Part of the Solution: How Scientists in Freiburg Give Their Everything to Help Cells Grow for Innovative Therapies
In 2002, Fred Simon’s blood sample became a game-changer for patients worldwide and a start-up in Southern Germany. Little did he know that his DNA would shape the production of cytokines for decades to come.
This article is posted on Sartorius Blog.
It’s the year 2002: Fred Simon works as a student scientist at a small, still young biotech company called CellGenix, a spin-off of the University of Freiburg, in the South of Germany. He had joined the company as a graduate student two years earlier, working on a phase 1 production for a patient-specific cancer therapy for his thesis.
"While waiting for further licenses, we came up with a creative idea. We realized that the high quality standards required for GMP manufacturing couldn’t be met by the "research use only" cytokines that were available at that time," Fred recalls. Up until then, the team had not been producing cytokines themselves. These proteins support the growth and differentiation of various types of cells and are thus essential components for cell and gene therapies. "We thought, what if we used expertise from Molecular Therapeutics to to manufacture high-quality cytokines ourselves?"
We thought, what if we used expertise from Molecular Therapeutics to manufacture high-quality cytokines ourselves?
Frederic Simon, Manager of Process Development Proteins
Now, the development of such cytokines requires DNA, so Frederic and another colleague rolled up their sleeves, stretched out their arms and had some of their own blood drawn – from which the necessary DNA could be taken and cloned. A short time later, the first cytokines were produced based on their DNA.
Twenty years later, CellGenix, now part of Sartorius, is a leading company in the production for pre-clinical and GMP cytokines and growth factors and set to become competence center for the development and production of quality-critical raw materials for the cell and gene therapy market.
From Fit for Clinical Trials to Selling More Than a Physical Product
Cell and gene therapies among the new modalities in biopharmaceutics. These patient-specific therapies are considered a major part of the solution and the next milestone in the fight against currently incurable diseases.
Twenty years ago, there were only few clinical trials for such therapies ongoing – but they still required cytokines. At that time, however, there virtually no one who could produce them to "Good Manufacturing Practices" standards.
"Back then, it really was a market niche - but we recognized that there will be demand in the future for high-quality and safely produced therapies," Dr. Felicia Rosenthal, founder and CEO of CellGenix, explains the decision to not only invest in cytokine production but to add "GMP quality" to the product’s features.
"You can say that we are selling more than a physical product today. Even though there is no official GMP certification given for the manufacturing of raw materials, high quality raw materials are required by the regulatory authorities to ensure safety, efficacy, and batch-to-batch consistency. We have been actively involved in many of the regulatory initiatives and discussions and have more than 25 years of experience in the cell and gene therapy field. This background allows us to offer expert regulatory support to our customers." Over time, further raw materials were added to the company’s product portfolio, such as cell culture media - all in GMP quality.
Next: New Capacities, New Proteins
With demands growing, the Freiburg team is expanding its production capacity with a new facility. For comparison: The former annual output was 2 g of cytokines - the amount of less than a sugar cube. The new facility, for which construction is already underway, will significantly increase capacity.
What’s also on the team’s agenda is the development of new proteins. For example, IL-12 and IL-18, cytokines needed to develop therapies based on natural killer cells, which help identify and attack foreign cells – such as cancer cells - in the body.
Fred Simon is involved in both plans. In his current role as Head of Process Development Proteins, he is engaged in the construction planning for the new site as well as in the development of new products. "We are planning the production set-up in our new facility: How do we scale up the different production processes? What equipment do we need and in what quantities?" he points out.
That’s actually what I like most about my work: Discussing how to set up processes with my team. Fiddling around and testing new devices.
Frederic Simon, Manager of Process Development Proteins
"I’m also kind of a scientific advisor for our product development. I pass on scientific information and give forecasts on how we could realize new products with our production set-up and manufacture a certain protein, like IL-12 and IL-18 for natural killer cell therapies and how much we could potentially harvest," Fred explains his daily work.
"That’s actually what I like most about my work: Discussing how to set up processes with my team. Fiddling around and testing new devices. Discussing how to fold our proteins to get them in the right shape. Every protein is different, lots of fine-tuning is necessary, and there is no standard recipe, so we have to experiment and see how we can do it," Fred says.
Growth Opportunities Through Joined Forces
Furthermore, his work is also affected by the fact that the team is now part of Sartorius, as the subgroup Sartorius Stedim Biotech holds a majority stake in CellGenix.
"We get requests from other teams within the group to develop new products, and we use Sartorius products in our own production. Especially the bioreactors are well suited for us because we are manufacturing in campaigns, meaning we manufacture several products on one production line and by using single-use equipment. We can now set up new campaigns much faster and safer because there is no need for time-consuming cleaning. And we are also using cell-lines from our Sartorius colleagues in Ulm," Fred lists some of the synergies he is currently experiencing in operations.
In addition, there are strategic advantages, as founder & CEO Felicia points out: "CellGenix has been living off its own products for almost 30 years, which is rare in the biotech industry, where many start-ups get acquired by bigger companies in early stages. But if you want to grow, you need a strong partner at some point. Being part of Sartorius now gives us the necessary resources to usher in our next phase of growth. In our ambition to become a center of excellence within the group, we need more people – from R&D, to services, to operations," Felicia says. "So, we can say that we’re growing with Sartorius in every respect."