Munich (Germany)
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Eurofins BioPharma Product Testing Munich GmbH
Eurofins BioPharma Product Testing Munich GmbH is part of the world's largest network of biopharmaceutical GMP testing laboratories offering comprehensive laboratory services for (bio-)pharmaceutical companies.
With more than 35 years of experience and conducting several thousand GMP tests per year, we are specialized in supporting our customers especially in the fields of biologics and cell & gene therapy testing. Our extensive expertise covers all Quality Control (QC) methods - potency assays, protein analytics, and microbiology. We are well-versed in testing according to various pharmacopeias and client-specific methods.
With over 15,000 square meters of laboratory and office space in Planegg near Munich, we offer our customers comprehensive laboratory services using state-of-the-art facilities and technical equipment.
We are certified according to GMP (Good Manufacturing Practice) by the German authorities. In addition, we are listed with the World Health Organization (WHO) and have been successfully audited several times by the US Food and Drug Administration (FDA).
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Eurofins BioPharma Product Testing Munich is certified according to both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) and accredited according to DIN EN ISO 17025 for the testing of medical devices.
The company is listed with the World Health Organization (WHO) and has been successfully audited several times by the US Food and Drug Administration (FDA).
Certificates and Accreditations
GMP Certification
Certificate Human Pharmaceuticals - Robert-Koch-Straße 3a
Certificate Veterinary - Robert-Koch-Straße 3a
ISO 17025
ISO 14001 Certification
Eurofins BPT Environmental policy poster
Manufacturing License
Permission for veterinary medicines
FDA Registration
We test the quality, safety and efficacy of your (bio-)pharmaceutical drug substances (API), intermediate and finished products. Our range of services includes a variety of pharmacopeias and client-specific methods.
Quality Control for Biologics and ATMPs:
- Potency, protein analytics, and microbiology
- Therapeutic antibodies (e.g. ADCs, monoclonal and bispecific antibodies, nanobodies)
- Proteins, enzymes, vaccines, oligonucleotides (e.g. DNA, Aptamers), mRNA and cytokines
- Cell and Gene therapy
Quality Control for Microbiology:
- Sterile and Non-Sterile-Products
- Microbal Identification
- Hygiene Monitoring - Microbiological Environmental Control
- Monitoring of Water Samples
- EU Batch Release Testing
- EU retest and QP release of finished products from third countries
- Stability Storage according to ICH Conditions
- Study Design
- Analytical Testing Services
Eurofins BioPharma Product Testing Munich GmbH
Robert-Koch-Straße 3a
82152 Planegg/München
Germany
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E-Mail: PharmaTesting@BPT.eurofinseu.com
Call us at:
Phone: +49 (0) 89/899 650 0