Cell Banking
Comprehensive Cell Banking Solutions
Cell banks are the cornerstone of biopharmaceutical development, playing a pivotal role in ensuring the stability, reproducibility, and regulatory compliance of your valuable cell lines. As a leading CDMO, we understand that the success of your biologics hinges on the reliability of your cell lines.
We offer cell banking services for producer cell lines (protein, plasmid DNA) as well as cell lines used in QC assays. Our GMP facility has segregated BSL-2 suites for cell banking of human, mammalian, insect, yeast and bacterial cell lines. We provide a complete portfolio of cell banking solutions: in a GMP setting with the production Master Cell Banks (MCB), Working Cell Banks (WCB), cell lines used in cell based assays and for your research needs, by delivering Research Cell Banks with QC testing analogous to the GMP standard.
GMP manufacturing
We can offer the manufacturing of GMP Master and Working cell banks for producer cell lines of mammalian, insect or microbial origin. Those cell lines can be used for expression of protein products or for the amplification of plasmid DNA, both for human or veterinary end application. We can also support the production of non-production cell lines for QC purposes like cell-based assays.
Before transferring a project to GMP, we test the expansion of the cells on small scale in a development setting to confirm the cell growth kinetics and quality of the cell line.
Our GMP facility supports storage at -80°C or in the vapor-phase of liquid nitrogen. Our liquid nitrogen tanks and ultra-low-temperature (ULT) freezers are connected to a 24/7 monitoring system.
Our services comprise:
- Manufacturing in accordance with EMA and FDA requirements
- Segregated, grade A/C suites, ISO 5/7 cleanrooms
- Cultivation of BSL1/BSL2 organisms
- Qualified equipment
- Cell culture using serum-free and animal component free media
- Filling within certified laminar flow biosafety cabinets (Class A)
- QP certification
Deliverables:
- Executed and detailed batch record documents
- Manufacturing report
- Certificate of GMP compliance
- BSE/TSE statement
- Certificate of analysis (CoA)
Quality & stability testing
Quality testing of a cell bank is a critical aspect of ensuring the safety, consistency, and reproducibility of biopharmaceutical products and to avoid variability when cell lines are used for QC purposes. Widely known for its analytical testing, all assays to characterize cell lines are available within the vast Eurofins network.
Typical testing panel E.coli/Typical testing panel CHO
Competitive pricing meets short timelines
Our commitment to excellence is reflected in our flexible approach, allowing us to tailor our cell banking services to your specific needs and accommodate short timelines without compromising quality. Partner with us to experience a seamless collaboration that adapts to your timelines and budgetary considerations, driving your biopharmaceutical innovations to market efficiently and affordably.
