Prokaryotic Cell Bank Construction
BriGene establishes primary cell bank (PCB), the main cell bank (MCB) and the working cell bank (WCB) for plasmid production, and the inspection of the prokaryotic cell bank is completed in accordance with industry standard. Our GMP plant is equipped with dedicated suites for prokaryotic cell bank construction and storage, which enable us to build a three-tiered prokaryotic cell bank that meets regulatory requirements for our clients.
The establishment of a highly stable prokaryotic cell bank is crucial for ensuring the consistency of the production process. Our GMP plant is equipped with dedicated suites for prokaryotic cell bank construction and storage, which enable us to provide PCB, MCB and WCB construction and storage services. All GMP prokaryotic cell banks are identified and verified in accordance with the requirements of the industry standard to ensure quality and stability.
Production Workflow
Production Technique Highlights
All strains are purchased from CICC and traceable
All strains are purchased from CICC and traceable
Stable monoclonal strains with high gene expression levels
Based on the DNA sequence provided by the client, through plasmid construction and transformation, stable monoclonal strains with high gene expression levels are selected
All strains are verified and inspected in compliance with the requirements of industry standards
All strains are verified and inspected in strict accordance with the requirements of industry standards
Established of MCB and WCB after PCB verification to meet IND application requirements
MCB and WCB are established after PCB is verified to meet IND application requirements
Quality Control and Quality Assurance
BriGene's one-stop gene therapy drug CDMO service platform has rigorous and professional QA and QC teams. We help you with developing testing methods for gene therapy products to meet the testing requirements of all GMP projects. The bacterial prokaryotic cell bank has been tested in accordance with industry standards. The testing items and methods are listed below.