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.