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

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.

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.

 

February 2017

Press Release CellGenix – February

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.”

press release

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