SOCOREX ISBA SA

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Further Collaborations Sartorius CellGenix GmbH

Am Flughafen 16 79108 Freiburg Germany Prof. Dr. Felicia Rosenthal +49-761-888-89-0 +49-761-888-89-800 info@cellgenix.com cellgenix.com

I Q

80 1994

GMP Clean Room facilities A/B/C/D S1/S2

Ex vivo raw materials for Cell & Gene Therapy Regenerative Medicine

Distribution in Europe for Saint Gobain FEP cell culture and cryopreservation bags

l T cells l MSCs l iPSCs, ESCs l NK cells

High-quality GMP reagents for cell and gene therapy manufacturing

Sartorius CellGenix is a leading global supplier of highquality raw materials for the expanding market of cell and gene therapy as well as regenerative medicine. We develop, manufacture, and market human cytokines, growth factors, and other recombinant cell culture components in preclinical and GMP quality, as well as proprietary serum-free media for further manufacturing of Advanced Therapy Medicinal Products (ATMPs). Our products are used by academia and industry partners in clinical trials and commercial manufacturing throughout the world. As a former ATMP developer and manufacturer we have acquired in-depth cell culture knowledge and superior regulatory expertise. With this unique background we understand the high requirements our customers face during product development and the regulatory approval process.

Sartorius CellGenix is headquartered in Freiburg, Germany and operates a subsidiary near Boston in Portsmouth, NH, USA. In Juli 2021 the life science group Sartorius acquired a majority stake in CellGenix.

Our mission & vision

Our mission is to enable and accelerate safe and efficient transition of cell, gene, and tissue-engineered products from preclinical to post-approval clinical applications for the benefit of patients worldwide. We foster this by providing premium ancillary products, reagents, tools, and expert regulatory support to our academic and industry partners worldwide. We aim to be a key provider in the fight against disease, the preferred supplier of raw materials and tools, and a trusted partner for large-scale manufacturing in cell and gene therapy as well as regenerative medicine.

Our history

Sartorius CellGenix has more than two decades of in-house expertise in GMP manufacturing and the development of products (DC, HSC, cord blood cells,

and chondrocytes) in the field of cell and gene therapy and regenerative medicine. The company was founded in 1994 as a spin-off of Freiburg University Medical Center and was the first European company to obtain a GMP manufacturing authorisation for cell processing in 1995.

Sartorius CellGenix’s current Quality Management (QM) system was established for the manufacture of recombinant protein investigational products (patient-specific idiotype vaccines and recombinant tumour vaccines) in compliance with GMP under manufacturing authorisation from German regulatory authorities. The QM system has been adapted for the manufacture of recombinant raw materials and has been ISO certified since 2012 (currently DIN EN ISO 9001:2015).

With many years of experience in the field of cell and gene therapy, Sartorius CellGenix has always taken active interest in supporting the advancement of the regulatory framework in this evolving environment. We filed the first FDA DMF for a cytokine as ancillary reagent in 2002 and co-authored chapter <92> with the USP in 2010.

Regulatory excellence

Sartorius CellGenix GMP products are based on three major quality standards: › Safety

Safe and qualified raw materials in compliance with our ADCF and serum-free policy. › GMP Compliance

Manufacturing and quality control following all applicable GMP guidelines to provide documented evidence of purity, potency, consistency, and stability. › Regulatory Compliance & Support

GMP products are manufactured, tested, released, and distributed under an ISO 9001:2015 certified

Quality Management System and allow for safe use in accordance with USP Chapter <1043>, Ph. Eur.

General Chapter 5.2.12 and ISO TS 20399. GMP cytokines are tested and released according to USP

Chapter <92> as applicable.