It was a most unusual road trip - Drivers on the highways of Europe were probably surprised to see the scaled-down equivalent of a bioprocessing production line rolling next to them last year. In 2010, Merck Millipore launched its Biosafety Tour, a travelling exhibition and technical seminar tour designed to provide customers with answers to their unmet biosafety challenges, directly at their facilities. The truck visited 23 cities throughout the Netherlands, Belgium, UK, Germany, France, Austria and Switzerland and gave visitors a hands-on look at Merck Millipore's single-use technology. Brandi Schuster spoke with Michael Weber, regional sales manager Germany/Denmark for biopharm process solutions at Merck Millipore, about the lessons learned from the tour and new trends in bioprocessing.

CHEManager Europe: Mr. Weber, the European Biosafety Tour sounds like it was an epic undertaking. What was the reason for it?

M. Weber: By meeting biotech and pharmaceutical manufacturers face-to-face, we wanted to help solve their greatest biosafety challenges. Since most in the industry are pressed for time, a truck that physically showed our capabilities and innovations - from the bioreactor to sterile filtration all the way down to final fill steps - was highly appreciated by our customers. We were able to show them how we can help with challenges on new projects - from process development to clinical production using single-use technologies.

What kinds of trends are you seeing in bioprocessing?

M. Weber: Our customers have been achieving higher titers, particularly for monoclonal antibodies - mAbs - for some time now. These higher titers allow them to consider using smaller bioreactors. This, over the last several years has resulted in a push to the use of single-use technologies in bioprocessing - not just the bioreactor, but the purification process as well, on order to enhance production flexibility. The Merck Millipore truck showed a completely disposable way of producing monoclonal antibodies. That means for every single step involved, everything was disposable.

How does the use of disposables make production more flexible?

M. Weber: First and foremost, there is no cleaning necessary between batches, which makes production time much shorter. It can also save money - the investment in disposables can be lower than in stainless steel.

One other important reason for the increased interest in single-use technologies is the ability to delay investment decisions. It takes significantly less time to go from plan to qualification with a single-use facility when compared to a fixed/stainless steel facility. This enables some of our customers that are waiting for clinical trial results to defer large investment decisions. While stainless steel still has its place in production, it's much more cumbersome to use if a manufacturer often changes production from one product to another. In the case of stainless steel, all of the equipment must be properly cleaned and validated and sometimes a company even needs dedicated equipment for a particular product.

With the Merck Millipore Mobius FlexReady solution, users can install equipment, configure applications and validate their processes quickly and easily, significantly shortening development, validation and manufacturing time. It can simply be taken off the shelf and it's ready to go - the pump is there, as well as pressure sensors, valves, etc. If the user wants to then start production on a different product, they only need to dispose the used flowpath or Flexware assembly put the previous one away, put a new Flexware assembly in place and then they can get going. That means there's no sterilization involved and no need for cleaning.

In terms of flexibility, are companies are trying to do different kinds of processes at the same time? Are they doing smaller batch runs?

M. Weber: This is very often the case for the contract manufacturers and researchers used by the big industry players. They simply must be able to work flexibly and quickly. They need to be able to go through an entire process in a short period of time, and they need to be able to change from one product to another.

While the time-saving advantages are obvious, it sounds like the use of disposable equipment can get relatively expensive over time, whereas stainless steel is more or less a one-time investment.

M. Weber: As mentioned before, the disposable solution doesn't fit everywhere. The investment and the running costs of a process have to be calculated for both solutions and customer needs to make a decision. This isn't an easy task as you also have to consider the costs of working time, water, cleaning chemicals, waste, etc. Merck-Millipore has experienced specialists who can do a full-cost calculation with our customers in order to assess what would be their best solution - disposable or stainless steel.

Is there a demand for more and more components to become disposable?

M. Weber: Yes. We are currently developing disposable sensors that measure things such as pH or conductivity. Of course, when the assembly is disposable, only a certain price is acceptable. This is certainly a challenge we are currently working on.

What about the recyclability of these disposable components?

M. Weber: Sustainability is for us a big topic, and we are doing a lot of things in this direction. For example, we started in an early phase with contracts with some of our customers to recycle our cartridges after production. But as the Flexware assemblies are often used for monoclonal antibodies, they are not allowed to be recycled. Therefore the used single-use components are generally incinerated
We were asked a lot on the tour about the sustainability of using disposable equipment. However, when we consider that stainless steel has to be cleaned and sterilized after each use, which consumes an incredible amount of energy, water and cleaning solutions, it is not very easy to handle in terms of sustainability.

So does it come out being around about the same or is there really a sustainability advantage to having disposable?

M. Weber: It depends, which is why we first work to figure out what's best for the customer's particular production line. For example, if a company has a production line producing the same product every day over years, then it makes absolutely no sense to use disposables. However, if they are frequently switching between products, then it makes perfect sense. While there is a general perception that there is more waste with single-use equipment, detailed analysis has shown that the overall carbon footprint with single-use is comparable or smaller than the carbon footprint in an equivalent stainless steel production facility. The perception exists because the use of single-use technologies generate more visible waste while the predominant waste in a fixed/stainless steel facility is water (lots of it) and cleaning chemicals.

What kind of scale up can be done with disposables?

M. Weber: The largest bag we've sold was 3,500l, but that was really an exception. Normal would be up to 1000-2000l. This is a range that can be handled well with disposables. We have mixers that start at 10l and go all the way up to 500l; and also a 1,000l disposable mixer will be launched this year.

It should be mentioned that almost one year has passed since Merck bough Millipore in July 2010. How did that affect the company in terms of innovation?

M. Weber: In terms of all the new products like the Mobius FlexReady solution, I am sure the innovation we did as Millipore was really outstanding, and now it is even easier with Merck. Now we've been able to combine the capabilities from both companies in order to find the best solution for our customers.