May 2018

Top 5 tips & Interview in “In focus” of RegMedNet

Are you well prepared for large-scale commercial manufacturing?

Interview – Raw materials considerations for GMP manufacturing

In this interview, Bernd Leistler, Vice President Development & Production, CellGenix GmbH, discusses how raw or ancillary materials can affect cell therapy development and manufacturing. Read the interview here.

Infographic – Top 5 tips to prepare you for large-scale commercial manufacturing

Discover how you can ensure your GMP grade raw material supply chain is prepared for commercial manufacturing. Check out the Top 5 Tips infographic here.

 

Read the entire In focus on cell therapy development from RegMedNet

March 2018

Technote – Consistency Studies

New Technote – Batch-to-Batch Consistency of CellGenix® GMP Cytokines

We confirmed that the batch-to-batch consistency of our CellGenix® GMP cytokines is very high

Inconsistent product performance of raw materials causes deviations in the cell therapy manufacturing process. It is unlikely that you will be able to use the same raw materials batch during all stages from early clinical studies to commercial manufacturing. It is therefore crucial to choose GMP raw materials with a high and reliable batch-to-batch consistency. This will allow you to plan your manufacturing process as accurately as possible and save time and cost of goods on incoming controls and revalidations.

To make sure your manufacturing process is not influenced by using different batches of GMP cytokines, we have performed batch-to-batch consistency studies for our key CellGenix® GMP cytokines. These studies demonstrate that our batch-to-batch consistency is very high over the full range of production.

Please download the Technote to have a detailed overview of our batch-to-batch consistency studies.

January 2018

Press Release CellGenix – January

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.

press release

New Preclinical Cytokine

CellGenix® Recombinant Human Transforming Growth Factor-beta 1
(rh TGF-β1)

We proudly announce the launch of CAP® cell line derived Recombinant Human Transforming Growth Factor-beta 1.
This new preclinical product further expands our cytokines & growth factors portfolio for the cell and gene therapy space.

Features
• Preclinical grade – will be further developed to GMP
• Contains neither animal- nor human-derived materials
• High activity, purity and product stability

Areas of Application
Differentiation of T cells into Treg cells as well as the expansion of Treg cells
• Expansion of embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs)

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

Learn more about CellGenix® rh TGF-β1

October 2017

CellGenix Lecture – Prof. Luc Douay

In vitro red blood cell generation: from bench to factory

We are excited to announce the fourth CellGenix Lecture given by Prof. Luc Douay. He will present an overview of the main biological advances of the past decade for large-scale production of red blood cells. With our CellGenix Lectures we want to provide insights in the latest advances in the cell and gene therapy, and the regenerative medicine field.

Abstract
Blood-transfusion centers regularly face the challenge of donor blood shortages, especially for rare blood groups. The possibility of producing universal red blood cells from stem cells industrially has become a possible alternative since the succesful injection of blood generated in vitro into a human being in 2011. Although there remain many biological and regulatory issues concerning the efficacy and safety of this new product, the major challenge today for future clinical applications is switching from the current limited 2-dimensional production techniques to large-scale 3-dimensional bioreactors. In addition to requiring technological breakthroughs, the whole process also has to become at least five-fold more cost-efficient to match the current prices of high quality blood products. Prof. Douay will sum up the main biological advances of the past decade, outlines the key biotechnological challenges for the large-scale cost-effective production of red blood cells, proposes solutions based on strategies used in the bioindustry and presents the state-of-the-art of large-scale blood production.

Speaker
Luc Douay, Prof, MD, PD
Université Pierre et Marie Curie
EryPharm, Président et directeur scientifique
Paris, France

When
Wednesday, October 25, 2017
17:00-18:00 p.m., followed by a drinks reception with pretzels and wine

Where
CellGenix GmbH
Am Flughafen 16
79108 Freiburg

We would be happy to welcome you at our lecture. Please register for free via Lectures@cellgenix.com or T: 0761/88 88 9-0.

September 2017

Article – Cell & Gene Therapy Europe

Raw materials for ATMP manufacturing: regulatory and supply issues

The cell and gene therapy space has seen a great deal of growth and progress over the last couple of years as more companies are approaching late-stage clinical development and market authorization. But what does this mean for the manufacturing process? What challenges remain and how can they be overcome?

Read our vision on how scale-up can be achieved in a reliably safe and consistent way: article

 

Join our roundtable session at the Cell & Gene Therapy Europe to continue this discussion: September 20 at 10:30-11:15

May 2017

Press Release CellGenix – May

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.

press release

April 2017

New Preclinical Cytokine

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.

Interview in Cell & Gene Therapy Insights

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 Lectures – Prof. Dr. Evelyn Ullrich

Recent advances in NK cell translational research and clinical application in malignant diseases

We are excited to announce the third CellGenix Lecture given by Prof. Dr. Evelyn Ullrich. She will present recent results from translational NK cell research an give an overview on NK cell clinical studies. With our CellGenix Lectures we want to provide insights in the latest advances in the cell and gene therapy, and the regenerative medicine field.

Abstract
Natural killer (NK) cells are a promising tool for the use in immunotherapy, since they efficiently recognize and kill tumor cells. For adoptive cell therapy, NK cells from different sources can be stimulated with cytokines and accessory or feeder cells. Clinical studies exploiting the impact of NK cells in the context of hematopoietic stem cell transplantation (HSCT) have provided promising results due to their antitumor capability supporting the graft-versus-leukemia effect (GVL) without causing graft-versus-host disease (GVHD) which is one of the most severe complications in allogeneic HSCT. Furthermore, remarkable advances have been made in the development of CAR NK cell technologies.

Speaker
Prof. Dr. Evelyn Ullrich
Head of Cellular Immunology
Department of Pediatric Stem Cell Transplantation and Immunology,
Johann Wolfgang Goethe-University, Frankfurt/Main

When
Thursday, April 27, 2017
17:00-18:00 p.m., followed by a drinks reception with pretzels and wine

Where
CellGenix GmbH
Am Flughafen 16
79108 Freiburg

We would be happy to welcome you at our lecture. Please register for free via Lectures@cellgenix.com or T: 0761/88 88 9-0.

 

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