Have You Adopted A Manufacturing Execution System Yet?

By Aashi Mishra, Research Nester

Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency, serving as a link between the strategic planning of enterprise resource planning (ERP) systems and the practical activities carried out on the shop floor. This article explores the world of MES in the pharmaceutical industry by examining new market research, revealing the benefits of adopting such systems, key considerations, and an unbiased look at vendors offering MES.

The Benefits of Adopting MES In Bio/Pharma

MES acts as a conductor bringing together processes ensuring adherence to regulatory standards and facilitating streamlined production workflows. By implementing MES, pharmaceutical companies can lower manufacturing expenses, enhance quality, and boost efficiency. Key elements of MES in the pharmaceutical sector encompass:-

• Recipe/Formulation Management: MES enables pharmaceutical companies to establish and oversee production recipes and formulas, guaranteeing uniformity and accuracy in the manufacturing of drugs. MES also monitors inventory levels as it provides up-to-date data that helps companies avoid running out of stock and reduce waste.
• Batch Tracking and Traceability: Traceability is a crucial factor in the pharmaceutical industry. MES plays a role in tracking raw materials, intermediates, and final products during the production process. The system not only assists with recalls but also ensures compliance with regulations.
• Improved Quality Control/Management: MES plays an important role in ensuring real-time quality control. These systems constantly monitor parameters to identify any deviations and automate quality testing procedures. By doing so, they effectively minimize the chances of human error and contamination. MES enable the monitoring of manufacturing processes in real time, which helps promptly detect any deviations from standard operating procedures. This ensures that problems are identified and resolved before they escalate into issues leading to enhanced product quality. Moreover, MES has the capability to track and record data at each stage of the manufacturing process, creating a batch history. This feature facilitates effortless traceability and accountability, simplifying the identification of quality issues origins and enabling corrective measures to be taken.
• Resource Allocation: To improve productivity and minimize downtime, MES focuses on optimizing the allocation of resources such as equipment and personnel to ensure production scheduling.
• Real-Time Data Acquisition and Analysis: MES is responsible for gathering and examining data from production stages, enabling continuous improvement and process optimization. One practical application of MES is its ability to track equipment performance. It can keep an eye on equipment usage and notify operators when maintenance is required, thereby minimizing downtime and boosting productivity.

Taken all together, using MES results in increased efficiency (minimizing waste, boosting productivity, and identifying bottlenecks and inefficiencies) and reduces the chances of regulatory noncompliance.

Deploying MES: On-Premise, On-Cloud, or Hybrid?

On-site deployment refers to the installation of a MES software on your company’s servers. This gives your company control over the system and its data, allowing you to customize it according to your specific requirements. On-site deployment is often favored by companies with security needs or limited internet connectivity.

Cloud-based deployment involves hosting the MES on a cloud infrastructure. With this approach, the system can be accessed with an internet connection, making it highly flexible for manufacturers with multiple locations or remote workers. One key advantage of cloud-based deployment is that it eliminates the need for on-site hardware and software, reducing costs and ongoing maintenance expenses.

The bio/pharmaceutical industry is experiencing a rise in digital transformation, leading to the highest growth of implementation of MES in the form of hybrid MES. Hybrid deployment combines elements of both on-site and cloud-based modes. Certain components of the MES are installed on-site, while others are hosted in the cloud. The hybrid approach offers flexibility, scalability, and cost effectiveness as manufacturers can choose which components to deploy either on-site or in the cloud based on specific needs.

MES Applications In Bio/Pharma Manufacturing

There are three components in MES: monitoring, production control, and production documentation. Monitoring is responsible for ensuring that all processes are running smoothly and within parameters. Production control manages the flow of materials, resources, and personnel to optimize efficiency. Production documentation records all activities and data related to production for compliance purposes.

The monitoring aspect of MES plays a role in guaranteeing the quality and safety of drug products. It is projected to experience the highest growth of MES usage amongst the three components. This segment involves real time-monitoring of production processes, equipment, and environmental conditions to detect any issues that could affect product quality or compliance. A notable example illustrating the importance of monitoring lies in vaccine production. Vaccines must be manufactured under specific conditions such as temperature and humidity levels. Failure to maintain these conditions could lead to decreased efficacy and could even render the vaccine unsafe for use. Real-time monitoring helps ensure that vaccines are produced under conditions that minimize the risk of product failure.

Factors To Consider In Your Decision

One of the hurdles that pharmaceutical manufacturers encounter when adopting MES is the financial cost. Startups and other companies operating on tight budgets may find it challenging to allocate budget resources for it. However, the advantages offered by MES can ultimately outweigh the expenses as it has the potential to enhance efficiency and elevate quality.

Another obstacle lies in the complexity associated with implementing MES. It necessitates planning and coordination among various departments. To successfully integrate MES, organizations must possess an understanding of their operational procedures and workflows. Furthermore, selecting a MES solution tailored to your specific requirements (i.e., being strategic about your MES selection) is crucial.

MES Are Being Implemented In Which Regions?

Pharmas and biotechs in North America are surging as the frontrunners of MES use as companies aim to increase automation and reduce operational costs. Implementation of regulations and industry standards in this region has further accelerated the adoption of MES solutions as pharmaceutical companies prioritize compliance.

Pharmas and biotechs in Asia Pacific, particularly companies based in China and India, are showing increasing adoption of MES as the need for increased quality control grows. India particularly continues to strengthen its ecosystem for manufacturers within the country. Furthermore, the pharmaceutical industry in India is actively exploring ways to streamline their manufacturing processes in response to the expanding pharmaceutical sector within the country, which is projected to hit $132 billion in market value by 2030.

Key Players And Recent Collaborations

The prominent vendors in the market include Epicor Software Corporation, Siemens AG, Rockwell Automation, Inc., SAP SE, ABB Ltd, Dassault Systèmes S.A., AVEVA Group Plc, Applied Materials Inc., Oracle Corporation, General Electric Company, and Emerson Electric Co. Some recent notable partnerships include:

• In March 2021, Lonza and NNIT formed a collaboration to expedite MES projects. This partnership aims to merge Lonza’s MODA Platform with NNIT’s implementation methodology. By doing this, the companies will be able to attain a comprehensive Pharma 4.0 solution and realize their digitalization goals more swiftly than ever before.
• In May 2022, Eyelit, a company that specializes in MES, quality management systems (QMS), and factory automation solutions, announced its acquisition of MESTEC, a U.K.-based vendor offering manufacturing Software as a Service (SaaS). This partnership between the two customer-focused solutions providers will enable Eyelit to offer a range of manufacturing software solutions to various industries.
• In September 2022, Siemens Digital Industries Software entered into an original equipment manufacturer (OEM) partnership with Cybord. Through this collaboration, Siemens will be able to incorporate Cybord’s analytics and automation software into its product portfolio. As a result, customers will gain access to tools that can optimize production processes and enhance overall efficiency.

Conclusion

The MES market is expected to grow from $13 billion in 2022 to more than $33.5 billion by the end of 2035 with a projected compound annual growth rate (CAGR) of approximately 11%. This growth is primarily fueled by the rising demand for process optimization and automation. In an industry where safety and effectiveness are crucial, MES has become an essential tool for streamlining production processes, cutting expenses, and expediting the time it takes to bring medications to market.

About The Author:

Aashi Mishra is a content developer at Research Nester and is also an electronics engineer. She has three years of market research experience.