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Life Sciences Company Accelerates Biopharmaceutical R&D with a Dedicated CAE Department

Sartorius leans on its Computer-Aided Engineering department to optimize devices that enable the creation of biopharmaceuticals.

By Joseph Carew
September 2025

Biopharmaceuticals can be effective treatments for illnesses such as cancer, multiple sclerosis, and rheumatism. These novel drug products are highly complex, and their production requires bioreactors, biotechnological processes, and a significant investment in time and resources. The Computer-Aided Engineering (CAE) department at Sartorius, an international pharmaceutical and laboratory equipment supplier, found that using the COMSOL Multiphysics^® software helped them overcome common production challenges by speeding up development time, reducing prototypes, supporting innovation, and optimizing testing.

Making the One in Ten Thousand: Manufacturing a Successful Biopharmaceutical

A biopharmaceutical is any pharmaceutical drug product that has been manufactured in, extracted from, or synthesized from biological sources. Unlike chemical-based drugs, biopharmaceuticals can be customized to target specific cells and include vaccines, somatic cells, tissues, and whole blood among other examples. A recent, notable biopharmaceutical success story is the COVID-19 vaccine. While biopharmaceuticals can boast strong capabilities, the development process is not without challenges.

"Only one of ten thousand new drug candidates reach the market," explained Dr. Friedrich Maier, a senior scientist of CAE simulation at Sartorius. "One drug is above a 2-billion-euro investment in development costs, not to mention the significant time investment as well." (Figure 1)

Biopharmaceuticals are expensive to develop largely because of their complex molecular structure, the specialized manufacturing processes they require, as well as the regulatory requirements on the industry. Physical experiments, in particular, are expensive investments. Modeling and simulation eases this burden and reduces the reliance on those experiments, but it can be a challenge to get the models right. That is because the biological processes that need to be replicated are complex, have high fluctuations, and are not easy to replicate. Sartorius supports their biopharma and life science customers by meticulously integrating the biological processes into their devices, aiming to minimize error propagation and maximize product yield.

Onboarding a CAE Department and Optimizing Collaboration and Development

In 2019, Sartorius introduced an in-house CAE department to help resolve production challenges, and Maier knew exactly where to start: "Our first step was to define the tools we wanted to use," he shared.

Maier and his team were looking to improve the sharing of insights and results between the engineers developing the devices and the scientists looking at the process. The team decided to use the COMSOL Multiphysics^® software, which has since become an important tool in the CAE toolkit and a key ingredient for successful communication and problem solving.

The CAE department trained engineering colleagues on how to use simulation software to create an internal simulation community that can provide quality checks for the company's projects. "Our problems are defined by the physics, the process, the dimension in space and time, and by the materials or material interactions you need to consider in the modeling approaches," said Maier.

Now, years into the CAE department operating at Sartorius, the team has an established development process that combines a CAE and V-model development approach. "In the idea phase, we look at a cost level, and we break it down to the main item, and then, once we understand the processes inside, we build up to the system level again," said Maier. This approach extends across the whole production chain, including the mature stages when experts are brought in to optimize the design, share ideas on how to improve the products, and ultimately produce a digital prototype.

The CAE department at Sartorius is engaged in a diverse array of projects, spanning various scale levels and encompassing a wide range of biopharmaceutical devices. Each project operates independently, allowing for focused innovation. In one initiative, the team developed a bioreactor. Simultaneously, they pursued research on the 3D modeling of membrane structures at the mesoscale, which was a study undertaken independently of the bioreactor project. However, insights from this mesoscale model enhance the design of filters, which are integral components in bioreactor assemblies and other biopharmaceutical devices (Figure 2).

The majority of their simulations are in that macroscale, but Maier and the CAE team also explore system interactions. "Looking at the whole value chain from the raw material to the drug, there is a multitude of requests on our desks dealing from pipettes, over mixers, the downstream area, and then a lot of filtration chromatography steps, freezing and final filling until we reach the drug dose," Maier said. With such a wide swath of projects, the CAE team needs to be able to model multiple physics areas.

"Biopharma is multiphysical," Maier said. "For our products, we have to focus on structural mechanics that ensure the robustness, but we also have to look at the computational fluid dynamics, and we need to know the performance. It is liquid systems everywhere...and here COMSOL Multiphysics is definitely very helpful."

Moving from Model to Manufactured Device

Sartorius' CAE department has often used COMSOL Multiphysics for specialized CFD applications such as mixers and porous media. Additionally, they have worked on projects that needed to account for freezing, welding, reactive transport, heat transfer processes, and fluid–structure interaction (FSI). Through the use of equation-based modeling, Maier has also incorporated controls and control processes to improve design performance, shorten development timelines, and reduce prototyping.

The CAE department's simulations have provided experts throughout the broader organization with detailed insight into diverse phenomena. When it comes to root cause analysis, the experts can strengthen their knowledge with insights not possible with physical testing, such as when it is impossible to look inside the device. Simulation also helps Sartorius' designers with their testing processes.

"We challenge the tests and the tests challenge us. So, it is a back and forth," Maier explained. The results can show uncertainties in the tests as well as in the simulations. From there, the team can extend the tests with additional simulations or metrics that are difficult to measure and optimize their testing efforts.

Developing a Bioreactor Accessory with a Single Prototype

During the COVID-19 pandemic, the Univessel® SU bioreactor portfolio proved the need for high-quality products to manufacture biopharmaceuticals. The original Univessel® SU bioreactor was a key component in BioNTech's production of their first COVID-19 vaccine, and based on its success, Sartorius decided to update it by adding more functions and sizes to it. One of the functions is an important bioreactor accessory: a heat jacket. The heat jacket development represents the CAE department's typical approach. The team began their investigation with an off-the-shelf heat jacket they found on the market that lacked efficiency and decided to model the design to come up with a better one. Building the model representing the new heat jacket design (Figure 3) involved CFD, heat transfer, and equation-based modeling to account for the sensors, switches, and controllers. Maier said that the results provided the development team with clear recommendations, such as where to put switches and sensors and how to distribute the heating, which helps lead them to smart designs.

"We got a nice transient-controlled simulation out of it, and we were able to derive an optimized design," Maier said. The simulation and the real-life experiments saw temperatures meet in perfect agreement, and the team only needed to create one prototype of their design (Figure 4).

Thanks to the tools available to Sartorius' CAE team, the organization has established an efficient and high-performing department that is overcoming the challenges of biopharmaceutical production, with one goal in mind: "We want to empower scientists and engineers to simplify and accelerate progress in life science and bioprocessing and enable them to develop new, better, and more affordable medicines," explained Maier.

Univessel is a registered trademark of Sartorius Stedim Biotech GmbH