About Silke Bolte

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So far Silke Bolte has created 4 blog entries.

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.

 

Successful 6th “Expert Symposium on Chances & Challenges of cell-based therapeutics” organized by CellGenix

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-Ehrlichl-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 (Viece 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

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.

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