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Microbial Cell Banking Services
A fully integrated solution for your microbial cell banking needs. Our team works with you through all stages of cell bank manufacturing, from production to stability testing.
Cell banking secures a stable, traceable starting point for every batch that follows in your microbial pipeline.
This service is available also for:
Overview
A Reliable Foundation for Every Future Batch
Build a microbial cell bank that gives your program a consistent, well-characterized and traceable starting point for future manufacturing. Working side by side with your team, 53Biologics generates Research, Master and Working Cell Banks with a testing and release strategy shaped around the microorganism, process and intended use.
Our experience covers E. coli, P. pastoris and other BSL-1 and BSL-2 microbial hosts, including genetically modified, aerobic, facultative anaerobic and obligate anaerobic microorganisms. By connecting cell bank generation, characterization, storage and subsequent manufacturing within one team, we help protect process knowledge, reduce transfer risk and maintain continuity as your program progresses toward GMP production.
End-to-End Cell Banking Services for Your Protein Project
GMP and non-GMP Cell Banks
We generate non-GMP RCBs and GMP MCBs and WCBs to ensure a robust, traceable starting point for recombinant protein production.
End of Production Cell Bank
EOP cell banks generated to support genetic stability studies, process consistency and lifecycle management when required.
Full Characterization
Customized analytical testing aligned with your manufacturing stage, quality requirements and regulatory strategy.
Long-Term Storage
Controlled storage solutions that preserve the integrity and availability of your microbial cell banks throughout development and manufacturing.
Process
How a Standard Cell Banking Project Works
01
Proposal Preparation
Together with the client, we define the cell banking strategy: production strain, quality grade, testing requirements and intended manufacturing pathway.
02
Cell Bank Generation
We generate the required Master and Working Cell Banks (MCB/WCB) under controlled conditions for a consistent, traceable starting material.
03
Characterization
Each cell bank undergoes fit-for-purpose characterization, including microbiological and genetic testing appropriate to the intended quality grade before release.
04
Long-Term Storage
Approved cell banks are securely cryopreserved under monitored conditions, ensuring long-term integrity, traceability and availability.
Technical Specifications
Different Analysis for Different Cell Banks
Our analytical packages are tailored to your microbial cell bank and its intended use. The table below summarizes the testing typically performed for non-GMP and GMP banks.
| Analysis | Non-GMP cell bank | GMP cell bank |
|---|---|---|
| Purity & Identity | ||
| Purity of a microbial culture using differential / selective agars | ✓ | ✓ |
| Microbial identification by comparative sequence analysis of genomic DNA | — | ✓ |
| Expression construct confirmation by sequencing | — | ✓ |
| Plasmid restriction map / restriction endonuclease analysis | — | ✓ |
| Protein overexpression validation at flask scale | ✓ | ✓ |
| Viability | ||
| Titer / expression level estimate | ✓ | ○ |
| Safety | ||
| Lytic / lysogenic bacteriophage assay | — | ✓ |
| Stability | ||
| Bank stability study at storage temperature | — | ✓ |
| Retention of Selectable Markers in Transformed Host Cell Lines | — | ✓ |
| Retention of the Recombinant Construct in Transformed Strain | — | ✓ |
Every project is unique. Our analytical packages are tailored to provide only the testing your microbial cell bank and application require.
Why Choose 53Biologics for Microbial Cell Banking
Built Around Your Program
The bank type, quality level and testing strategy are defined around your microorganism and intended use. You get the scope your program needs without being forced into a rigid standard package.
Scientific Control from the Start
Our team applies microbial expertise to establish a consistent and well-characterized starting material. We include identity, viability, stability and growth performance tests. Direct access to the scientists involved provides clarity when technical decisions are required.
Adaptability That Protects Momentum
Microbial strains and development plans do not always behave as expected. We stay responsive as data emerges, adapting culture conditions, testing strategies and project scope to keep the banking program moving.
Continuity Into Manufacturing
Cell banking can remain connected to subsequent process development and GMP manufacturing within one partner. This preserves strain and process knowledge, reduces transfer risk and provides a clearer route as production needs grow.
Support
Frequently Asked Questions
Common questions about our microbial cell banking services. Can’t find what you need? Talk to our team.
Can 53Biologics generate both GMP and non-GMP cell banks?
Yes. We generate both non-GMP and GMP Master and Working Cell Banks, tailoring documentation, testing and quality systems to your project’s development stage and regulatory requirements.
What is the difference between a Master Cell Bank and a Working Cell Bank?
The Master Cell Bank is the primary, fully characterized stock of the production strain. Working Cell Banks (WCBs) are prepared from the MCB and used for routine manufacturing, preserving the integrity and long-term availability of the original bank.
Can you work with my existing production strain?
Yes. We can receive client-developed microbial strains and adapt the cell banking strategy to your manufacturing and regulatory objectives.
Which microbial hosts does 53Biologics support for cell banking?
We generate cell banks for a wide range of microbial expression systems, including E. coli, Pichia pastoris, Bacillus spp. and selected fungal hosts. Additional microbial platforms can also be evaluated depending on your project requirements.
Do you support both BSL-1 and BSL-2 microorganisms?
Yes. Our facilities are equipped to support microbial cell banking projects involving both BSL-1 and selected BSL-2 microorganisms, following appropriate biosafety procedures and containment requirements. Project suitability is assessed during the technical evaluation phase.
Request a Quote for Your Microbial Cell Banking Project
Tell us about your production strain and quality grade — our team will get back to you as soon as possible.
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