GMP-compliant manufacturing and characterization of mammalian and microbial cell banks, aligned with regulatory standards.
Master, working, and end-of-production cell banking services are available based on our clients’ specific needs. In addition to custom GMP cell banking, uBriGene offers client access to qualified iPSC cell banks and 293 suspension cell banks to support AAV and LVV GMP manufacturing.
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Automated closed-system technology for manufacturing ensures sterility with functionally closed disposables, minimizes operator errors through pre-programmed steps, and enhances consistency by reducing variability. It also reduces technician hands-on time and lowers production costs.
Over 100 cell banks successfully manufactured and released
Extensive GMP cell banking experiences
GMP qualified
High productive cell lines
Active DMF with FDA
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Our GMP cell banking services support mammalian (HEK293, iPSC, MSC and more), microbial, and virus banking, providing key raw materials for advanced cell and gene therapy development. Our cell banking, any required process and analytical method development, and GMP manufacturing are performed in compliance with the highest regulatory standards.
We manufacture and release Master Cell Banks (MCB), Working Cell Banks (WCB), Research Cell Banks (RCB), and End-of-Production Cell Banks (EOP CB) using well-established protocols and testing packages. Full quality release assays and stability studies are performed in-house, ensuring that the cell banks meet the highest regulatory standards.
The advantages of membrane matrix in downstream chromatography for plasmid purification include requiring only 30% of the time compared to conventional resin. Therefore, plasmid DNA is manufactured faster and at a much lower cost.
uBriGene’s QC and analytical teams can support the development of cell bank-specific analytical methods, routine cell bank characterization, QC release, and stability testing using well-established in-house assays.
| Assays | Methods |
|---|---|
| Colony appearance | Culture method |
| Viability | Plate culturing |
| Gram staining | Gram staining |
| 16S rRNA | 16S rRNA |
| Phage detection | Phage plaque detection |
| Antibiotic resistance | Plate culturing |
| Plasmid retention rate | Plate culturing |
| Plasmid copy number | qPCR |
| Restriction enzyme profile | DNA Gel electrophoresis |
| DNA sequencing | Sanger sequence |
*Outsourced testing
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| 6 | 12 | 18 | 24 | 36 | 48 | 60 | |
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*Outsourced testing
| Test Item | Method | |
|---|---|---|
| Physical / Chemical Properties | Appearance | Visual inspection |
| Identity | Cell Identification | Short Tandem Repeat (STR) profiling |
| Cytogenetic Analysis | Karyotyping | |
| Strength | Cell Growth and Morphology | Microscopic observation and growth curve analysis |
| Cell Viability | Cell counter | |
| Functional Assays | TBD | |
| Safety | Sterility | Sterility Testing (Membrane Filtration) |
| Mycoplasma Testing | Direct Inoculation (with Method Confirmation) | |
| Adventitious Virus Testing | In Vitro Different Cell Inoculation Methods (Vero, MRC-5, HEK293, CHO) | |
| In Vivo Animal & Chick Embryonated eggs | ||
| Retrovirus Testing | Reverse Transcriptase Activity Test (PERT) | |
| Infectious Test (Culture Method) | ||
| Transmission Electron Microscopy (cell) | ||
| Species Specific Viruses Testing | 9 CFR Part 113, qPCR |
*Outsourced testing
Our fully qualified 293XS cell bank is specifically selected for its exceptional productivity and quality in AAV vector manufacturing, helping to reduce costs for your clinical therapeutic programs.
Serum-free, animal component free
Good Growth at density of 1E7 cells/mL
High AAV productivity, 1E14 vg/L
DMF on file with the FDA
GMP AAV production received FDA IND clearance
Scalable AAV production up to 2,000 L.
Our fully qualified 293TH cell bank has been selected for its high productivity and quality in lentiviral vector production, translating to lower costs for your clinical therapeutic programs. The suspension lentivirus production platform is serum free and much easier to scale up.
Fig. 1. Comparison of lentivirus productivity of HEK293T adherent cells and uBriGene’s 293TH suspension cells. Four different GOIs were used for this study. The transduction units were analyzed using flow cytometry after transducing Jurkat cells with the lentiviral vectors produced from HEK293T adherent cells and our suspension 293TH cells.
Our fully qualified 293TH cell bank has been selected for its high productivity and quality in lentiviral vector production, translating to lower costs for your clinical therapeutic programs. The suspension lentivirus production platform is serum free and much easier to scale up.
US sourced somatic cell derived iPSC cell banks
Generated using uBriGene’s iPSC reprogramming cocktail mRNA-LNP with no genome disruption
Fully GMP qualified
Critical materials for allogeneic cell therapy programs
Fig. 2. Detection of pluripotency identification markers for uBriGene’s iPSC cell bank, including SSEA4, TRA-1-81, Sox2, and Nanog, using flow cytometry.
Unveil the current manufacturing approaches for LVV and its deployment in cell therapies.
Discover our AAV manufacturing capabilities, scalable processes, and testing platform.
Learn about CAR-T production process & regulatory guidelines.
Discover our GMP iPSC manufacturing process and testing.
Access to uBriGene’ s qualified mammalian cell banks is available with cost effective terms if the sponsor manufactures the viral vectors with uBriGene’s CDMO services. Drug master files are active for the 293XS and 293TH master cell banks with the FDA helping clients reduce time during their regulatory filings.
Our experience with engineered cell lines includes a variety of mammalian cell types including those used to produce oncolytic viral vectors and iPSC cells engineered from fibroblasts.
uBriGene uses outside vendors for a limited number of release tests primarily focused on the adventitious agent test panel requirements.
GMP Cell banking involves creating a repository of cells (Master cell bank, Working cell bank, and End-of-Production Banks) that serve as a consistent and reliable source for biologics manufacturing. It ensures product consistency, traceability, and safety for long-term use in clinical and commercial applications.
Microbial cell banks support processes like plasmid and recombinant protein production, typically involving bacterial or yeast strains. Mammalian cell banks are used for producing complex biologics like monoclonal antibodies, viral vectors, and gene therapies, involving CHO, HEK293, or other mammalian cell lines.
We provide comprehensive documentation, including certificates of analysis, batch records, and regulatory support documents. These materials assist with clinical trial applications and regulatory filings.
Establishing an MCB can take anywhere from several weeks to a few months, depending on the complexity of the cell line and the specific testing required.
The MCB is the primary repository of cells and is used to create Working Cell Banks (WCB), which are employed during production. The MCB is usually preserved for long-term use, while WCBs are used more regularly in manufacturing processes.
Outsourcing GMP cell banking to a CDMO ensures access to expert facilities, compliance with global regulatory standards, and reduced time to market. It also provides flexibility and scalability for biologics manufacturing projects.
Extensive expertise with a track record of successfully releasing over 60 GMP batches of AAV.
Over 50 cell banks are manufactured in compliance with regulatory standards.
Proactive scientific and regulatory support
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Ask the plasmid DNA expert! With over 300 GMP batches in our track record and our cost-effective platform technology, we can help accelerate your clinical programs.
