Seamless scaling: The role of smart automation in CGT manufacturing

Cell and gene therapy teams face unique challenges in scaling production while maintaining precision and compliance. Strategic automation enables seamless technology transfer, integration, and scalability—turning solutions to reduce complexity into a competitive advantage.

Advanced therapeutics is one of the fastest growing areas in life sciences. Many of today’s most promising new treatments are cell and gene therapies. As the landscape evolves, it is populated both by small startup pioneers exploring groundbreaking new techniques, as well as established pharmaceutical manufacturers looking to expand their portfolios. 

Much of the change comes from a shift in the paradigm of treatment delivery. Today’s organizations are far more focused on identifying the specific needs of individual patients, evidenced by a shift from development of blockbuster treatments to more targeted therapeutic research over the last decade. 

Cell and gene therapy takes that step to an even more granular level—if a life sciences company can better understand a patient’s or patient population’s genetics, the organization can better develop treatments that fit the needs of those patients. Moreover, they can also more efficiently and effectively tweak those solutions over time to continue delivering the best treatments possible.

As more organizations explore cell and gene therapies, they are discovering that production in this field requires new strategies. Flexibility, integration, and seamless technology transfer and scalability are all critical differentiators for success, but also particularly complex to capture at the small scale of most cell and gene therapy operations. Automation is often the solution, but teams must be strategic in the way they pursue an automation strategy.

Change creates challenges

At the heart of the challenge is the fact that cell and gene therapy development processes are often continually in a state of change. Teams are constantly adjusting processes, as well as adding software and equipment to improve operations. 

For example, as a process evolves and moves through commercialization, the team might require a library information management system, process knowledge management (PKM) software, quality systems, a manufacturing execution system, and more. For each solution, there will be many options from a wide variety of suppliers. However, if the selection is not made thoughtfully, teams can quickly end up with operators needing to navigate several disparate systems, jumping back and forth among them.

Moreover, if teams do not plan well, data management can quickly become a problem. In the earliest phases of development, scientists need to make changes to the process very quickly. As the team adjusts recipes and processes, they will need to track those changes. 

Today, much of that recording is done manually, often on electronic spreadsheets or electronic notebooks, but sometimes even on paper. Manually tracking adjustments, even on these electronic systems, is not only time consuming, but also prone to error. 

Equipment changes also add to the complexity of cell and gene therapies. If one chromatography step does not perform adequately for a particular process, fixing the problem is rarely as simple as pulling that column out and replacing it with a new one. Often, the team will need to go back and rebuild the process around the specifications and connectivity requirements of the new equipment. 

Setbacks at scale

As with any innovation, most new cell and gene therapy treatments start small as their developers work out the processes and procedures necessary to deliver the best product possible. A small cell and gene therapy site might have one bioreactor today, but the plan is never to operate that single bioreactor forever. Upon proof of concept, the team will want to scale up to bring effective treatments to more people. Accomplishing that scalability easily and cost effectively requires planning for it from the earliest stages (Figure 1).

A key element to unlocking scalability and speed to market is flexible operations. From the earliest stages, teams should design automation into their processes to reduce errors, allow for fast and seamless changes, and promote simpler operation and iteration across development. The worst-case scenario is developing a process designed around equipment and software that must be scrapped and rebuilt upon scaling because it cannot operate at that scale, whether scaling up or out. However, even if the team can create a scaled solution via complex engineering, such a configuration will create challenges of its own.

Planning for the future

Fortunately, modern technologies are helping cell and gene therapy teams take a born digital approach to futureproof their processes. Emerging methodologies are making it possible for teams to swap equipment in and out of their processes more easily as changes become necessary. By selecting solutions that support these flexible technologies from the earliest stages, teams are dramatically simplifying their adjustments and building more modular processes.

In addition, many teams are exploring software solutions like PKM software to help them manage their data end-to-end across the development pipeline. The right PKM solution helps ensure continuity, consistency, quality, and security of data at every stage, not only making it easier to move across the technology transfer process, but also providing support in late stages where auditing earlier steps in development may be necessary (Figure 2).

 

Building for purpose

There are many new technologies that cell and gene therapy teams are employing as part of their automation strategy to simplify and streamline development and operation. However, the most effective teams are upleveling that process with a born-digital strategy designed to lock in intuitive operations and seamless integration from the earliest stages. 

These organizations are requiring automation solutions providers to help them build future-proofed systems through delivery of natively integrated solutions that simplify operation and are built around the key technologies necessary to unlock modularity and flexibility. It is possible to find solutions that promote simplicity rather than complexity—if teams plan for those strategies from the earliest stages of development.

All figures courtesy of Emerson

About the author

Kristel Biehler is vice president of life sciences for Emerson’s process systems and solutions business where she leads the day-to-day business activities in sales, operations, and technology that serve the life science industries. In her previous role at Emerson, she was the automation solutions vice president of sales for the western United States where she led teams that helped customers identify, architect, and implement automation and digital strategies across a wide range of industries. Kristel Biehler started her career with Emerson in 1998. She holds a bachelor’s degree in mechanical engineering from the University of Utah. Prior to Emerson, she worked for Sorex Medical as an automation engineer.