We have many years of experience in production of GMP-compliant non-production master and working cell banks, as well as R&D cell banks. Our clean cell culture laboratories ensure that all cell banking preparations are conducted in controlled environments free from adventitious agents, and strictly adhering to GMP standards.
Facilities and Instrumentation
- BSL2 Cell Culture Labs
- Qualified Controlled Rate Freezers
- Qualified CO2 Incubators
- Automated Cell Counting (NC 200)
- Liquid nitrogen storage
Cell-line Characterisation
Is your cell bank free of contaminants?
Eurofins BioPharma Product Testing Netherlands offers a comprehensive portfolio of assays for qualifying cell banks in the biopharmaceutical production process. We are specialised in cell bank characterisation of both GMP non-production and production master and working cell banks.
Our services include cell line authentication and purity tests to ensure your cell line is both pure and free from contaminants.
What products should be tested?
Eurofins BioPharma Product Testing Netherlands provides cell line 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 characterisation 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 (AVA)
- In vivo testing
- Electron microscopy analysis
- Customised testing packages
Standard ICH-compliant assays for Prokaryotic cell Banks
- Monosepsis / Purity test
- Bacteriophage detection (E.coli)
- Viability test
- Identity by 16s sequencing (outsourced)
- Karyotyping (outsourced)
- Retention of selectable markers (antibiotic resistance)
- Retention of recombinant construct
- Copy number determination
- Restriction enzyme map analysis (plasmids)
- DNA sequencing
Cell-line Production and Storage
Eurofins BioPharma Product Testing Netherlands offers expert capabilities in eukaryotic cell banking. With more than 20 years of experience in cell culture, we are specialised in development, production, and storage of your non-production cell banks, under GMP standards.
Our clean cell culture laboratories ensure that all cell banking preparations are conducted in controlled environments, all under GMP compliant conditions. Additionally, we offer the complete Cell Line Characterisation package for your master and working cell banks.
We provide production of non-production cell lines for quality control purposes in our cell culture laboratories. Our comprehensive service includes testing for cell morphology, viability, absence of mycoplasma, identity, and sterility. This ensures that you receive a high-quality, uniform cell bank, minimising variability in cell-based assays and enhancing the robustness of your methods.
Our services
- Preparation of cGMP mammalian and insect master and working cell banks
- Preparation of non-production and R&D cell banks
- Cell bank storage
Why choose Eurofins BioPharma Product Testing Netherlands?
- Single point of contact. Benefit from streamlined communication through a single local point of contact while leveraging the advantages of our extensive global network.
- Complete service portfolio. Leveraging our network of GMP product testing laboratories, we can offer a comprehensive testing service portfolio to our customers.
- Standard and custom solutions. If our standard methods do not meet your needs, our skilled technicians can develop customised testing methods tailored to your specific requirements.
To discuss your Cell Banking needs or to request a proposal, please contact us.
