March 2020

CellGenix launches CellGenix®T Cell Medium GMP-Prototype

CellGenix proudly announces the launch of its T cell medium CellGenix® TCM GMP-Prototype for serum-free expansion and differentiation of T cells. This new T cell medium promotes an early onset of T cell expansion, making it optimal for short protocols and a faster cell therapy manufacturing process.

Features

  • Serum-free and xeno-free medium
  • Promotes an early onset of T cell expansion and sustained viability
  • Supports expansion of CD4+ and CD8+ T cells
  • Promotes a central memory and early differentiated memory T cell phenotype
  • High proportion of cytokine producing cells including polyfunctional cells

The medium is initially offered as GMP-Prototype (GMP will be available soon). The performance is identical to the future CellGenix® GMP TCM, allowing for a seamless transition to GMP.

Application

  • Serum-free expansion and cultivation of T cells
  • Optimized for and verified with CAR T cells
  • Supports expansion of other cell types such as Treg and iNKT cells

Learn more about CellGenix® T Cell Medium GMP-Prototype

December 2019

CEVEC and CellGenix announce the launch of GMP-grade TGF-ß1 for cell and gene therapy applications

  • 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

» Read more

Cologne, Germany, December 19, 2019

CEVEC Pharmaceuticals GmbH (CEVEC), the expert in tailor-made recombinant glycoproteins and gene therapy vectors,  today announced that the Company’s cooperation partner CellGenix GmbH, a leading global supplier of GMP raw materials for cell and gene therapy and regenerative medicine, has launched CellGenix® GMP rh TGF-ß1 for cell and gene therapy applications based on CEVEC’s proprietary CAP®Go technology.

CellGenix® GMP rh TGF-ß1 is the third product resulting from an ongoing cooperation between CEVEC and CellGenix, which was established for the development and GMP production of selected cytokines using CEVEC’s proprietary expression technology CAP®Go. Other products include CellGenix® rh HGF and CellGenix® preclinical rh TGF-ß1. With the availability of TGF-ß1 in both, preclinical and GMP grade, CellGenix’ portfolio of growth factors now covers the entire value chain allowing a seamless transition from preclinical to clinical development and commercial manufacturing of cell therapy products.

“We are very happy to see our successful cooperation with CellGenix resulting in the next product derived from our CAP®Go expression platform,” said Dr. Nicole Faust, CEO & CSO of CEVEC. “With more and more advanced therapy medicinal products (ATMPs) in late stage clinical development, we are experiencing an increasing demand for GMP-grade raw materials. We are convinced that our CAP®Go expression platform based on thoroughly documented suspension CAP cell lines is the technology of choice for manufacturing these important reagents.”

We are very pleased with the successful and supportive cooperation with CEVEC. CellGenix® GMP rh TGF-ß1 is the first GMP protein produced by CellGenix using CEVEC’s CAP®Go expression system,” commented Felicia Rosenthal, Chief Executive Officer of CellGenix. “CEVEC’s CAP®Go technology offers us an extensively characterized and animal-derived component-free expression platform that is safe and meets global regulatory standards. The collaboration with CEVEC allows us to further expand and strengthen CellGenix cytokines and growth factors product portfolio and thereby our position as raw material supplier for the cell and gene therapy space.”

TGF-ß1 – A highly potent advanced therapies medical product in cell-based treatments

Transforming growth factor-ß1 (TGF-ß1) is a cytokine that promotes the growth of induced pluripotent stem cells, embryonic stem cells as well as mesenchymal stem cells used in cell therapy applications. In addition, TGF-ß1 plays an important role in the differentiation of T cells into regulatory T cells (Tregs) and the expansion of these cells. Tregs are a specialized subpopulation of T cells that act to suppress immune responses, thereby maintaining homeostasis and self-tolerance. It has been shown that Tregs are able to inhibit T cell proliferation and cytokine production and therewith could play a critical role in the treatment of inflammatory diseases including autoimmune diseases.

CEVEC’s CAP®Go expression platform allows for the efficient recombinant GMP manufacturing of glycoproteins with authentic human post-translational modifications

The proper glycosylation of proteins such as TGF-ß1 is crucial for the functionality and efficacy of these molecules and can significantly improve physicochemical and pharmacological properties. Glycosylation capabilities are therefore a decisive factor when it comes to choosing the optimal cell lines for the production of these highly complex and difficult to express proteins. CEVEC’s CAP®Go expression platform comprises a comprehensive portfolio of glyco-optimized human suspension cell lines that differ in their glycosylation capabilities and allow for the scalable recombinant manufacturing of a variety of ATMPs used for cell-based treatments.

The development history of CAP®Go cell lines is fully known and thoroughly documented to provide full traceability. The CAP cells are grown in serum-free and animal component-free (ACF) medium which makes them a suitable cell substrate for GMP cell and gene therapy raw materials. CEVEC’s GMP-manufactured CAP® Master Cell Bank has been tested according to ICH Guidelines and WHO Recommendations for cell substrates. In addition, a Biologics Master File for CAP Technology (BB-MF) has been submitted to U.S. FDA and is referenceable for CAP® Technology Licensees, simplifying regulatory approval process for a CAP®-derived product.

About CellGenix:
CellGenix is a leading manufacturer and developer of premium-grade reagents for clinical cell culture needs. The company has more than two decades of in-house expertise in GMP manufacturing and development of products in the field of cell and gene therapy and regenerative medicine. The superior quality GMP raw materials are used by leading experts and are proven in clinical trials and commercial manufacturing throughout the world. CellGenix is headquartered in Freiburg, Germany and operates a subsidiary in Portsmouth, New Hampshire, USA, serving the North American market.

For more information, please visit www.cellgenix.com.
Follow CellGenix on LinkedIn.

About CEVEC:

CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system.

CAP®Go enables the production of high-end biologics. Complex, glycosylated proteins represent a significant portion of the human proteome and are notoriously difficult to express in conventional cell lines such as CHO. The CAP®Go expression platform comprises a portfolio of glyco-optimized human suspension cell lines for the highly efficient production of a broad range of difficult to express recombinant proteins with authentic human or designed post-translational modifications, including plasma proteins, blood coagulation factors and complex cytokines and growth factors.

CAP®GT is a fully scalable manufacturing platform for viral vector production. CEVEC has successfully developed CAP®GT suspension cell-derived viral packaging cell lines, including a stable, helper virus-free AAV production platform, which enable better scale-up and competitive production costs when compared to adherent cell culture systems. CAP®GT suspension cell lines grow to high cell densities and show excellent productivity for a broad range of viruses. Gene therapy vectors such as lentiviral, adenoviral, and adeno-associated viral (AAV) vectors can be produced at industrial scale.

For more information, please visit www.cevec.com
Follow CEVEC on LinkedIn and on Twitter

Contact:

CellGenix GmbH
Prof. Dr. Felicia M. Rosenthal
Chief Executive Officer
P.: +49 761 88889100
E.: publicrelations@cellgenix.com

CEVEC Pharmaceuticals GmbH
Dr. Nicole Faust
CEO & CSO
T.:+49 221 46020800
E.: info@cevec.com

MC Services AG
Dr. Solveigh Mähler
Public Relations
T.: +49 211 52925219
E.: solveigh.maehler@mc-services.eu

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October 2019

CellGenix Appoints Dr. Till Puschmann as Vice President R&D & Business Development and Member of the Management Team

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 Dr. Till Puschmann as Vice President of R&D and Business Development and member of the management team.

Till joined CellGenix in 2018 as Business Development & Senior Project Manager. As Vice President R&D and Business Development, Till will now be responsible for the development of CellGenix’ product portfolio and broadening of the pipeline. He also still acts as Senior Project Manager steering and supporting interdepartmental projects.

Read full press release

May 2019

CellGenix celebrates 25th Anniversary

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.”

February 2019

CellGenix proudly announces scholarship holder for the Master program in Manufacturing of ATMPs

CellGenix is proud to announce that Miriam Ramirez Dominguez was awarded the CellGenix stipend for the novel Master program in Manufacturing of Advanced Therapy Medicinal Products.

Miriam will specialize as Qualified Person as this will allow her to work as a Technical Director in a GMP Facility, the next step in her career.

We wish her every succes in taking the master program!

Read more

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January 2019

New ISO Standard released for AMs

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

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

December 2018

Federal-State Economy Medal for Prof. Felicia M. Rosenthal, CEO CellGenix

CellGenix’ CEO Prof. Dr. Felicia M. Rosenthal has been awarded the Baden-Wuerttemberg economy medal for outstanding entrepreneurial achievements and special merits for the Baden-Wuerttemberg economy. The Minister of Economy, Dr. Nicole Hoffmeister-Kraut presented the high distinction to 11 exceptional personalities and 3 companies at a ceremony in the New Castle in Stuttgart on December 4, 2018.

Read full press release

November 2018

CellGenix Appoints Dr. Udo Nirenberg as Vice President Quality Management and Member of the Management Team

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 Dr. Udo Nirenberg as Vice President of Quality Management and member of the management team.

Dr. Udo Nirenberg joined CellGenix in early 2018 as Head of Quality Management where he is responsible for quality control, quality assurance and regulatory affairs. He will now represent these important areas in the management team and contribute to further advancing the high quality of the CellGenix product portfolio.

Read full press release

October 2018

Make your next career step and apply for a CellGenix stipend!

CellGenix is proud to support a novel Master program in Manufacturing of Advanced Therapy Medicinal Products.

The demand for specialists in process development, manufacturing, quality management and regulatory affairs is large and will continue to increase in the next years. To facilitate growth in the cell and gene therapy space CellGenix is proud to support the Master program in Manufacturing of Advanced Therapy Medicinal Products organized by the Andalusian Initiative for Advanced Therapies and the University of Granada with the collaboration of the Línea IAVANTE ‐ Progress and Health Foundation.

The target audience for this pioneering Master’s program are the professionals presently working (or intending to do so) in GMP‐compliant facilities producing cell therapy, gene therapy or tissue engineered products for human use.

Get ready and apply for a CellGenix stipend!

Read more

 

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August 2018

CellGenix ISO 9001:2015 re-certified

CellGenix is now re-certified according to ISO 9001:2015 quality standard

CellGenix has successfully met the requirements defined in DIN EN ISO 9001:2015. By meeting the extensive criteria for this quality standard, CellGenix affirms its commitment to quality and service.

Compared to the previous 9001:2008 version the latest 9001:2015 ISO certification gives more weight to the context of the companies organisation, interested parties and risk assessment.

 

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