Eurofins BioPharma Product Testing Netherlands

Exhibitor- Eurofins

Eurofins BioPharma Product Testing Netherlands is part of the Eurofins’ international network of harmonised product testing laboratories. We have over 20 years of experience serving the (bio)pharmaceutical and medical device industry with laboratory, manufacturing, and consultancy services. Our laboratories offer a broad range of methodologies under GMP authorisation, GLP, and ISO 17025, 9001, and 13485 accreditations. Our services are fully comprehensive and include testing of drug substances, final products, intermediates, starting materials for both small and large molecule drug products, and medical devices. We can support our customers with developing test methods from scratch or transfer client methods under regulatory compliant conditions. Aside from testing, we have multiple aseptic manufacturing units for small-scale compounding and fill & finish activities, including labelling and packaging services. Leveraging our international network of Eurofins companies, we can offer our customers the complete testing package for their product while ensuring regulatory compliance.

Eurofins BioPharma Product Testing Netherlands operates four laboratories located in the Netherlands, covering a broad scope of testing services for pharmaceuticals and medical devices.

Eurofins Bactimm B.V. (Nijmegen) is a microbiological contract laboratory with a focus on the pharmaceutical and medical device industry. This laboratory offers microbiological quality control testing for APIs, raw materials, finished products, and medical devices. Additionally, this laboratory is specialised in performing disinfectant studies, cleaning validations, and environmental monitoring services. Eurofins Bactimm B.V. also offers testing and consultancy services for medical devices leveraging the broad Eurofins Medical Device Testing network of companies.                                                       

Accreditations: GMP (Human and Veterinary Medicinal products), ISO 14001:2015, ISO 9001:2015, ISO 13485:2016

Eurofins PROXY laboratories B.V. (Leiden, Bio Science Park) is a chemical testing laboratory focused on performing chemical quality control testing, chemical method development, validation, and transfer studies, and stability & storage. Eurofins PROXY laboratories B.V. is specialised in process residuals and impurity testing using proprietary in-house methods or customised developed methods. Besides facilitating testing, there is also a manufacturing department where small-scale compounding and fill & finish activities can be performed. Labelling and packaging services and QP release for final products are also offered.

Accreditations: GMP (Human and Veterinary Medicinal products), GDP, ISO 14001:2015

Eurofins Microsafe Laboratories (Leiden, Bio Science Park) (part of Eurofins PROXY laboratories B.V.) is a microbiological contract laboratory specialised in microbiological quality control testing, cell banking, cell line characterisation, and method development, and – transfer of microbiological and viral assays in a GMP environment. Eurofins Microsafe Laboratories is a Eurofins Centre of Expertise in Mycoplasma testing with many years of experience in mycoplasma testing and in-house produced, highly sensitive, mycoplasma media for a broad range of mycoplasma. Next to mycoplasma testing, many additional biosafety testing services such as virology testing, endotoxin testing, and testing using state-of-the-art molecular biology techniques are offered.

Accreditations: GMP, ISO 14001:2015

Eurofins Spinnovation Analytical B.V. (Oss, Pivot Park) is a Eurofins Centre of Excellence for NMR spectroscopy. Eurofins Spinnovation Analytical B.V. is a chemical testing laboratory offering solid-state characterisation services, spent media analysis, NMR quality control testing, and root cause investigation services. For spent media analysis, we use our proprietary Spedia-Predict™ method, an innovative solution to evaluate performance variability and develop predictive models for specific bio-manufacturing processes. Additionally, solid-state NMR (ssNMR) characterisation services such as reference qualifications, identification, and polymorphism are offered all under GMP.

Accreditations: GMP, ISO 14001:2015

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