October 2020

CellGenix Completes Facility Expansion to Stay Ahead of the Increasing Demand for GMP Raw Materials

Freiburg, Germany, October 8, 2020 – CellGenix GmbH, a pioneer for GMP grade reagents and a leading global supplier of high quality raw and ancillary materials for cell and gene therapies, announces the completion of the second phase of their facility expansion. CellGenix has reconstructed and expanded their production facility for cytokines and implemented a state-of-the art automated filling and freeze-drying line.

By implementing an automated filling and freeze-drying line and increasing bulkware production footprint, finished product capacity for cytokines is substantially increased. This continues to enable CellGenix to meet the fast-growing demand for critical raw and ancillary materials as more customers reach late-stage clinical development and commercialization of their cell and gene therapies. Scaling up from phase I or II clinical trials to large-scale commercial manufacturing, the demand for GMP cytokines often rises by several magnitudes. Consequently, a secure supply chain is imperative. A delay in delivery or change in product quality could lead to delays in production, not only increasing costs but also putting precious patient samples in jeopardy.

The newly designed and expanded facility enables CellGenix to streamline their production processes. The automated filling process also provides increased accuracy and reduced risks, which further increases the safety of their preclinical and GMP cytokines. The automated filling, stoppering and capping system (operates under an Open Restricted Area Barrier System (ORABS) and) is compliant with EU GMP Annex 1 for the manufacture of sterile medicinal products, also taking into account the new version which is currently under revision. 

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In a first expansion phase in 2018 CellGenix added additional space and personnel in its quality control, R&D, logistics and warehouse departments. By finishing both expansion phases, CellGenix has further strengthened their position as a leading supplier for large scale manufacturing in the cell and gene therapy space.

“The expansion of our facility is a result of the robust, sustainable, and profitable growth, generated by long standing and trustful customer relationships we achieved over many years. CellGenix is now well prepared for the future growth of the cell and gene therapy market. It supports our goal to further establish CellGenix as a key provider in the fight against disease, preferred supplier or raw and ancillary materials and trusted partner for large scale manufacturing of cell and gene therapies.” Felicia Rosenthal, Chief Executive Officer at CellGenix.

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. CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, USA.

For more information contact:

CellGenix GmbH
Am Flughafen 16
79108 Freiburg, Germany
Prof. Dr. Felicia M. Rosenthal
CEO
rosenthal@cellgenix.com

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June 2020

Overcoming Raw Material Challenges in Cell and Gene Therapy Manufacturing

At Phacilitate Leaders World 2020 in Miami, CellGenix led a breakfast briefing to discuss the challenges the advanced therapies industry is facing when it comes to raw materials. Chaired by Frank Hecht, the hour-long briefing brought us a stellar panel line-up of:

  • Stefano Baila of Anemocyte
  • Jon Ellis of Invetech
  • Jef Pinxteren from CellAppliedResearch
  • Bernd Leistler from CellGenix

This video is linked to Youtube

Panel Discussion: Current obstacles in allogeneic CAR-T development and possible future evolution

Our Head of R&D Cell Culture Systems, Ulla Schultz, recently joined a panel discussion focusing on the challenges faced by cell therapy manufacturers in the development of allogeneic CAR-T.

What will you learn?

  • How to overcome the challenges in developing an allogeneic therapy
  • The advantages and disadvantages of an allogeneic product
  • How to best manufacture your T-cell products
  • The future of allogeneic CAR-T and similar products

The experts in this roundtable are:

  • Marcos Langtry, head of Allogeneic Cell Therapy, Lonza Pharma & Biotech
  • Paul Maciocia, Research Department of Heamatology and Cancer Institute, UCL
  • Ulla Schultz, Head of R&D Cell Culture Systems, CellGenix

You can watch the panel discussion here.

May 2020

Ori Biotech and CellGenix to collaborate in order to promote innovation within closed-system, cell and gene therapy manufacturing

Press Release, May 13, 2020

With the Cell and Gene Therapy space evolving, the demand for automated and closed-system solutions to simplify and secure manufacturing processes increases. To bring the industry forwards, CellGenix is building partnerships with companies developing next generation automated cell and gene therapy manufacturing platforms like Ori Biotech.

Utilising innovations from both Ori Biotech and CellGenix, users of the Ori Biotech manufacturing platform can eliminate process bottlenecks and open steps in media and growth factor formulation, preparation and transfers in order to enable higher throughput and reduced costs by eliminating manual handling steps. Through this collaboration our two companies will be able to offer our joint customers an innovative closed-system manufacturing platform including the necessary high-quality raw materials.

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Freiburg, Germany and London, UK, May 13, 2020 –  Ori Biotech Ltd, (Ori), an innovator in cell and gene therapy (CGT) manufacturing and CellGenix GmbH, a leading global supplier of high quality raw and ancillary materials for CGT and regenerative medicine, announced today a non-exclusive strategic partnership to achieve closed-system preparation, formulation and addition of CellGenix media and growth factors within CGT manufacturing for users of the Ori platform.

The Ori platform enables therapy developers and contract manufacturers to achieve more automated, more efficient CGT manufacturing in a closed system.  Utilising innovations from both Ori and CellGenix, users of the Ori manufacturing platform can eliminate process bottlenecks and open steps in media and growth factor formulation, preparation and transfers in order to enable higher throughput and reduced costs by eliminating manual handling steps.  Ori selected CellGenix’ raw material portfolio as a partner because of its high quality standards and over 25 years of experience.  CellGenix are experts in GMP manufacturing of raw materials which offer the highest quality and safety.

“Ori Biotech is continuing to build partnerships with best-in-class experts across the cell and gene therapy ecosystem to help enable our vision of integrated, closed system manufacturing,” said Farlan Veraitch, Co-Founder and CSO, Ori Biotech. “Innovation around the integration of high-quality materials from CellGenix into the Ori full-stack platform is another step toward enabling our customers to have a fully-closed manufacturing process from end-to-end, removing bottlenecks in formulation, preparation and process flow.”

“We are always interested in bringing the CGT industry forward by exploring innovative solutions that help simplify the production process as well as reduce the costs of goods”, said Felicia M. Rosenthal, CEO, CellGenix. “In addition to developing and producing our widely used raw materials and proprietary media solutions, we are building partnerships with companies developing next generation automated cell and gene therapy manufacturing platforms like Ori Biotech.” Till Puschmann, VP R&D and Business Development, CellGenix added “Through this collaboration our two companies will be able to offer our joint customers an innovative closed-system manufacturing platform including the necessary high-quality raw materials.”

“Through our ecosystem partnerships, we hope to provide our customers with integrated solutions that take some of the hassles out of their supply chain and manufacturing processes to allow them to focus on what they do best, delivering life-saving treatments to the patients who need them,” added Jason C. Foster, CEO, Ori Biotech.

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 an ATMP developer and manufacturer, CellGenix gained in-depth cell culture knowledge and superior regulatory expertise. With this unique background, CellGenix understands the high requirements their customers face during product development and the regulatory approval process.  To meet the increasing demand for 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. CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, USA. 
https://cellgenix.com/

 About Ori Biotech

Ori Biotech is a London- and Philadelphia-based CGT manufacturing technology company. Ori has developed a proprietary, flexible manufacturing platform that closes, automates and standardises manufacturing allowing therapeutics developers to further develop and bring their products from pre-clinical process development to commercial scale manufacturing.  The mission of the Ori platform is to fully automate CGT manufacturing to increase throughput, improve quality and decrease costs in order to enable patient access to this new generation of lifesaving treatments. Founded by Dr Farlan Veraitch and Prof Chris Mason in 2015, the Company has brought together a seasoned Board and executive management team with over 80 years of pharmaceutical, cell therapy and venture building experience including CEO Jason C. Foster (Indivior) and CBO Jason Jones (Miltenyi Biotec) alongside industry-leading expert advisors like Bruce Levine, Anthony Davies and Annalisa Jenkins.  www.oribiotech.com

 For more information contact:

CellGenix

Am Flughafen 16
79108 Freiburg, Germany
Felicia M. Rosenthal
CEO
rosenthal@cellgenix.com

Ori Biotech

Jason C. Foster
CEO
jasonfoster@oribiotech.com

 

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Highly efficient T cell manufacturing process with reduced handling steps using CellGenix reagents in the G-rex system

In this application note, we show how enhanced T cell expansion along with the generation of an early differentiated phenotype can be achieved using the G-Rex® system with CellGenix® serum-free reagents, such as CellGenix® T cell Medium (CellGenix® TCM) supplemented with CellGenix® IL-7 and IL-15.

Using serum-free reagents in your manufacturing process removes potential risk and variability introduced when using human serum, yielding a product with a low proportion of PD-1+ cells. The G-Rex® system reduces handling steps for more efficient production, eliminating the need to change media and refeed cytokines over an 11-day culture. The system is scalable, closed system versions are available, and it is widely used in clinical settings.

You can download the application note here.

April 2020

Expert Roundtable: overcoming raw material challenges in cell & gene therapy manufacturing

How do you secure your raw material supply in the ongoing COVID-19 pandemic? Our experts give tips in this expert roundtable about overcoming raw material challenges in cell & gene therapy manufacturing.

Other topics that are discussed are sterile connectivity between GMP raw materials and closed automated cell processing systems, raw material variability and stability, customization vs standardization, regulatory guidelines and how to establish a collaborative business model with your raw material supplier.

The experts in this roundtable are:

  • David Digiusto, Chief Technical Officer, Semma Therapeutics
  • Bernd Leistler, Vice President Production, CellGenix
  • Tom Walls, Associate Director of Supply Chain, Bluebird Bio

You can watch the roundtable here or read the transcript.

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

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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.”

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