About Silke Bolte

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So far Silke Bolte has created 9 blog entries.

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!

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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.


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)

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

January 2018

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.

• 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

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