• CEVEC’s CAP®Go technology enables CellGenix to offer rh TGF-ß1 in preclinical and now also in GMP-grade quality, allowing a seamless transition from preclinical to clinical development and commercial manufacturing of cell therapy products
• With the introduction of GMP rh TGF-ß1, CellGenix further expands one of the broadest portfolios of GMP cytokines and growth factors for the cell and gene therapy industry
• CEVEC’s CAP®Go technology allows access to GMP-grade cytokines such as TGF-ß1 requiring human post-translational modifications which are not possible by using bacterial expression systems
• Successful launch further proves the robustness and efficiency of CEVEC’s CAP®Go technology for the production of complex glycoproteins

25th Anniversary as a leading manufacturer of high quality raw materials for clinical cell culture needs

As we celebrate our twenty-fifth year in business, all of us at CellGenix would like to express our sincerest appreciation to our valued customers, partners and collaborators. We thank you for your loyal support through the years.

CellGenix was founded as a spin-off of the Freiburg University Medical Center and became the first European company to obtain a GMP manufacturing authorization for processing cells for therapeutic applications. Over the years, CellGenix has pivoted its business from a cell therapy product company to a developer and manufacturer of high quality raw materials for further manufacturing of cell and gene therapies. Today CellGenix’ products are used by leading experts and are proven in clinical trials with a broad range of cell types and indications as well as commercial manufacturing throughout the world.

“Over the last two and a half decades we have seen a lot of great achievements in the cell and gene therapy space. We are excited that we have been able to make a small contribution to the growth and progress in this field that is advancing medicine and helping patients worldwide.” says Prof. Dr. Felicia Rosenthal, CEO and one of the co-founders of CellGenix.

Looking ahead, Dr. Rosenthal adds “as the field continues to advance quickly, we are significantly investing in capacity expansion, process development and leading-edge manufacturing technologies. This helps us to continue meeting the increasing customer demands for GMP-grade raw materials as more and more promising cell and gene therapies approach market authorization and commercialization.”

With the participation of CellGenix a new International Technical Standard was released by the International Organization of Standardization (ISO) providing guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consitency in the aspects of indentity, purity, stability, biosafety, performance, as well as the accompanying documentation.

ISO TS 20399 | Ancillary materials present during the production of cellular therapeutic products

• Part 1: General requirements
• Part 2: Best practice guidance for ancillary material suppliers
• Part 3: Best practice guidance for ancillary material users

We very much appreciate this new guideline as it will help to clearify and thus simplify the requirements for ancillary materials.

CEVEC and CellGenix cooperation leads to expansion of CellGenix cytokine portfolio with CAP®GO Technology-derived TGF-β1 for ex vivo cell culture

• This portfolio expansion is the result of an ongoing collaboration and license agreement between CEVEC and CellGenix for the development and GMP production of selected cytokines for ex vivo cell culture therapy applications using CEVEC’s proprietary CAP®GO technology
• CEVEC’s CAP®GO technology enables CellGenix access to new cytokines and proteins requiring human post-translational modifications not provided by bacterial expression systems
• CellGenix® recombinant human transforming growth factor-beta 1 (rh TGF-β1) is used for the expansion of pluripotent stem cells (PSC) and mesenchymal stem cells (MSC) as well as for the differentiation of T cells into regulatory T cells (Treg cells) and the expansion of Treg cells
• CAP®GO-derived GMP TGF-β1 is planned to become available in the second half of 2018

Cologne and Freiburg, Germany, January 31, 2018

CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, is pleased to note that cooperation partner CellGenix, a leading global supplier of GMP raw materials for cell and gene therapy and regenerative medicine, today announced the expansion of its portfolio with the introduction of CAP®GO technology-derived preclinical grade TGF-β1 for ex vivo cell culture applications. After CellGenix® rh HGF, this is the second product originating from this cooperation.

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CellGenix appoints leading experts to scientific advisory board

Freiburg, Germany, May 15, 2017 – CellGenix, a global leader in providing GMP-grade raw materials for cell and gene therapy and tissue-engineered products, today announced the appointment of highly experienced and internationally respected experts in the field of cell and gene therapy to its Scientific Advisory Board (SAB). The SAB will serve as a strategic resource to CellGenix as it continues to develop high quality raw materials used worldwide in cell and gene therapy and regenerative medicine.

“We are delighted to have attracted these renowned experts to the SAB,” says Prof. Dr. Felicia Rosenthal, CEO of CellGenix. “They join at an exciting time for CellGenix as the field is advancing rapidly and we are increasing our R&D investment. We are convinced that the background and experience of our SAB members will bring new ideas for our product development pipeline. Their input is especially welcome as we are working on various promising products for the future.”

The members of CellGenix’ Scientific Advisory Board are:

• Cliona Rooney, Ph.D., is a Professor in the Center for Cell and Gene Therapy at Baylor College of Medicine. Prof. Rooney brings over 20 years of expertise in the field of T cell immunotherapy for virus-associated diseases and cancer. She was instrumental in the development of T-cell therapies virus-specific T-cells in the stem cell transplant setting and has further developed and refined antigen-specific T-cells for the treatment of cancer. Her current interests are in gene modifications and other strategies to render T-cells effective within an immunosuppressive microenvironment.
• Mitchell H. Finer, Ph.D., brings three decades of experience in the areas of regenerative medicine, cancer immunotherapy and cell and gene therapy, where he helped to advance products from conception through phase III clinical programs.  Dr. Finer founded Oncorus and currently serves as CEO and CSO. In 2015 he joined MPM Capital as Managing Director and is a member of the board of directors of MPM portfolio company Semma Therapeutics. Prior to MPM, Dr. Finer served as CSO of bluebird bio, where he was responsible for strategic elaboration of bluebird’s gene-modified adult hematopoietic stem cell therapy business and led the strategic development and partnering of CAR-T and genome engineering programs.
• Anthony Davies, Ph.D., is the founder and executive chairman of Dark Horse Consulting, a consultancy agency focused on CMC and product development issues in monoclonal antibody and cell and gene therapies. Dr. Davies brings along more than two decades of experience in the cell and gene therapy field. Over this period he has held positions of increasing responsibility at companies including Onyx Pharmaceuticals, Geron Corporation and Capricor.

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Preclinical recombinant human IFN-γ

We proudly announce the launch of E. coli derived recombinant human Interferon-gamma. This new preclinical product further expands our cytokines & growth factors portfolio for the cell and gene thereapy space. It is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in preclinical cell and gene therapy applications.

Features
• E. coli derived human sequence
• High purity
• Termostability up to 50°C as lyophilized product
• Batch specific Certificate of Analysis
• ADCF Level 2 (no ADC in product and production process)

Areas of Application
• Maturation of monocyte-derived dendritic cells (DC)
• Generation of cytokine induced killer cells (CIK)
• Stimulation of monocytes, macrophages and microglia

Intended Use
For preclinical ex vivo use. Not intended for therapeutic use.

Raw materials for cell & gene therapy: exploring regulatory and supply issues

Bernd Leistler, our Vice President Development & Production, was interviewed by the Cell & Gene Therapy Insights about our vision on the regulatory and supply issues for raw materials.

The cell and gene therapy sector has seen a rapid expansion and maturation as more companies are approaching late-stage clinical development and market authorization. We see this reflected in an increased demand for GMP-grade raw materials and discussions about their quality requirements and regulatory guidance. Please click here to download the interview and read about our vision on the regulatory and supply issues for raw materials.

The interview was published in the Cell & Gene Therapy Insights spotlight “Raw materials for cell & gene therapy: getting it right from the start”. You can access the complete spotlight here.

CellGenix headquarters expands to meet the increasing demands for GMP cell culture reagents

Freiburg, Germany, February 21, 2017 – CellGenix, a global leader in providing GMP-grade raw materials for cell and gene therapy and tissue-engineered products, started facility expansions as more customers approach late-stage clinical development and commercialization.

Through early 2018, research and development laboratory as well as production and warehouse space will be added to its German headquarters in Freiburg. Consequently, new positions in research and development as well as quality control and production will be filled. The upgrade also introduces state-of-the-art, large scale, filling capacities for recombinant protein products in the existing GMP facilities.

The expansion is the result of robust, sustainable and profitable growth which the company has experienced over the previous years. These advancements are reflective of the rapidly expanding cell and gene therapy space as promising therapies approach market authorization and commercialization. The experienced industry growth and strong forecasts in cell and gene therapy lead to an increased demand in GMP-grade raw materials for production.

“The investment we are making is a very positive sign for the gene and cell therapy space and the future of CellGenix. It will allow us to fulfill the increasing demand for GMP-grade cytokines and serum-free media. It also shows the importance of high quality GMP reagents for safe, reliable and successful cell and gene therapy manufacturing.” says Prof. Dr. Felicia Rosenthal, CEO of CellGenix.

Frank Hecht, Vice President Marketing & Sales at CellGenix, adds: “With this expansion we strengthen our position as a leading partner for all companies active in the manufacturing of cell and gene therapies and we are ready to grow with them into their commercial phase.”

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