As the CGT market evolves, developers must answer one key question that will shape their manufacturing strategy: “Should we go with a modular platform or a fully integrated system?” 

Both approaches have their benefits and considerations. And the decision you make has profound downstream effects — on scalability, on cost efficiency, and on the ultimate commercial feasibility of the program.  

This blog post will help you weigh the pros and cons of both approaches so you can decide which one better suits your needs. Plus, you’ll gain insight into how to execute each strategy successfully and the steps you can take today to lay the foundation for your program’s long-term success.  

Fully integrated systems provide rapid uptime — with limits for some use cases 

Fully integrated systems are turnkey solutions: They’re single devices that serve as a one-stop shop to complete manufacturing.  

Using a single device offers significant benefits, especially for developers manufacturing therapeutics in small batches.  

Fully integrated systems allow developers to realize rapid time-to-value, because they can skip the cost — and delay — of building a custom solution. A fully integrated solution also requires fewer transfers between devices during manufacturing, resulting in simplified workflows and less hands-on time — which means fully integrated systems are less prone to human error or contamination. Finally, working from a single device makes it easy to transfer manufacturing data into the digital backbone of the program, which improves data integrity and reduces the potential for human error.  

But the rapid uptime of a turnkey solution comes at a cost — and fully integrated solutions trade flexibility for a more simplified workflow.  

Developers may be limited to reagents manufactured by the device vendor, with reduced/lower compatibility for third-party reagents. This introduces manufacturing risk since developers may not be able to source backup suppliers for critical reagents and may not be able to complete workflows that rely on third-party reagents. Plus, users have less control over device parameters, which means manufacturers must work with the customization available to them, rather than having full control over their processes.  

Finally, a fully integrated system means you’re limited to the capacity of the chamber size on the device. That means you may require several devices to scale production for autologous products and may not be able to manufacture allogeneic off-the-shelf products that produce multiple doses per batch. 

As a result, fully integrated systems are usually the best fit for developers that require less scalability — or those who need to launch manufacturing on a limited budget. While these systems may be less cost-efficient over time for developers who need to make several batches with long culture times, they allow developers to begin manufacturing without the up-front capital required to purchase several devices for a customized solution.  

A modular approach offers more customization, but it also requires more hands-on time 

On the other end of the spectrum is a fully customized approach — one that mixes and matches devices to create a platform tailored to the program’s needs.  

A modular approach allows users to customize each unit operation on each device, providing greater control with which to optimize process development. That flexibility pays off once developers begin manufacturing: By maximizing the use of each unit, developers can produce larger batches using fewer devices than with a fully integrated approach. This approach also helps manage long-term costs, since developers can address small cost inefficiencies that can accumulate into significantly higher production costs over time.  

In short, these solutions tend to be more scalable to larger batch sizes and allow developers to fine-tune their processes, enhancing the cost efficiency of the program overall. 

But, as you might expect, a modular solution requires significant resources to set up. To reap the full benefits of modularity, developers must have access to experts in process development and manufacturing to optimize each device for the program’s needs, as well as time for the team to hone each workflow before manufacturing begins.    

Modular systems are also capital-intensive since developers must purchase several devices — such as a cell-separation device, a bioreactor for culture and a cell wash/formulation device — that may have a larger footprint than a single fully integrated device. Developers also need to cover ongoing maintenance costs, as well as invest in labor to transfer materials between each device while minimizing the risk of contamination.  

How to select the right platform for your program 

Now that you understand the strengths and weaknesses of fully integrated vs. modular approaches, you’ll need to consider the unique needs of your program to find the best approach.  

Key considerations should include: 

• Cell characteristics (e.g., cell type, cell number and cell health) 

• Scalability 

• Flexibility 

• Uptime/time-to-value 

• Additional resource requirements (e.g., trained personnel, footprint, capital for equipment) 

Fully integrated systems may be the best fit for manufacturing autologous products with low cell culture volumes and programs that require minimal product ramp-up.  

Since manufacturers will never need to significantly scale capacity for these therapeutics, the bottlenecks — and costs — associated with scaling all-in-one platforms become less of a concern. Choosing a fully integrated platform allows developers to save money up front by investing in a single device and reap the benefits of rapid time-to-value.  

Modular systems, on the other hand, may be best for allogeneic products with large culture volumes, as well as autologous programs that require scale-up and scale-out at later phases of development.  

While they may cost more up front, the ability to maximize cost efficiency over time can lead to greater savings overall. Developers should also consider modular systems for programs that require finer control over the process parameters or have bespoke reagents/consumables that fully integrated devices cannot accommodate.  

The importance of automation 

Whether you opt for a fully integrated or a modular platform, look for opportunities to incorporate automation into your workflows. Automation helps reduce the need for manual intervention, allowing developers to scale manufacturing with a leaner head count, as well as minimize the risk of human error and contamination.  

Newer fully integrated platforms can leverage automation for parallel processing of several products at once — a potential game changer for autologous products since they reduce labor while also boosting throughput.  

Modular systems can also incorporate automation to boost efficiency. Robotic transfers between unit operations to minimize reliance on labor, helping to reduce the risk of human error and increase production throughput. And, since modular systems allow for more optimization than turnkey solutions, an automated modular system offers the greatest cost efficiency at high volumes.  

Start planning early to streamline manufacturing 

No matter which platform you select, deciding early can help you streamline the transition from process development into manufacturing. A deep understanding of your long-term needs allows you to forecast the cost efficiency of each platform over time, allowing you to determine if the cost efficiency of a modular system can offset a higher up-front capital cost, for example. Alternatively, you may learn that the up-front savings of a fully integrated platform minimizes costs over time, despite slight inefficiencies due to limited flexibility along the workflow. 

We’re here to help you devise a manufacturing strategy that works 

Selecting a platform is an important decision — and it’s one you don’t have to make alone. Catalent’s deep bench of CGT manufacturing expertise can help you consider the cost, hands-on time, and scalability of different solutions, helping you ensure product viability throughout manufacturing and commercialization.  

Learn how we can help you optimize your manufacturing strategy.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers’ needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.