, it is imperative to move away from a mindset that reflects a more conventional school of thought around manufacturing processes. This mindset and resistance to change might maintain that processes have to be paper-based and rigid. Those holding this mindset may be hesitant to embrace advances in MES and might prefer to stick to their existing manufacturing methods, even if they are less efficient and prone to errors. By taking a comprehensive approach to expanding the application of MES across the organisation, companies can bridge the gap between using traditional paper-based processes and harnessing all the digital capabilities of MES.

How has digital-first MES evolved to meet today’s business drivers?

In recent years, the pharmaceutical industry has seen a considerable shift in the adoption and use of digital execution solutions. This has radically changed the perception of MES and ushered in its digital-first evolution. These digital solutions represent a set of technologies and processes that enable the execution of a digitalisation strategy throughout an organisation. From software applications to automation tools, these technologies play a pivotal role in streamlining operations, extracting richer data insights and enhancing communication across departments. To boost their MES and achieve true paperless manufacturing processes, many organisations are turning to disruptor technologies such as low-code and nocode solutions as part of their digitalisation strategies. These digital execution solutions offer streamlined, user-friendly interfaces, which allow for rapid application development and configuration, without requiring extensive programming knowledge. This can also make them potential solutions for processes that involve unique, individualised and small-batch production runs. Overall, these solutions are set to make a significant impact on the digitalisation efforts of organisations. It is predicted that low- and no-code platforms will enable 80% of users outside of formal IT departments to take more ownership of the development of solutions that will enhance their MES.3 As these digital solutions have evolved, accessing data that once demanded the expertise of data scientists has become significantly more user-friendly. This transformation enables better decision-making and enhances day-to-day operations for businesses across the life sciences industry. By offering greater accessibility, agility and openness to critical information, these data-driven solutions empower businesses to navigate their processes with greater ease and efficiency.

Integrating digital-first MES into a digitalisation strategy

To achieve the full potential of their digitalisation strategies, life sciences companies should consider the following:

By taking a modular and gradual approach to the development of their digital framework, companies can facilitate the adaptable and flexible integration of new technologies into their MES landscape alongside existing processes.

As companies begin developing their digital MES, they can build a robust data enablement strategy that aims to deliver accessible and contextualised data models. By doing so, they can define a single source of truth to form a strong foundation for data management.

By embracing a more adaptable approach to the implementation process, companies can customise their digitalisation strategy to meet their unique needs and achieve a tailor-made fit for their organisation.

While integrating digital-first solutions into their strategies, companies must be sure not to overlook the core capabilities of MES. By evolving their MES solutions with advancements in digital solutions, organisations can effectively strengthen their operational efficiencies.

A well-defined validation plan is key to ensuring that evolving MES solutions are fit for purpose and qualified for use across the organisation. By ensuring their systems meet the latest computer software assurance guidelines, organisations can streamline the validation process and confidently comply with industry standards.

Modern technologies, which are increasingly either native cloud, cloud-based or moving to cloud-based platforms, need appropriate validation plans to be defined. These plans need to consider the new technology requirements and ensure that these SaaS/PaaS-based solutions are validated for intended use while ensuring that the advantages and flexibility of using these platforms are still maintained. By adhering to the latest CSA guidance from the FDA, including ISPE and GAMP guidance for SaaS and PaaS platforms, organisations can streamline their validation processes, reducing time and effort by removing unnecessary overheads whilst still reaping the benefits and flexibility these platforms ultimately provide. By taking these factors into account, companies can streamline and accelerate their implementation of digital-first MES or digital execution solutions to achieve more agile and efficient operations.

Learnings gathered throughout this agile process of starting small and learning fast can also be instrumental in driving valuable business improvements that align with the company’s identified business drivers. Provided that appropriate validation plans, post-implementation support, comprehensive training, a clear road map and a governance framework are in place, companies can harness digital advancements in MES technologies to empower their business to take ownership of the system and utilise it effectively to meet their unique business needs.

What does the future have in store for MES in life sciences?

In the next five to ten years, the life sciences industry can expect a significant evolution of MES and digital execution solutions adoption across its manufacturing processes. The integration of digital solutions will continue to become more streamlined, with one notable transformation being the shift from a traditional pyramid approach to a more interconnected web-based system. We can also expect businesses to opt for tailored, composable solutions that address their changing business needs, rather than adopting a fully detailed or rigid MES. This modular approach will enable businesses to optimise their operations based on their unique requirements by allowing them to select and configure the elements that work best for them and leave out those that don’t. Although they are already well underway, we can expect to see an uptake in the adoption of innovative Internet of Things (IoT) technologies as connectivity becomes paramount in ensuring seamless data flow from various sources. This integration of IoT devices with MES and/or digital execution solutions will make data more accessible, bridging the gap between shop floor operations and enterprise-level systems.

Overall, even though the life sciences industry has been hesitant at times to jump head-first into shifting away from paper-based systems, an increasing number of companies are now revising their approaches to harness the digital capabilities of innovative MES technologies. By taking a flexible and intentional approach to their digitalisation strategies, companies across this space can reap the benefits of evolving MES and digital execution solutions to streamline their manufacturing processes and meet their overall business objectives.