Cell Banking

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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 Manufacturing if necessary for your project
  • MCB & WCB Generation and Manufacturing
  • Full Characterization Services
  • Long Term Storage in our GMP controlled area

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E. coli for your pDNA Cell Bank

Our team has a deep expertise in microbial cell banks, particularly in E. coli strain 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.

Our team works with you through all stages of cell bank manufacturing, from the initial inquiry to the characterization, storage and stability testing

Discover more about 53Biologics pDNA Services

Process Development

We optimize both USP and DSP to speed up timelines for your pDNA delivery.

Contract Manufacturing

Our team can provide custom plasmid production that fits your project specifications.

Analytics

Our pDNA services comes with outstanding quality control and documentation support as requested.

Are you interested in our pDNA cell banking services?