GMP Plasmid Production Cell Bank Establishment

Establishing a cell bank is a key step in GMP plasmid production. Creative Biogene has extensive experience in GMP plasmid production cell library construction. We can provide our clients with tertiary production cell bank construction, continuous transmission stability study and plasmid expression stability study services. We can rapidly build GMP plasmid production cell banks with the target gene sequence provided by the client.

Specific Services

Creative Biogene's GMP facility has a separate strain bank preparation room and a separate storage room. We have a comprehensive cell bank management protocol and are equipped with advanced testing equipment and an experienced testing team. These ensure that we can provide customers with regulatory-compliant preparation and preservation services for PCB, MCB, and WCB three-tier strain banks, as well as seed bank strain passaging and storage stability studies to ensure safe, stable, and reliable delivery of strains to customers, realizing one-stop R&D service demands from gene sequences to plasmid GMP production cell banks.

Primary cell bank establishment (PCB): The master cell bank derives all working cell banks. The master cell bank derives all working cell banks. We can help our customers build characterized and validated primary cell banks.
Master cell bank (MCB): Main cell bank preserved after passaging and amplification from the primary cell bank. We can assist customers in establishing fully characterized master cell banks to specific quality control requirements.
Working cell bank (WCB): The working cell bank is saved after batch passaging and amplification from the main cell bank.
Cell bank quality testing and stability research.

Process of Plasmid Production Cell Bank Establishment

What We Deliver

Services	Details	Deliverables	Turnaround Time
PCB establishment	GMP record writing Aseptic inspection Mycoplasma detection Endogenous and exogenous virus contamination test Tumorigenicity test	Report on 20 PCB cell banks
MCB establishment	MCB cell recovery curve GMP record writing Mycoplasma testing Sterility check Endogenous and exogenous virus contamination test Tumorigenicity test Cell function test	Report on 50 MCB cell banks; MCB cell recovery data.	6-7 weeks
WCB establishment	WCB cell recovery curve GMP record writing Aseptic inspection Endogenous and exogenous virus contamination test Cell function test	Report on 200 WCB cell banks; WCB cell recovery data.	3-4 weeks

Why Choose Us?

Customized services

According to the gene sequence provided by customers, we screen stable and high expression strains by professional codon optimization, recombinant plasmid construction and expression strain construction. In addition, we can also provide customized plasmid architecture model to effectively improve product yield.

Independent cell bank establishment facility

We can effectively avoid the risk of contamination and establish a GMP-compliant MCB, WCB, and perfect cell banking management protocols that are safe, reliable, and in compliance with FDA regulatory requirements.

Quality control

All cell banks are tested and released according to the standard requirements to ensure purity, stability, etc. Preservation services for PCB, MCB, WCB are available. Cell bank construction is followed by passaging and storage stability testing to ensure stable strains and high-quality delivery.

Creative Biogene is committed to providing one-stop services from plasmid strain construction, clone screening to cell bank establishment to accelerate our customers' GMP plasmid production process. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

* For research use only. Not intended for any clinical use.

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