Picking the right MES or automation solution for a life sciences application

MES and automation insights

• The life sciences industry is undergoing a transformative shift and as a result, automation adaptability is crucial for large-scale traditional manufacturers and smaller, agile players.
• Comprehensive manufacturing execution systems (MES) with native DCS integration can help streamline processes, reducing errors and enhancing operational efficiency for larger facilities.
• Manufacturers in personalized medicine often use software-as-a-service (SaaS)-based solutions, emphasizing simplicity and scalability for improved digitization without extensive coding expertise.

The life sciences industry has evolved over the last decade. Emerging scientific discoveries have led to advancements in therapeutics for targeting specific diseases once considered difficult or impossible to treat. Personalized medicine, including cell and gene therapies, has emerged alongside traditional population-targeted medications that have been a treatment staple for decades.

These changes have introduced many new players in the market, all of whom operate very differently from traditional manufacturers. Often, these manufacturers start small, and they rapidly iterate manufacturing processes to deliver novel products quickly and consistently. As a result, there is an increasing need for life sciences manufacturers to stay flexible and nimble. This requirement, as a result, is changing the way many manufacturers approach automation.

The need for large-scale production of traditional therapies has not gone away, nor have the manufacturers making them stagnated. Supply chain issues during the global pandemic made it clear that safe speed-to-market is of the utmost importance for the large-scale manufacturers producing the world’s most critical treatments. Though their approach to automation is more traditional, it is no less important as they strive to shepherd hundreds or thousands of batches quickly and safely through the quality review process.

Because the spectrum of treatment manufacturing types is now so broad, life sciences companies are discovering that a one-size-fits-all approach to automation and operations management is no longer appropriate. Fortunately, today’s forward-thinking automation suppliers offer a range of options to help companies implement automation solutions aligned with their needs. Selecting the right automation technology requires understanding each manufacturer’s unique operations management needs and then aligning those needs to the best technological solutions to help the manufacturer optimize product delivery, quality, safety, and cost.

Comprehensive MES solutions for reliable repeatability

In traditional manufacturing of population-targeted treatments, operations trend toward making the same product many times, with limited to no process changes. The process is often well established and the goal of getting treatments into the hands of patients as quickly and safely as possible is transparent. These large manufacturers are often producing batches of the same therapy hundreds of times per year.

These types of companies typically turn to a manufacturing execution system (MES) that is integrated with a distributed control system (DCS) to orchestrate and document batch process activities. This automated, closed-loop control of a full-scale MES reduces the potential for errors in operation by eliminating as many manual activities as possible.

The most advanced systems — those with native DCS integration — can instantiate a batch on the DCS, while maintaining all batch characteristics and critical parameters, all without any operator intervention, reducing the risk of human error. When the MES is integrated and validated, the operator does not need to manually enter or verify individual control parameters, thereby reducing opportunities for errors and increasing operational efficiency. The batch simply shows up on the operator interface, ready to run.

The system is automated from end-to-end, and batch record review can be simplified to only require examination of exceptions that were recorded during the process. When manufacturers leverage review by exception, they eliminate the time spent inspecting batch records, instead focusing only on the areas where the pre-validated process deviated from normal (Figure 1).

Figure 1: Manufacturing execution systems, like Emerson’s Syncade MES, offer granular control to help manufacturers design closed-loop automation for batch processing. Courtesy: Emerson

Streamlined SaaS solutions for nimble operations

In contrast to large batch facilities, there is still a great deal of human involvement in operations in cell and gene therapy and process development spaces due to smaller production scales and rapid process optimizations.

Moreover, many of the manufacturers operating in the personalized medicine space, such as those making advanced therapy medicinal products, are small companies with limited resources to implement and support automation technologies. Often, these manufacturers do not have a deep bench of information technology experts, nor a wide array of staff experienced in the coding necessary to configure and maintain a full-scale MES.

However, these small, nimble manufacturers still need automation features — such as enforced sequence of operations, segregation of duties, and robust data integrity — to help ensure good manufacturing practices (GMP) are followed. Consequently, these manufacturers tend to opt for paper-based documentation, or for simplified recipe authoring and execution solutions delivered as software-as-a-service (SaaS). Such solutions are a simple and scalable way to accelerate digitization and improve product lead-time and quality, without the need for personnel to have coding expertise to support the system. These solutions typically do not support integration with automated process control systems.

With the best solutions, users leverage drag-and-drop recipe authoring elements to create the steps for a new recipe and automate workflows. These drag-and-drop elements are predesigned to conform with GMP standards, enabling teams to add new parameters and e-signature requirements to drive quality control, ensure regulatory compliance, and automatically generate reliable batch records (Figure 2).

Figure 2: Software-as-a-service solutions, like Emerson’s DeltaV Workflow Management, empower operators to quickly create recipe authoring workflows without any coding or IT expertise. Courtesy: Emerson

Starting from the right foundation

A right-sized automation solution exists for any life sciences manufacturer, regardless of its operations. To make the right decision, manufacturers should first evaluate their needs to identify whether a full-scale MES solution or a paper-on-glass recipe authoring solution best fits their operations, expertise, and budget. Once that decision has been made, teams can explore their many options, prioritizing systems that are feature-rich, and designed for seamless integration and scalability. This approach will ensure their automation systems serve their needs over the entire product lifecycle, even as they scale and their needs continue to change.

Christian Berg is an enterprise solutions architect consultant for Emerson. Edited by Chris Vavra, senior editor, WTWH Media LLC, cvavra@wtwhmedia.com.

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Keywords: industrial networks, manufacturing execution system (MES)

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