53Biologics is a one-stop-shop solution for your cell banks: developement, characterization and storage
Our team design the best strategy for the Cell Banking Manufacturing according to the needs of the project. Our pDNA services include the development of different types of cell banks depending on your manufacturing services quality grade.
End-to-end Cell Banking Services for your pDNA Project
Master Cell Bank Generation
Working Cell Bank Generation
End of Production Cell Bank Generation
Full Characterization Services
Long-term Storage
GMP Cell Banking Services
Our expertise with E. coli enables the construction of a solid, precisely characterized product whether you are transferring an existing clone or developing one from zero. Once a viable clone has been found, we produce, test and release Master and Working Cell Banks (MCB/WCB) in accordance with ICH requirements for viability, identity and purity, laying the groundwork for production and upcoming regulatory filings.
Non GMP Cell Bank: for research purposes and preclinical studies
GMP Cell Bank: for clinical studies and commercial market
Rely on our E. coli Expertise
Our team has a deep expertise in microbial cell banks, particularly in E. colistrain development. We can engineered a customized strain and the expression plasmid combining promoters, selection markers, origins of replication and following your requirements.
We listen and adapt to ensure generation, manufacturing, and characterization align with your pre-clinical or clinical timelines and commercial requirements.