53Biologics is able to construct, characterize and store cell banks for your pDNA research, preclinical, and clinical applications
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.
Non GMP Cell Bank: for research purposes and preclinical studies
GMP Cell Bank: for clinical studies and commercial market
We listen and adapt to ensure pDNA cell bank generation, manufacturing, and characterization align with your needs
Experts in pDNA Cell Banking
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 Working and Master Cell Banks (WCB/MCB) in accordance with ICH requirements for viability, identity, and purity, laying the groundwork for production and upcoming regulatory filings.
All in all, our plasmid DNA cell banking services include:
Research Cell Bank Generation if necessary for your project
MCB & WCB Generation and Manufacturing
Full Characterization Services
Long Term Storage in our GMP controlled area
E. coli for your pDNA Cell Bank
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.