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Eurofins BioPharma Product Testing Netherlands

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Eurofins PROXY Laboratories

Archimedesweg 25
2333 CM Leiden
The Netherlands
Tel: +31 (0)71 524 4080

Equipment List

Eurofins PROXY Laboratories, based in the Netherlands, is an independent provider of laboratory testing and manufacturing services to the international life sciences market.

Services range from physical and chemical quality control testing of pharmaceutical raw materials to finished dosage forms, thereby covering release, stability and validation. Its Development, Validation and Stability department can develop test methods from scratch or based on client methods.

In addition to testing, Eurofins PROXY Laboratories has  aseptic manufacturing units in which small-scale compounding and fill & finish activities of clinical trial material are performed. Furthermore, we offer related services, like labelling, packaging, storage and distribution. Inprocess and release testing, as well as QP batch certification are services we provide.

Services:

  • Quality Control testing
  • Analytical method development and validation
  • Stability testing
  • EU-import analysis and release
  • Manufacturing of sterile clinical trial medication

Accreditations/Certifications/Registrations:

  • EP, USP, BP, JP compliant
  • GMP compliant
  • FDA audited
  • WHO


In close cooperation with our Eurofins BioPharma Product Testing sites across Europe,  we are able to offer the full service package, including microbiological and potency assay testing.


 

Eurofins MicroSafe Laboratories

Darwinweg 24
2333 CR Leiden
The Netherlands

Tel: +31 (0)71 408 3700
Equipment List

Eurofins MicroSafe LaboratoriesEurofins MicroSafe Laboratories, based in the Netherlands, is an independent provider of laboratory testing and manufacturing services to the international life sciences market.

Services include testing of biologics and other pharmaceutical products on microbial or viral contamination for release, stability testing and validation. Eurofins MicroSafe Laboratories offers unique services in viral safety testing, bacterial and mammalian cell banking and cell characterization. Apart from performing compendial tests, client-based test methods can be implemented, or novel methods developed and validated. 

Our strong operational teams provide professional expertise at the Master- or PhD-level, combined with years of experience in developing and validating microbiological, virological and molecular biological assays under GMP conditions.

Services:

  • Cell Banking GMP Manufacturing and Characterization (Prokaryotic and Eukaryotic)
  • Mycoplasma Testing
  • Microbiological Testing
  • Virological Testing
  • Compendial Testing
  • Bacteriology including Sterility Testing
  • Molecular Biology
  • Potency Assays
  • Customized Assays

Accreditations/Certifications/Registrations:

  • GMP compliant
  • GLP
  • FDA audited
  • WHO

 

Eurofins Bactimm

Middenkampweg 19
6545 CH Nijmegen
The Netherlands

Tel: +31 (0)24 371 5280


Eurofins Bactimm is a microbiological contract laboratory with a focus on the pharmaceutical and medical device industry. In addition, Eurofins Bactimm provides microbiological testing services to the health care and cosmetics industry.

Eurofins Bactimm was founded in the eighties, at first as a manufacturer of microbiological culture media, especially for clinical purposes.

Through the years, Eurofins Bactimm introduced testing services for medical devices, food and veterinary industries as well as hospitals. In 2000, EU-GMP certification was acquired in Nijmegen and a broad range of microbiological tests were introduced to the market, such as: testing of pharmaceuticals, suitability testing, qualification of irradiation processes, disinfectant testing and container closure testing.

Eurofins Bactimm has many years of experience in medical device testing. In 2010, Eurofins Bactimm moved to newly build cleanroom facilities.

Services:

  • Microbiological quality control testing of API’s, raw materials, finished products and medical devices in compliance with cGMP
  • Analytical method development and validation
  • Disinfectant efficacy studies
  • Microbiological contamination control in cleanrooms

Accreditations/Certifications/Registrations:

  • GMP compliant
  • ISO 9001: 2015
  • ISO 13485: 2016

 

Eurofins Spinnovation Analytical

Kloosterstraat 9 (Pivot Park RK)
5349 AB Oss
The Netherlands

Tel: +31 (0)24 240 3400

Equipment List

Eurofins Spinnovation

Eurofins Spinnovation Analytical is a Contract Research Organization expert in delivering high-end analytical services and QC testing to the Life Science Industry. We are the Centre of Excellence of Eurofins BioPharma Product Testing for NMR and Solid-state Characterization. Our core activity focuses on addressing your needs in process and drug product development, product characterization, biomanufacturing process optimization and troubleshooting, QC Testing, and batch release of your Raw Materials and Drug Products.

We provide you access to our GMP-compliant technology platform which notably includes a wide range of NMR spectroscopy methods, Solid-State Characterization methods (XRPD, ssNMR, DSC, TGA, DVS, etc), and ICP-OES. The company serves both the Small Molecules and the Biologics Pharma market.

Services:

  • NMR characterization and QC testing, GMP compliant
  • Solid-state characterization (Solid-state NMR, XRD, DSC, TGA, DVS)
  • Spent media analysis (Spedia-NMR™)
  • Bioprocess troubleshooting and lot-to-lot variability investigation

Accreditations/Certifications/Registrations:

  • GMP compliant
  • FDA audited