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

 

Organized by:

 

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.

 

6th “Expert Symposium on Chances & Challenges of cell-based therapeutics”

July 12 and 13, 2018 CellGenix has organized and hosted the 6th “Expert Symposium on Chances & Challenges of cell-based therapeutics” at its headquarters in Freiburg, Germany. The symposium has brought together opinion leaders form academia, industry, and regulatory agencies from Europe and the USA to share their perspectives and the most significant advances of their work in cell and gene therapy. This year a focus of presentations was on how T and NK cells can be turned into therapies and how the promise of stem cells can be brought to patients.

A big THANK YOU goes to all our participants – it was truly a remarkable meeting!

From left to right:

Prof. Dr. Roland Mertelsmann (Professor Emeritus, University Medical Center Freiburg)
Dr. Stefanos Theoharis (Senior Vice President, Cell Medica)
Dr. Jessica Hartmann (ATMP Assessor for Div. Med. Biotechnology, Paul-Ehrlich-Institute)
Dr. Robert Hofmeister (Chief Scientific Officer, TCR2 Therapeutics)
Prof. Dr. Ulrike Köhl (Director, University Medical Center Leipzig and Fraunhofer-Institute for Cell Therapy and Immunology IZI)
Dr. Lothar Germeroth (Senior Vice President, Juno Therapeutics)
Prof. Dr. Felicia Rosenthal (Chief Executive Officer, CellGenix)
Dr. Bernd Leistler (Vice President Development & Production, CellGenix)
Dr. Anthony Davies (President, Dark Horse Consulting)
Dr. Elisa Kieback (Chief Executive Officer, T-Knife)
Dr. Gabor Veres (Vice President Translational Research, bluebird bio)
Dr. Lorenz Studer (Director, Center for Stem Cell Biology, Memorial Sloan Kettering Center)
Dr. Udo Nirenberg (Head of Quality Management, CellGenix)
Dr. Margo Roberts (Senior Vice President, Discovery Research, Kite Pharma)
Dr. Felicia Pagliuca (Vice President, Cell Biology R&D, Semma Therapeutics)
Prof. Dr. Cliona Rooney (Professor Pediatric Hematology and Oncology, Baylor College of Medicine)
Dr. Mitchell Finer (Chief Executive Officer, Oncorus & Managing Director, MPM Capital)
Dr. Stewart Abbot (Chief Development Officer Adicet Bio)

June 2018

Press Release CellGenix – June

CellGenix Completed First Step of Facility Expansion to Stay on Top of the Increasing Demands for GMP Cell Culture Reagents

Freiburg, Germany, June 21, 2018 CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion as more customers approach late-stage clinical development and commercialization. In a first step, the company added additional space to its headquarters in Freiburg, Germany. Quality control, research and development laboratories as well as logistics and warehouse space have already been put into operation.

As the next step, a state-of-the-art, automated filling and freeze-drying line will be implemented in the existing GMP facility increasing finished product capacity for recombinant proteins by more than tenfold. This second phase of expansion is expected to be completed in the spring of 2019.

Positive clinical data, a supportive financing climate and clearer regulatory requirements have led to a strong growth in the cell and gene therapy space. This is predicted to persist. The building extension allows CellGenix to continue meeting the increasing demands for GMP-grade raw materials as more and more promising cell and gene therapies approach market authorization and commercialization.

“We are really excited about our new facility and the additional flexibility it provides. It supports our goal to become a key provider in the fight against disease, the preferred supplier of raw materials and tools and trusted partner for large scale manufacturing in the cell, gene therapy and regenerative medicine space. The expansion of our facility is a result of the robust, sustainable and profitable growth we achieved over the last years,”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. It enables us to meet increasing demands for high quality raw materials and, ultimately, help more patients.”

full press release Dr. Stefan Thoma (1st person on the left), Prof. Dr. Felicia M. Rosenthal (person in the middle) and the team of the construction company moser on the opening day of the new building

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.

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