This document provides an overview of EUFETS GmbH, a company that offers integrated product development services for cell and gene therapy. It has state-of-the-art facilities in Germany for manufacturing cell and gene therapy products. EUFETS has over 20 years of experience in manufacturing stem cell and gene therapy products and has contributed to over 1000 stem cell transplant products and clinical trials of various cell and gene therapies. The company provides services for technology transfer, preclinical development, GMP manufacturing, and quality control of cell and gene therapy products.

1. WELCOME TO EUFETS GMBH
Your Provider of
Integrated Product Development Services for Cell & Gene Therapy
EUFETS GmbH - A Company of BioNTech AG

2. EUFETS is part of BioNTech group

3. EUFETS Mission
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4. OVERVIEW – OUR FACILITIES
STATE OF THE ART FACILITIES
»Located in Idar-Oberstein, Germany (1.5 hrs from Frankfurt int. Airport)
»Facility complex: >4,500 m2 (>48,000 sq ft)
»Segregated manufacturing building housing various clean room suites classified up to grade A/B (class 100)
»Well equipped QC laboratories
»Flexible R&D laboratories
»Significant cryogenic storage capacity
»cGMP & cGLP certified
»Biological safety level S2 (conditionally higher)
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5. OVERVIEW – OUR HISTORY
E U F E T S GMBH
A Company of BioNTech AG
1997 Founded as a spin-off from the Idar-Oberstein based Bone Marrow Transplantation Unit 1999 Granted a first Manufacturing licence from the local authorities for the production of stem cell products 2001 EUFETS becomes a subsidiary of Fresenius Biotech GmbH and starts expansion of its GMP facility 2003 EUFETS achieves accreditation as Good Laboratory Practice (GLP) facility New GMP facility is certified by the local authorities for the production of cell- and gene therapy medicinal products 2003 EUFETS develops and manufactures various cell and gene therapy products for projects sponsored by Fresenius Biotech GmbH EUFETS performs first GLP studies 2006 EUFETS establishes and strengthens its third party business and develops and produces novel products for international clients 2009 EUFETS becomes a subsidiary of BioNTech AG, Mainz
2010 EUFETS expands the technology portfolio by implementation of a manufacturing technology for in vitro transcribed RNA 2013 EUFETS acquires major pharma company as client for technology development and contract manufacturing of gene modified T cells 2014 Eufets supports several Phase II and pivotal clinical trials in cell and gene therapy
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6. MANUFACTURING TRACK RECORD IN CELL & GENE THERAPY
OVERVIEW - OUR TRACK RECORD
Technology
Country
EUFETS Contribution
Stem cell transplantation
Germany
Manufacturing and QC of >1000 products (leukapheresis, bone marrow, cord blood, CD34+ stem cells, donor lymphocytes)
Stem cell gene therapy
Germany, Switzerland, EU
Manufacturing and QC of retroviral and lentiviral vector modified stem cells for:
• CGD
• WAS
T cell gene therapy
Germany, EU
Manufacturing and QC of retroviral and lentiviral vector modified T cells for:
• HSV-TK suicide gene therapy
• anti HIV gene Therapy
• Cancer gene therapy with CARs
Other cell therapy
EU
Technology development and Phase II clinical support for 2 DC manufacturing projects
RNA production
Germany
• Manufacturing of > 30 batches of RNA (drug product)
• Manufacturing of > 20 batches of RNA (starting material)
Retroviral vector production
EU, US, Australia
• Manufacturing of > 20 different retroviral vectors for clinical application (3 SIN vectors)
• Batch sizes of 5 to 80 liters
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7. EUFETS GMBH
Services for
Preclinical Product Development
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8. TECHNOLOGY TRANSFER AND PROCESS DEVELOPMENT
DEVELOPMENT SERVICES
»Single point of contact & project management
»>600 m2 lab space of BSL up to S2/S3**
»Process development until GMP readiness
»in house retroviral vector design and optimization
»parallel small scale development work
»strong development analytics
»process optimization and scale up
»Generation of reference and animal trial material
»Well equipped for a diversity of projects:
»10 cell culture work places (LAF, incubator, etc.)
»roller bottle incubators, 3 Wave bioreactors, Quantum
»4 flow cytometers, 1 cell sorter, Bioprofiler etc.
Ȁkta Explorer 100 chromatography skid
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9. PRECLINICAL SERVICES FOR CANDIDATE PRODUCTS
»Specialized in cell based in-vitro bioanalytics
»Wide range of in-vitro models in house
»Experienced in safety and potency testing of diverse products
»Customized services (assay development & validation)
»Analytical services available under both non-GLP and GLP
DEVELOPMENT SERVICES
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10. EUFETS GMBH
GMP Services for
Clinical Product Development
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11. MANUFACTURING - STATE OF THE ART FACILITIES
»GMP certified since 1999
»500 m2 (5,300 sq ft) production area on two levels
»Level 1 optimized for aseptic handling of cell and gene therapy products
»6 suites classified grade C (class 10,000) or grade A/B (class 100)
»Biological safety level of S2/S3**
»Level 2 with 4 additional suites
»Segregated lab building
»Significant product storage capacity
GMP SERVICES
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12. MANUFACTURING OF CELL THERAPY PRODUCTS
»Isolation of primary human cells & subpopulations
»e.g. CD34+, CD3+ cells
»Culture, expansion, manipulation & harvest of cells
»primary human cells, human stem cells and human cell lines
»Differentiation of primary human cells
»Testing and release of the cell based medicinal product
»Cell line development
»Cell banking & cryopreservation
»Option for high intensity γ irradiation of cellular products
GMP SERVICES
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13. MANUFACTURING OF GENE THERAPY PRODUCTS
»Construction of retroviral vectors in house
»Establishment of retroviral producer cell lines
»Cell banking and cryogenic storage (MCB & WCB)
»Bulk production of clinical grade retroviral vector
»batch size up to 350 liters
»concentration of bulk retroviral vector established
»Genetic modification of primary human cells
»eg.T-cells, stem cells
»Genetic modification of mammalian cell lines
»Manufacturing of ivt RNA in gramm scale
GMP SERVICES
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14. THOROUGH QUALITY CONTROL AND PRODUCT CHARACTERIZATION
»Separate quality control department ensuring compliant testing
»Expertise in qualification and validation of assays
»Comprehensive set of analytical methodology including
»Immunocytochemistry ( eg. FACS, ELISA, cytokine release)
»Cell Biology ( eg. tests for clonogenicity, functionality)
»Retrovirology (eg. tests for RCR, infectious particles)
»Microbiology (eg. tests for sterility, mycoplasm, endotoxin)
»BioAnalytics (eg. capillary electrophoresis, qPCR)
»Network of qualified contract laboratories
»Product release by own QP for cell & gene therapy products
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GMP SERVICES