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Mammalian Cell Banking Services
Generate robust cell banks for recombinant protein production with a strategy aligned to your development stage, manufacturing goals and regulatory pathway.
Cell banking secures a stable, well-characterized starting point for every batch that follows in your mammalian pipeline.
This service is available also for:
Overview
Cell Banking That Supports the Entire Manufacturing Process
A well-characterized mammalian cell bank provides the controlled, traceable starting material needed for consistent process development and manufacturing. 53Biologics supports flexible banking strategies, whether you already have a production cell line or Research Cell Bank (RCB) that must be transferred into a GMP-compliant Master Cell Bank (MCB) and Working Cell Bank (WCB), or your program requires cell line development and banking from the beginning.
Our team defines the appropriate bank structure, quality level, characterization strategy and documentation package according to your development stage and future manufacturing requirements. By connecting cell line development, cell banking, process development and GMP production under one coordinated program, we help protect cell line history, reduce transfer risk and create a reliable foundation for clinical and commercial supply.
End-to-End Cell Banking Services for Your Protein Project
From Existing Cells to GMP Banks
Start from an established production clone or Research Cell Bank and progress toward qualified Master and Working Cell Banks. The banking strategy is adapted to the cell line history, available documentation and future manufacturing requirements.
Risk-Based Characterization
Characterization packages are defined according to the development phase, cell line and intended use. Identity, sterility, mycoplasma, viability and genetic stability testing provide the evidence needed without adding unnecessary analytical activities.
Traceable Supply Continuity
Controlled cryopreservation, monitored storage and complete cell bank traceability help protect access to critical starting material throughout development, clinical manufacturing and future supply campaigns.
Designed for What Comes Next
Cell banking is planned with process development, scale-up and GMP manufacturing in mind. Connecting these stages early helps preserve cell line knowledge, simplify transfers and avoid repeating work as the program advances.
Process
Our Cell Banking Workflow
01
Proposal preparation
We assess your starting point, whether you already have an established production cell line or are beginning from an early development stage, to define the most appropriate cell banking strategy.
02
Cell Bank Generation
Master and Working Cell Banks (MCB/WCB) are generated under controlled conditions to provide a consistent and traceable starting material for recombinant protein production.
03
Characterization & Release
Comprehensive release testing is conducted to ensure the cell bank meets predefined quality, traceability and regulatory requirements.
04
Long-Term Storage
Released banks are securely stored and made available to support process development and GMP manufacturing as your program advances.
Technical Specifications
Different Analysis for Different Cell Banks
Our analytical packages are tailored to your mammalian cell bank and its intended use. The table below summarizes the testing typically performed for non-GMP and GMP banks.
| Test / Characterization | Non-GMP cell bank | GMP cell bank |
|---|---|---|
| Cell line identity | ||
| Host cell line identity / species confirmation | ✓ | ✓ |
| DNA barcoding / genetic identity of host cell line | ○ | ✓ |
| Cell morphology / growth characteristics | ✓ | ✓ |
| Clone history and traceability documentation | ✓ | ✓ |
| Monoclonality evidence / clone derivation report, when applicable | ○ | ✓ |
| Genetic identity | ||
| Expression cassette / gene of interest confirmation by sequencing | ✓ | ✓ |
| Recombinant product integrity by Sanger sequencing or equivalent | ✓ | ✓ |
| Vector / plasmid map and annotated construct information | ✓ | ✓ |
| Copy number / integration pattern | ○ | ○ |
| Genetic stability after passages / population doublings | ○ | ✓ |
| Viability | ||
| Viable cell concentration / viable cell density | ✓ | ✓ |
| Post-thaw viability assessment | ✓ | ✓ |
| Post-thaw recovery / growth kinetics | ✓ | ✓ |
| Viability testing of beginning / middle / end bank vials | ○ | ✓ |
| Productivity | ||
| Expression confirmation at small scale | ✓ | ○ |
| Titer / expression level estimate | ✓ | ○ |
| Product quality check after small-scale expression (SDS-PAGE, SE-HPLC, Octet/ELISA, as applicable) | ○ | ○ |
| Microbiological safety | ||
| Sterility testing | ✓ | ✓ |
| Bacteriostasis / fungistasis suitability testing, if required | ○ | ✓ |
| Mycoplasma detection | ✓ | ✓ |
| Viral safety | ||
| In vitro adventitious virus assay | — | ✓ |
| Retrovirus / reverse transcriptase-related testing (e.g. PBRT) | — | ✓ |
| Ultrastructural evaluation by TEM | — | ✓ |
| Species-specific adventitious agent testing (e.g. bovine / porcine agents) | — | ✓ |
| Additional viral safety assays (e.g. MVM qPCR or extended panels), if required | — | ○ |
| Biosafety | ||
| BSL / GMO risk assessment documentation | ○ | ✓ |
| Storage | ||
| Storage under controlled temperature conditions | ✓ | ✓ |
| Continuous temperature monitoring / alarmed storage | ✓ | ✓ |
| Long-term cell bank storage report / inventory record | ○ | ✓ |
| Stability | ||
| Bank stability study at storage temperature | — | ○ |
| Post-storage viability / recovery testing at defined timepoints | — | ○ |
| Documentation | ||
| Certificate of Testing / characterization report | ✓ | — |
| Certificate of Analysis | — | ✓ |
| Cell bank manufacturing report / batch record | ✓ | ✓ |
| Raw material and consumable traceability | ○ | ✓ |
| GMP manufacturing documentation package | — | ✓ |
| QA review and GMP release | — | ✓ |
| Method qualification / verification / validation status | ○ | ✓ |
| Deviations / CAPA summary, if applicable | ○ | ✓ |
The final characterization package is defined according to the specific need of each project. Additional or confirmatory testing may be added if necessary.
Why Choose 53Biologics for Mammalian Cell Banking
A Banking Strategy Built Together
Work directly with our team to define the bank structure, characterization scope and documentation requirements. Close collaboration keeps the banking strategy aligned with your cell line history and future manufacturing plans.
Confidence in Your Starting Material
Scientific and quality oversight supports the generation of traceable, well-characterized mammalian cell banks. Risk-based testing helps confirm identity, purity, viability and suitability for consistent manufacturing.
Flexible from Any Starting Point
Begin with an existing production clone, an RCB requiring progression to GMP MCB/WCB, or a new cell line developed from the ground up. The scope adapts to your available material and program stage.
Continuity into GMP Manufacturing
Connect cell banking with process development, scale-up and GMP production through one coordinated program. Preserving cell line knowledge and documentation across stages reduces transfer risk and avoids unnecessary repetition.
Support
Frequently Asked Questions
Common questions about our mammalian cell banking services. Can’t find what you need? Talk to our team.
Which mammalian cell lines do you support?
We support projects based on CHO and HEK and sometimes other production cell lines (i.e. VERO) depending on the project characteristics and regulatory requirements.
Can I transfer my existing production cell line to 53Biologics?
Yes. We can receive client-developed production cell lines (Research Cell Banks) and start the generation of Master and Working Cell Banks when required.
Can 53Biologics generate GMP Master and Working Cell Banks?
Yes. We coordinate the generation of qualified GMP Master and Working Cell Banks with the documentation and testing required to support clinical and commercial manufacturing.
Do you provide long-term storage?
Yes. Qualified cell banks can be cryopreserved under controlled conditions and managed throughout the lifecycle of your manufacturing program.
What information do you need to start a cell banking project?
Projects can start at different stages of development, from an initial protein expression concept requiring cell line development to an established production cell line or existing Research Cell Bank (RCB). Based on your starting point, manufacturing objectives and regulatory pathway, we define the appropriate scope of work and recommend the most suitable cell banking strategy.
Request a Quote for Your Mammalian Cell Banking Project
Tell us about your production cell line and quality grade — our team will get back to you as soon as possible.
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