Cell Banking
Establishment of high-grade stable cell banks are crucial for ensuring consistency and quality of the production process. Our GMP facilities are equipped with dedicated manufacturing facilities for microbial and mammalian cell bank construction and storage from Primary Cell Bank (PCB) and Master Cell Bank (MCB) establishment to generation of Working Cell Banks (WCB).
Microbial Cell Banking
uBriGene’s establishment of PCB, MCB and WCB for plasmid production and validation is performed in accordance to the highest industry standards. Our GMP facility is outfitted with dedicated microbial call banking construction and storage equipment enabling us to generate three-tired microbial cell banks with the highest regulatory standards for our clients.
Production Workflow
Production Technique Highlights
Strain Origin and Traceability
All strains are purchased from CICC with full traceability for quality assurances.
Clonal Stability
High quality plasmid construction and transformation to generate high expressor clones.
High Compliance Standards
All strains are verified and inspected to meet strict compliance and industry standards.
IND Application Ready
PCB, MCB and WCB are established to meet Investigational New Drug application standards.
Mammalian Cell Banking
uBriGene’s GMP facility have dedicated cell banking construction and storage laboratories providing high quality Primary Cell Bank (PCB), Master Cell Bank (MCB) and Working Cell Bank (WCB) services. uBriGene’s patented suspension 293XS and adherent 293TY cell lines are optimized for large-scale industrial production of viral vectors, such as AAV and lentivirus. All cell banks constructed are in accordance with the highest industry standards to ensure purity and stability.
Production Workflow
Production Technique Highlights
Proprietary Cell Line
Patented serum-free 293 cells optimized for high volume production.
Time Efficiency
Prior cell bank quality inspections and validation to save development time.
Traceable Documentation
Comprehensive cell bank document traceability.
Scalability
Linear scalability for cell culture of up to 500L volumes.
Quality Control and Assurance
With our one-stop shop solution to our client’s cell and gene therapy needs, we provide the highest quality QA and QC support. Our dedicated and experienced quality teams assist our clients in developing testing methods to meet even the most stringent requirements of GMP projects.