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pDNA Cell Banking Services
Build a reliable starting point for plasmid DNA production with tailored E. coli cell bank generation, characterization and long-term storage.
Cell banking secures a stable, traceable starting point for every batch that follows in your plasmid DNA pipeline.
Overview
Reliable Cell Banks for pDNA Manufacturing
Our team tailors the cell banking strategy to your quality requirements, project timeline and manufacturing goals. We support both non-GMP and GMP cell banking, including Master Cell Banks (MCB), Working Cell Banks (WCB) and End-of-Production Cell Banks (EOPCB), complete with phase-appropriate testing, documentation and long-term storage.
In addition, we can design and construct E. coli plasmids to meet specific client requirements or work with client-supplied plasmids. In either case, we generate E. coli cell banks to support subsequent plasmid DNA production.
One-Stop-Shop Solution for Your pDNA Cell Banking Needs
Cell Bank Generation
Generation of Research, Master and Working Cell Banks (MCB, WCB) for reliable and reproducible plasmid DNA manufacturing.
Full Characterization
Tailored analytical testing chosen around your pDNA application, ensuring that only the data your project needs is generated.
Long-Term Storage
Secure long-term storage for GMP and non-GMP E. coli cell banks under controlled conditions at <= 60ºC.
Process
How a Standard pDNA Cell Banking Project Works
01
Proposal Preparation
Together with the client, we define the cell banking scope, quality grade and testing plan around the pDNA manufacturing path.
02
Cell Bank Generation
Our team generates the required MCB and WCB under the agreed operational conditions.
03
Testing and Release
Our quality control team performs phase-appropriate characterisation before release.
04
Long-Term Storage
53Biologics stores approved banks under controlled conditions and keeps them ready for manufacturing.
Technical Specifications
Different analysis for different cell banks.
Every project is unique. Our analytical packages are tailored to provide only the testing your pDNA cell bank and application require.
| Analytical test | Non-GMP bank | GMP bank | |
|---|---|---|---|
| Purity | Determination of purity in microbial culture using differential / selective agars | ✓ | ✓ |
| Purity | Colony morphology assessment | ✓ | ✓ |
| Identity | Microbial identification by comparative sequence analysis of genomic DNA, e.g. 16S rRNA or equivalent | — | ✓ |
| Identity | Plasmid identity by restriction endonuclease analysis | ✓ | ✓ |
| Identity | Plasmid DNA sequencing, full plasmid or critical regions | — | ✓ |
| Identity | Selectable marker confirmation | ✓ | ✓ |
| Viability | Titer determination of microbial suspension, CFU/mL post-thaw | ✓ | ✓ |
| Stability | Plasmid retention in transformed host cells | — | ✓ |
| Stability | Restriction analysis/plasmids sequencing after passaging / stability challenge | — | ✓ |
| Stability | Plasmid copy number assessment, e.g. qPCR or ddPCR | — | ✓ |
| Safety | Lytic / lysogenic bacteriophage assay | — | ✓ |
| Safety | Absence of adventitious microbial contaminants, bacteria / yeast / mold as applicable | — | ✓ |
Why Choose 53Biologics for pDNA Cell Banking
Work Side
by Side
Direct access to our scientific team keeps bank generation and testing aligned with your plasmid and manufacturing requirements. Decisions are made together, with clear communication throughout the project.
Scientific Confidence from the Start
We apply scientific expertise to protect strain identity, purity, viability and genetic stability. A well-characterized cell bank provides a reliable and traceable starting point for consistent pDNA manufacturing.
Built Around
Your Program
Every cell bank can be tailored to your development stage, regulatory pathway and testing needs. The scope evolves around your program rather than forcing it into a fixed package.
Continuity into Manufacturing
Keep cell banking and pDNA production connected within one CDMO. Retaining knowledge, materials and documentation with the same team reduces transfer risk and supports smoother progression toward GMP and future supply.
Request a Quote for Your pDNA Cell Banking Project
Tell us about your plasmid DNA project and quality grade — our team will get back to you within as soon as possible.
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