Single-Use That’s Ready When You Are

Sara Bell is fortunate to have been on both sides of the fence, spending 11 years in operations at Amgen before joining Merck KGaA, where she is now Senior Marketing Manager of their single-use portfolio. Sara knows full well the challenges faced in biopharma manufacturing – and why single-use is seeing increased uptake. Here, we talk to Sara about trends in single-use systems and why supply security of these products is critical to drug manufacturers.

What are the pros of single-use?

I would highlight four key benefits. The first is flexibility, which is really beneficial to multi-product facilities and contract manufacturing organizations (CMOs) that need to produce a variety of different products at different scales. Demand for those products can change rapidly, so being able to adapt quickly – which single-use allows – is a huge advantage. Secondly, single-use helps lower costs by reducing plant footprints and upfront capital spend. For emerging markets looking to get into the biopharmaceutical market, single-use is a great option because it requires less investment than a traditional stainless steel plant. The third benefit is speed. It’s often faster to get a product to market using single-use. There is no need for clean-in-place or steam-in-place, and no need for validation of these operations, which greatly reduces the time it takes to get a facility up and running. Finally, single-use reduces your risk profile in terms of contamination. As the name suggests, once you use the product you throw it away and install a brand new sterilized assembly, so the risk of product carry-over is completely eliminated. In addition, due to the closed nature of single-use, you have better biological and viral contamination control.

And the cons?

There are risks and considerations to evaluate when implementing single-use, but I firmly believe that the benefits outweigh the risks. So, what is keeping drug manufacturers up at night when it comes to single-use? One of their biggest concerns is supply security. With traditional stainless steel manufacturing, the amount of consumables needed to run a process is limited to cell culture media, process chemicals, resins and filter elements. Additionally, production plans are primarily driven by turn-around time, or the time it takes to clean and sterilize vessels between batches. With single-use, the amount of consumables needed to run the process significantly increases, which makes the supply chain, especially procurement and inventory management, much more complex.

Many single-use suppliers use proprietary components, such as films, connectors and tubing – as well as their own technologies and assemblies for bioreactors, mixers and automated systems. Such non-uniformity means that it can be very challenging for end-users to dual source the consumables needed to run their processes. Therefore, they are forced to manage the risk by holding large quantities of safety stock, or performing tests to justify that two different products are “like for like”. Varying supplier lead times and delivery delays can also impact production plans. These are challenges that we have sought to address through the Mobius® MyWay program.

What’s the story behind the Mobius® MyWay Program?

The single-use market has seen significant growth over the past 10 years, and is predicted to continue to grow at a double-digit rate through 2025. Like many other single-use suppliers, we began to run into capacity challenges and it was important for us to define a scalable manufacturing model that met or exceeded end user expectations in terms of lead times, delivery, quality and supply security. The Mobius® MyWay program, which launched in January 2017, came into being to meet those end user expectations. Essentially, the program offers three options for customized single-use assemblies.

The first option is Mobius® Stock, which covers catalog items and high-volume repeat custom assemblies. With this option, we maintain stock of the assembly part number on our shelf and deliver when needed, which allows end users to maintain less inventory. Option two, Mobius® Select, allows end users to design configured assemblies from an optimized component library, and receive them within six weeks. We maintain safety stock of every component in this library, thus enabling fast and reliable delivery with an enhanced level of supply security. The third option is Mobius® Choice, which allows end users to design customized single-use assemblies using our full Mobius® component library, and receive them with a traditional lead-time of 12–14 weeks.

Many single-use suppliers have chosen to address capacity challenges and custom business complexities using a different approach, by defining pre-configured standard assemblies. They offer solutions that they think end users will want. From our experience, no matter what you expect the end user to want, they will always want something slightly different! The Mobius® MyWay Program allows end users the flexibility to design a custom assembly and decide when they want to receive it.

Mobius^® Select has been particularly popular…

Yes – and for good reason I think. If you look at the global market today, there are many dynamics impacting the biopharma industry. To remain competitive, drug manufacturers must examine how to cut costs, as well as how to increase flexibility and productivity. Biosimilars, emerging markets, novel therapies and next generation processing are just a few of the variables driving greater adoption of single-use. Many users are designing customized assemblies, using different components, from a variety of suppliers. It’s gotten quite complex for end user networks to manage, so many are now looking to standardize and harmonize their single-use assemblies, by defining a set of preferred components – essentially a design space that they use to develop new assemblies. The Mobius® Select library provides them with just that; an optimized design space of pre-qualified components backed with supporting quality documentation and a growing dataset of extractables, tested per the BioPhorum Operations Group (BPOG) protocol. This significantly reduces the amount of testing required by the end user, and enables them to implement single-use faster. The six-week lead time allows end-users to hold less inventory and be more nimble with their production planning. And the biggest benefit with Mobius® Select is that it still gives end users the flexibility to customize their assembly, across a broad range of applications, to meet their specific processing needs and requirements.

How has the industry reacted to the new offering?

We saw adoption pick up significantly mid-2017. We find that once an end user experiences the entire process from the design of their assembly through to order receipt, they realize the value that Mobius® Select can provide – not only in terms of delivery time, but also in terms of quality assurance, reduced inventory costs, time savings, flexibility, and security of supply. These benefits drive the creation of new Mobius® Select assemblies and have also prompted end users to reach out to us with specific requests; for example, “I have X number of existing assemblies from Merck KGaA or a competitor. Can you help me transition these to a Mobius® Select design? What components would I need to tweak to make this Mobius® Select compliant?” For common applications like mixing, storage, transfer and filtration, typically only minor component or tubing length changes are needed to make a design Mobius® Select compliant.

The program has proved to be very successful for both us and end users. The aim of the Mobius® MyWay Program was to meet drug manufacturers needs in terms of fast and reliable delivery, easing the implementation of single-use, and increasing the level of quality and documentation that they receive with the product. But the solution we came up with also enabled us to scale our manufacturing operations to ensure we can support the continuing growth of single-use through 2025 and beyond.

We are going to continue to enhance the program and evolve the library based on market needs. Towards the end of November, we are launching a web-based interactive tool that will allow end users to see which components are available in the Mobius® Select library. For more information on the program, or to request the help of a  single-use specialist, I encourage readers to visit merckmillipore.com/singleuse-myway. To directly link to the Mobius® Select tool, you may visit www.mobiustool.com.