The Rise of Digital Platforms in Pharma Manufacturing

Most pharmaceutical companies are recognizing and accepting the importance of digital technology to their business - in all segments of the company’s value chain. By appointing a Chief Digital Officer, many companies highlight the importance of digital technology, with this role leading the digital transformation across all business areas. Areas like marketing, drug discovery and clinical trial management are already using digital platforms successfully for many years. But pharmaceutical manufacturing often lags behind.

Digitalization of the Pharmaceutical Value Chain

Accelerating timelines of getting a medicine or therapy to market is crucial to all pharmaceutical companies. Today, digital technologies are widely used to accelerate time to market by significantly increasing the utilization of powerful technologies such as cloud computing, AI and machine learning to execute complex processes and managing huge amounts of data. Additionally, predictive modeling and simulation capabilities are employed to further enhance efficiency.

For example, clinical trial management has greatly improved in speed and effort over the last decade. This was primarily due to using Electronic Data Capture (EDC) platforms. These platforms enable laboratories and CROs (Contract Research Organizations) worldwide to collect, validate, analyze, and manage clinical data in real time.

Growing Complexity and New Challenges in Pharmaceutical Manufacturing

In pharmaceutical manufacturing, we have seen growing complexity in the last few decades. Novel therapies, like biopharmaceuticals or personalized medicine have a big impact on manufacturing modalities, but also on the integration of drug development with manufacturing and supply chain. With the rising use of CDMOs, the supply chain has become more and more fragmented. At the same time , the need for access to production data has increased for both CDMOs and their customers.

For the last two decades, we have seen pharmaceutical manufacturing transitioning from large scale production facilities towards more and more individualized therapies. This change has led to smaller batch sizes and a more complex supply chain. At the same time, compliance requirements have also increased significantly. For example, new anti-counterfeiting and serialization measures were implemented in manufacturing and supply chain.

Today many manufacturing organizations are facing significant challenges in

• production scheduling due to manufacturing more and smaller batches
• utilization of assets due to pressure on production costs
• being able to respond agilely to changing market demands: the COVID-19 pandemic demonstrated the vulnerability of the pharmaceutical supply chain. Manufacturing operations needed to adjust to new demand while ensuring continued supply of other vital medicine)
• collecting process data from production machines and equipment.

Why Traditional MES Systems No Longer Meet Requirements

Many manufacturing organizations started eliminating paper and collecting data electronically already 20 years ago. These initiatives usually aimed to get rid of paper and provide access to data to and from the manufacturing process. The system of choice was the MES (Manufacturing Execution System) as the central element of the manufacturing IT/OT architecture. MES had the purposes of managing and monitoring the production process in real-time, ensuring compliance with regulatory standards, optimizing efficiency, and maintaining product quality.

However, the traditional MES did not quite keep pace with the changing conditions in pharmaceutical production. As a result, many MES solutions in today's world have significant shortcomings:

1. MES are upfront investment-heavy
   Most MES solution require a significant upfront investment into a local IT infrastructure, integration with automation systems, ERP and other enterprise systems, and licenses for the full solution because it lacks a composable system architecture.
2. MES are based on pre-cloud technology
   Most (traditional) MES solutions are not based on a cloud-native technology. They require an installation in a data center on or close to the specific manufacturing site, which needs local IT personnel to operate and maintain the solution. For some solutions it is possible to operate them in a cloud-based environment. But due to their system architecture, they are not utilizing all the technical, security and integration advantages of a cloud-native solution.
3. MES are slow in responding to changes
   Most traditional MES solutions need the original solution provider or an integrator to implement system changes. The technology does not allow for rapid development and implementation of changes, and customers often need to wait for months. Additionally, there is only a limited number of developers available.

The shortcomings as mentioned above have also been recognized in other industries beforehand and resulted in a paradigm shift and redesign of the traditional IT/OT architecture concepts. The ability of being able to produce is key in many industries, not only in the pharmaceutical industry. Therefore, the digital infrastructure must ensure that all components supporting the manufacturing processes are available at all times. This explains to some extent the reluctance, both initially towards the adoption of MES and paperless production, and even today, the use of cloud-based solutions instead of on-premises systems. With the significant investments in cloud-based infrastructure and platforms for the last decade, other industries have already made the transition into digital and cloud-based manufacturing operations. These cloud-based platforms have made either the way into pharmaceutical industry or solutions providers started to develop life science specific manufacturing operations platforms.

11 Tangible Benefits of Digital Platforms in Pharmaceutical Manufacturing

Transitioning to a digital manufacturing operations platform provides significant benefits to pharmaceutical manufacturing compared to the traditional on-premise MES solutions:

1. Cloud-based systems are scalable: They can meet changing production demands without a huge investment in infrastructure or physical expansion.
2. Real-time remote access: enables access to production data and system control from any location. It allows remote work and decision-making.
3. Continuous Updates and Upgrades: provides automatic updates and improvements to software, ensuring the latest features and security measures without downtime for upgrades.
4. Advanced analytics and AI integration: leverages cloud-based computational power to perform advanced analytics, machine learning, and AI-driven insights that are often beyond the capabilities of traditional on-premise systems.
5. Lower initial costs: reduces upfront capital expenditure on hardware and infrastructure, with a shift to more manageable subscription-based pricing models.
6. Interoperability with other systems: facilitates seamless integration with other digital tools, platforms, and IoT devices. This improves overall system functionality and data flow.
7. Enhanced Data Security and Compliance: benefits from robust, cloud-provider security protocols and compliance support that are often more advanced and continuously updated compared to traditional on-premise security measures.
8. Improved disaster recovery: offers more reliable and efficient disaster recovery solutions through cloud-based backups and redundancy.
9. User-friendly interfaces: features intuitive, user-friendly interfaces and better user experience. This helps reduce training time and increase adoption rates among staff.
10. Low code Development: low code allows developers to focus on creating features and user experience of the application, rather than on writing lines of code. Production and process experts are able to configure the solution without deep programming knowledge. This increases productivity and decreases time for changes.
11. Composable Architecture: The composable architecture breaks down a complex ecosystems like manufacturing operations into more manageable chunks. It is a modular approach that involves splitting software into smaller, independent modules or components. Each module is designed to do a specific task or multiple related tasks. These self-contained modules can be individually developed, tested, and maintained. Updating or replacing individual modules is possible without disrupting the system as a whole.

Will MES Disappear Forever?

Traditional MES solutions and their on-premise architecture design will not disappear immediately. However, we have seen in other segments like drug discovery, clinical trials or marketing, that platforms have quickly replaced traditional system architectures. Also in manufacturing operations, digital platforms are on the rise. They will soon take over, starting with complex production modalities and eco-systems that require management and analysis of huge amounts of process data. These platforms will leverage cloud computing, AI, and machine learning more and more. With their help they will handle complex processes and large data sets.

In summary we see 3 key reasons motivating pharmaceutical manufacturers moving towards manufacturing platforms:

• Digital platforms are better prepared to adjust to the speed of change that is impacting pharmaceutical manufacturing operations
• Digital platforms provide immediate access to advanced analytics and AI, and the required computing power
• Digital platforms reduce the burden of managing the system infrastructure, cyber security, and constant system and application updates

Business Benefits of Digital Platforms

Digital platforms will provide a large portfolio of capabilities that are scalable to meet business needs instantly. Business benefits of transitioning to digital platforms may include:

• Instant implementation of digital workflows by process experts (low code implementation technology)

• Faster decision making due to online data visibility of production data

• Integrated functions and features beyond the Electronic Batch Record on a single platform

• Continuous improvement of production processes

• Enhanced collaboration that supports real-time communication and data sharing across teams

• Rapid deployment and flexibility allowing for quicker implementation and greater flexibility in adjusting to new requirements or process changes

• Reduced energy consumption and operational costs by utilizing cloud resources for optimal performance and efficiency

What is YOUR Opinion?

The foundational concepts of a Manufacturing Execution System (MES) — monitoring, tracking, documenting, and controlling the production process — are enduring. However, the architecture that underpins these functions is evolving. What are your perspectives on the emergence of digital platforms in manufacturing?

Join the conversation about the future of manufacturing operations and the role of platforms in advancing digitalization. Share your insights and help shape the dialogue on this transformative journey.

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