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Prokaryotic Cell Bank Construction

uBriGene 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

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Production Technique Highlights

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All strains are purchased from CICC and traceable

All strains are purchased from CICC and traceable

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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

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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

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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

uBriGene'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.

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