Single Use – Your Way

Single-use systems are well established in the industry. The first single-use technologies to emerge were very simple; for example, single-use tanks and mixers. In time, the first single-use bioreactor was launched (the WAVE bioreactor) and stirred bioreactors are commonplace today. Now, we are also seeing increasing uptake of more complex, sophisticated single-use systems, such as chromatography and final-fill systems. Many vendors are actively innovating in this area – including Millipore Sigma.

The advantages of single use are well known – especially, ease of use. Pre-packed columns and ready-to-use filtration assemblies have made a huge difference to many companies’ bioprocessing operations because they are so easy and fast to set up; single-use parts are pre-eradiated, sterilized, and ready to use as soon as they are removed from the packaging. With stainless steel, on the other hand, end users have to clean new equipment and validate its cleanliness before use – and cleaning continues to be needed throughout the equipment’s lifecycle. Cleaning is expensive in terms of utilities and labor costs, but perhaps more significant is the time lost. If you are running 40 campaigns a year using stainless steel, I’d wager you could increase this to perhaps 50 campaigns or more using single-use systems and components.

Single-use systems certainly have many benefits, but there are still industry concerns regarding their use. First of all, there is the hot topic of extractables and leachables that may affect the drug product. The BioPhorum Operations Group has been instrumental in considering these challenges, and stresses the importance of understanding the extractables profile. As a supplier, we are obligated to provide information about extractables and leachables upfront, and to demonstrate that there are very low levels of extractables (if any) leaving the plastics that we select and use in our processing. A second concern is breakage. Vendors must work with end users to help minimize breakage risks. We do a lot of user handling training, for example, and we are always looking for more robust materials to use for our products. Single-use assemblies are complex and can be fragile – they need to be handled carefully.

Pick and mix

There are also industry concerns around supply. Rather than the biopharma manufacturer controlling the inventory of their fluid management systems, this role passes to the vendor – and the end user is dependent on the vendor for ongoing supply. Some companies fear this loss of control and it certainly places a tremendous responsibility on the vendor. With demand for single-use systems increasing, vendors have to carefully consider their capabilities and their capacity to service customers in a reasonable amount of time. In some cases, lead times can be a real problem for biopharma manufacturers.

With this in mind, we launched the Mobius MyWay portfolio in March 2017. The concept is based on partnering with our end users to offer better supply predictability and to ensure that assemblies are ready when needed. The portfolio is divided into three categories:

• Mobius Stock. Some customers need single-use assemblies immediately and want to order them off the shelf as a standard part. Mobius Stock offers on-demand solutions for certain popular components – and these are ready to ship in 24 hours. We also offer stocking agreements if a company buys enough assemblies annually, where we prebuild and stock items that the customer can order at will.
  
• Mobius Select. This is a balance of speed and configurability of custom assemblies. Customers can pick and choose the components they need for a custom assembly (even complex assemblies) from an optimized pool of parts (around 300 components) – and this is delivered with a six-week lead time. Traditionally, lead times for custom assemblies in the industry are around 13 weeks. Most companies will find what they need in this category – around 90 percent of the assemblies we supply are made with Select components. 
  
• Mobius Choice. Here, we design exactly what the user wants, including made-to-order parts, but orders are shipped in standard lead times.

With the MyWay program, many users mix and match between Stock and Select, which encompass the most in-demand parts – and we hope this will provide clarity around lead times, while getting components and assemblies to users as fast as we can. We aren’t the first company to try a new approach to stock and delivery, but vendors tend to target standard assemblies with standard configurations. However, there is still a lot of specialized processing and customization in the industry too, so some customization, whether in tubing size or materials, is usually required. We believe it is important to supply exactly what customers want, and to offer them the ability to pick and choose – and the Choice category is crucial for those manufacturers that need very specific parts – but obviously extensive customization comes with different lead times to Stock and Select. The whole program is about being able to deliver parts accurately so that users can plan better. For us as a company, it’s also about preparing for the future growth of single use too – 10 years from now, we want to be able to supply to the customer on an as-needed basis.

Supply and Support

As uptake of single use in the industry continues to grow, more industry discussions are taking place about standardization. I expect to see greater standardization in the future, but it will perhaps be the 80-20 rule – with 80 percent being standardized and 20 percent being custom. Bags sizes, for example, are a logical choice for standardization, but at the end of the day there will always be a need for custom solutions in the pharma industry.

I feel very strongly that single use will continue to grow. Today, single use is predominantly used in clinical manufacturing – around 30-40 percent of clinical drugs are processed with single use. For commercial manufacturing, it’s around 20 percent, but this number will increase. In 10 years, it could be well over 50 percent for clinical drugs and 40 percent for a commercial drug – and Mobius MyWay will enable us a supplier to better respond to this increased demand. When a new drug is about to launch, manufacturers are increasingly looking at single use because of ease of use, flexibility – and because it avoids the need to invest in stainless steel infrastructure. Documentation also comes with our systems so users have everything they need to start getting approval in major markets.

Our role as a supplier has expanded away from simply supplying systems to also providing extensive support around single use to help customers get started. Our Mobius MyWay portfolio makes the supplier-customer relationship even more intimate – we discuss the customer’s assembly needs, and whether certain parts can be tweaked to offer a six-week lead time rather than a 13-week lead time. It’s all about collaborating to make sure our customers are able to begin processing faster.

Karen Green is Senior Product Manager at Millipore Sigma.