We offer GMP production master and working cell banks, GMP non-production master and working cell banks and R&D cell banks, as well as banking for end of production cells upon request. We perform all GMP production cell banking in our Grade A/B (ISO 5/7) and A/C (ISO 5/8) clean room suites, in accordance with EMA and or FDA requirements, and prepare all other banks in clean cell culture labs where no work with adventitious agents occurs.
We are committed to deliver the highest quality of services to our clients. Together with our sister company Eurofins Lancaster Laboratories in the USA we offer mirror-services on both sides of the Atlantic:
- High-level of experience
- Exact quality oversight
- Client-specific documentation
- QA-approved analysis certificate
Facilities and Instrumentation
- Grade A/B and A/C cell banking suites
- ISO5/7 and ISO 5/8 Clean Rooms
- Qualified Controlled Rate Freezers
- Qualified CO2 Incubators
- Automated Cell Counting (Vi-Cell™)
Cell-line Characterization
Eurofins BioPharma Product Testing Netherlands offers a range of assays to qualify cell banks in the biopharmaceutical production process. This includes cell line authentication and purity tests to ensure that your cell line is pure and free of contaminants.
Is your cell bank free of contaminants?
Eukaryotic and prokaryotic cell banks represent enormous potential value over the lifetime of the product. Therefore, international guidelines require that the cells should be qualified according to stringent standards prior to their release for use.
With years of experience and as a GMP/FDA/WHO-(pre)qualified lab, Eurofins BioPharma Product Testing Netherlands is an excellent partner to make your production process compliant to international guidelines.
What products should be tested?
Eurofins BioPharma Product Testing Netherlands provides testing and qualification solutions for prokaryotic and eukaryotic:
- Cell lines
- Master Cell Banks (MCB)
- Working Cell Banks (WCB)
- Virus seed stock
- Raw materials and final products
- End-of-Production Cells (EOPC) or Post Production Cell Banks (PPCB)
We offer complete characterization of mammalian, insect and microbial cell banks according to ICH guidelines.
Standard ICH-compliant assays for Eukaryotic Cell Banks
- Sterility testing
- Mycoplasma testing
- Identity testing
- Retrovirus testing
- Bovine/Porcine assays
- Specific virus assays
- In vitro testing
- In vivo testing
- Electron microscopy analysis
- Customized testing packages
Standard ICH-compliant assays for Prokaryotic cell Banks
- Monosepsis / Purity test
- Bacteriophage detection
- Infectious titer and viability test
- Identity by sequencing
- Genetic stability test
- Retention of selectable markers
- Retention of recombinant construct
- Copy number determination
- Restriction enzyme map analysis
- DNA sequencing
- Customized testing packages
Cell-line Production and Storage
Eurofins BioPharma Product Testing Netherlands (EBPT-NL) offers expert capabilities in Eukaryotic and Prokaryotic Cell Banking. With more than 20 years of experience in cell culture, we provide the best expertise in development and GMP production of your cell line.
Our facilities support the GMP manufacturing of production Eukaryotic cells in a dedicated state-of the art clean room (Class A / B background). The GMP production Microbial cell banks are manufactured in the isolator (Class A / C background). Consequently, we offer the complete Cell Line Characterization package for your master and working cell banks. We guarantee the best quality cells as platform for the production of your products.
We also offer manufacturing of non-production cell lines for Quality Control purposes in our Cell Culture laboratories. To complete the non-production cell line package, we will test these cells for morphology, viability, absence of Mycoplasma, Identity and Sterility. As a result, you will receive a quality controlled uniform cell bank which will eliminate variability often encountered during cell based assay and thus increase the robustness of your method.
What do we offer?
- Preparation of mammalian, insect and microbial cGMP master and working cell banks
- Preparation of non-production and research banks
Trust the storage of your cell banks in our 24/7 monitored GMP storage units.
Why choose Eurofins BioPharma Product Testing Netherlands?
- Great flexibility. Our focus on small scale projects allows all flexibility you need.
- Single-point-of-contact. With a wide array of services internally available, all communication is centralized.
- Complete service portfolio. Many additional chemical, microbiological and ancillary services performed in GMP certified, WHO prequalified and FDA approved labs.
- Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.
To discuss your Cell Banking demands or to request a proposal, please contact us.
