Milestone Bioprocess Technology
Exclusive Interview: Milestone Bioprocess Technology The Ideal Solution for Every Application
From filter supplier to full-service provider — Since taking the groundbreaking decision around 25 years ago to concentrate on the biopharmaceutical industry, Sartorius has seen a rapid rise in its fortunes. In conversation with us, Bettina Berendsen and Fritjof Linz explain the significance of single-use technology and report on the latest developments within the company and across the industry as a whole.
PROCESS: In its celebration year of 2020, Sartorius has created a new brand image with a new claim. What exactly does “Simplifying Progress” stand for?
Bettina Berendsen: Sartorius has undergone tremendous change in recent years, particularly with regard to our contribution to the development and production of advanced biopharmaceuticals. What we would like to express with our new claim is that we aim to simplify and accelerate our customers’ processes with our technologies and products. By doing this, we strive to help make innovative, affordable drugs for the treatment of cancer and autoimmune diseases available more quickly.
PROCESS: Looking back at the early days of the Bioprocess Solutions Division, where were the roots of Sartorius?
Berendsen: Historically, of course, in the area of membrane filtration technology. Before we devoted ourselves completely to the entire bioprocess chain, we started out as a filter manufacturer with a limited portfolio of products. In the mid-90s, we took the decision to focus on the pharmaceutical and biotech industries. It was our vision that Sartorius should develop into a “Total Solutions Provider”. To do this, we analyzed the market and investigated where technology solutions were needed. We concentrated on key applications and started to successively widen our portfolio. This was done with in-house developments, but also through acquisitions, e.g. Braun Biotech International, Stedim or TAP Biosystems. The acquisition of cell culture and fermenter specialist B. Braun Biotech was a major first step in our development into a total solutions provider. From an early point, this also enabled us to offer solutions for upstream applications.
PROCESS: So was “single-use” not yet an issue at all at this time?
Berendsen: In those days, everyone was trying to use permanently installed tubing and connections for everything, and manual handling was frowned upon. All processes were heavily automated in order to keep error rates and risk of contamination from staff as low as possible. It is important to remember the incredibly low titers as well, which at the time were often still less than a gram. This is why huge fermenter volumes of up to 20,000 liters were required. There is no way this could have been done with single-use equipment.
PROCESS: What is the industry’s take on single-use now?
Berendsen: Market penetration is significantly higher, particularly in the USA and China. Here we are seeing production plants that are designed from the ground up for single-use equipment. Among other things, single-use technology also offers advantages in terms of time savings, since the commissioning of new systems can be left until later — i.e., until a point when the probability is actually extremely high that a candidate for an active ingredient will actually reach market maturity. By contrast, a lead time of several years is required for the production, installation and qualification of a stainless steel system — but it is important to consider that, even today, still around 50 percent of oncological antibodies fail at clinical phase 3, and to understand what this means regarding the potential investment risks for companies.
Fritjof Linz: Another important aspect in employing single-use technology is the increased flexibility for product change-overs. Batch sizes are getting smaller. This means that the number of batch change-overs is increasing. Single-use also reduces cleaning outlay, and the risk of cross-contamination is far lower. In terms of simplicity and efficiency, single-use solutions are often definitely the better approach — both from a cost point of view and from an environmental perspective.
PROCESS What role do continuous processes currently play for the biopharmaceutical industry?
Linz: Continuous processes are an important approach for reducing production costs and manufacturing high-quality medical drug products. The challenge is to incorporate the individual process steps in a continuous process. In the upstream area, we already have an established continuous process in the form of perfusion. In downstream processing, initial efforts are being implemented to run process steps in parallel or continuously, for example during chromatography. We are also working on a pilot-scale continuous solution for crossflow filtration.
PROCESS: How will the recent acquisition of parts of the Danaher portfolio help you with this?
Linz: To date our chromatography portfolio has had a strong focus on membrane chromatography. This is now set to change with our purchase of the portfolio we have acquired from Danaher, which will add Bio SMB systems and various resins, among other things. We have widened our offering in a way that will enable us to offer optimum solutions to cover every requirement in downstream processing. We have also brought in reinforcements in the areas of single-use tangential flow filtration systems and flow kits, which means that we can now serve current therapy trends with a range of solutions. Overall, we aim to offer our customers a total, integrated solution in which different systems can communicate with one another.
PROCESS: You mentioned current therapy trends. What solutions do you have available to support the new advanced therapies, for instance?
Linz: We have been following developments in this field very carefully, because there are major opportunities for Sartorius here. In exactly the same way as we experienced previously with monoclonal antibodies, the challenge here is once again to lower production costs and therefore also treatment costs. You can see from our acquisition of a majority interest in the Israeli company Biological Industries that the market segment of advanced therapies is especially important to us. This step marks a significant expansion of our offering in the area of cell culture media.
PROCESS: Which challenges does the biopharmaceutical industry currently face?
Berendsen: Cost-of-goods is an issue that is constantly on everyone's minds. Getting the currently high costs per patient and treatment under control is a challenge for everyone involved. Manufacturers and suppliers alike are both challenged to establish more efficient development and production processes. Single-use technologies, process intensification, and methods of data analytics will play a decisive role in this context. This is why we are using innovative technologies to develop new solutions that will offer increased cost effectiveness throughout the entire process chain — from laboratory research all the way to production.
Thank you for taking the time to talk to us.