May 2024

Urgently Seeking Simplicity

Cell and Gene Therapy opens up new perspectives and gives patients new hope, when there is no other therapy option anymore. But developing and manufacturing is challenging: It is complex, expensive and time-consuming. It is time to simplify processes, safe and efficient with tailor-made solutions.

Discover how we are reshaping the Cell and Gene Therapy landscape

January 2024

Drug Master File for CellGenix® GMP TCM

We are pleased to announce the submission of a Drug Master File (Type II) to the US FDA (CBER) for CellGenix® GMP TCM.

As for our other GMP products this Master File can be cross-referenced through Letters of Authorization (LOAs). The LOAs are available on request via this link:

DMF Letter of Authorization Request Form

December 2023

Discontinuation of Saint-Gobain Product Line

As of December 1, 2023 Sartorius CellGenix discontinues distribution and supporting the Saint-Gobain’s product portfolio in Europe.

For more than two decades, Sartorius CellGenix cooperated as trustful distribution partner for cell culture and cryopreservation bags. From 2000 to 2013, there was a strategic alliance with American Fluoroseal Corporation (Afc), Gaithersburg, USA, which was acquired by Saint-Gobain Performance Plastics in 2013.

As we are now part of Sartorius, we will no longer sell third-party products.

October 2023

Sartorius CellGenix further expands its production facility

Sartorius CellGenix ground stone laying

Sartorius CellGenix is building a new center of excellence in Freiburg

In order to meet the ever growing demand for high quality raw materials in the cell and gene therapy market we are currently building a new center of excellence in Freiburg, Germany. The new building will include production rooms and laboratories with a gross floor area of almost 10,000 square meters. Sustainability is especially important to us. The goal is the Gold certification for sustainable construction which will set benchmarks in this industry. The new site will be operated in a CO2-neutral manner, among other things through the use of geothermal energy for heating, cold well water for cooling, photovoltaic power generation and a green facade.

With this expansion Sartorius invests around 140 million in our Freiburg site. We expect to more than double the number of employees. In 2025 the building will be completed, and the production will start in 2026.

Read the complete press release: Sartorius establishes competence center for manufacturing components for cell and gene therapies in Freiburg



October 2021

Ask the Expert “Raw Material Validation”

Ask the Expert: Raw Material Validation

Patricia Chimot-Marolle our Senior Regulatory Affairs & Quality Support Manager has participated to the RegMedNet “ask the expert” feature on raw material validation.

Read her and three other experts’ views on several Raw Materials topics ranging from important characteristics or challenges associated with qualifying raw materials to future developments in the following link.

Download the complete article here

July 2021

One-Time Optimization of Advanced T Cell Culture Media Using a Machine Learning Pipeline

Our R & D team published a paper “One-time optimization of advanced T cell culture media” in Frontiers in Bioengineering and Biotechnology.

Paul and Sebastian implemented a machine learning framework to overcome common challenges in cell and gene therapy such as high variability of heterogeneous data and strong sample size limitation. The introduction of a machine learning pipeline resulted in a one-time optimized T cell culture medium and is advantageous when working with heterogeneous biological material.

Read the paper in Frontiers in Bioengineering and Biotechnology (free access)

Sartorius Acquires Majority Stake in Cell and Gene Therapy Raw Materials Supplier CellGenix

CellGenix headquarters in Freiburg to be expanded into a center of excellence for the development and production of high quality raw materials for the cell and gene therapy market.

Freiburg, Germany, 2  July, 2021  The life science group Sartorius, through its subgroup Sartorius Stedim Biotech, acquired a majority stake in the raw material manufacturer CellGenix GmbH. CellGenix will continue to be led by Felicia Rosenthal, the company’s CEO and co-founder.

Founded in 1994 at the University Medical Center of Freiburg, CellGenix is a leading raw material supplier for the cell and gene therapy market. The company produces and markets cell culture components, such as growth factors, cytokines, and media in GMP quality for developing and manufacturing cell and gene therapy products. The company is based in Freiburg, Germany, and has a subsidiary near the biotechnology hub in Boston, Massachusetts, USA.

Sartorius has initially acquired 51 percent of CellGenix, which has been privately owned until now, for around 100 million euros in cash. At the beginning of 2023 and 2026, Sartorius plans to acquire the remaining shares of CellGenix.

» Read more

“For us, Sartorius is an ideal partner with a highly complementary product portfolio that will accelerate our development with its global sales team, enabling us to usher in our next phase of growth,” said Felicia Rosenthal.

“CellGenix has an excellent reputation on the market and brings in high technological expertise and considerable regulatory experience in one of the fastest-growing fields of the biopharma sector. Together, we will support our customers even better in fast-tracking their drug candidates efficiently through the various steps in the development of medicines so that innovative therapies can reach patients faster,” added René Fáber, member of the Executive Board for the Bioprocess Solutions Division of Sartorius.

Sartorius plans to expand the Freiburg site substantially and to establish it as a center of excellence within the group in the areas of development and manufacture of quality critical raw materials for the cell and gene therapy market.

About CellGenix

CellGenix is a leading global supplier of high quality raw and ancillary materials for the expanding market of cell and gene therapy and regenerative medicine. CellGenix develops, manufactures and markets human cytokines, growth factors, and other recombinant cell culture components in preclinical and GMP quality as well as proprietary serum-free media for further manufacturing of ATMPs. As a former ATMP developer and manufacturer, in more than two decades CellGenix gained in-depth cell processing knowledge and superior regulatory expertise. With this unique background, CellGenix understands the high requirements their customers are facing during product development and the regulatory approval process. To meet the increasing demand of GMP quality raw materials for ATMP manufacturing CellGenix has recently expanded manufacturing capacity, built additional R&D and QC laboratories, and warehouse space. The upgrade also introduced state-of-the-art, automated, large-scale capacities for recombinant protein products in the existing GMP facilities.

About Sartorius

The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In fiscal 2020, the company earned sales revenue of some 2.34 billion euros. At the end of 2020, nearly 11,000 people were employed at the Group’s approximately 60 manufacturing and sales sites, serving customers around the globe.

For more information contact:

Evelien Nijssen
Team Leader Marketing
+49 (0)761 88889 434

» Read less

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April 2021

New eBook on Raw Materials for CAR-T Production

Take a look at what recent advancements have been made for CAR-T therapies, including different strategies that could help overcome various manufacturing
obstacles. Explore how the use of serum-free media has gained traction, especially when considering commercial-scale manufacturing.

Register here to read the complete eBook on RegMedNet


CellGenix Appoints Daniel Spatz as Vice President Sales, Marketing & Logistics and Member of the Management Team

Daniel Spatz - Vice President Sales, Marketing & Logistics

CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, is pleased to announce the appointment of Daniel Spatz as Vice President Sales, Marketing & Logistics and member of the management team.

Daniel joined CellGenix in 2021 as Head of Marketing & Sales and Logistics. As Vice President Sales, Marketing & Logistics Daniel will now be responsible for the entire global sales and marketing, logistics and customer service organization. He will contribute to further strengthening CellGenix’ global presence as premium raw material supplier.

Read full press release

March 2021

Women to Watch: enabling safe and efficient production of cell and gene therapies with Felicia Rosenthal

Felicia M Rosenthal

As part of the ‘Women to Watch’ series by RegMedNet our CEO Felicia Rosenthal is at their spotlight on International Women’s Day. 

As one of the co-founders and first General Manager Felicia Rosenthal has led CellGenix since 1994. She studied medicine at the University of Mainz and the University College of London, completed a post-doctoral fellowship at Memorial Sloan Kettering Cancer Center, New York, and received her habilitation for work with retroviral gene transfer in cancer immunotherapy. Felicia obtained her medical specialisation in laboratory medicine.

Felicia also holds an executive MBA degree from the WHU Koblenz and J.L. Kellogg Graduate School of Management at the Northwestern University, Chicago.

Read the interview

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