All Categories
ENEN
E. coli Cell Banking

E. coli Cell Banking

Home >  IVT RNA  >  mRNA CDMO  >  E. coli Cell Banking

IVT RNA

E. coli Cell Banking

The Significance of Cell Banking

Microbial cell bank plays a key role in the production of plasmid DNA (pDNA), which is an improtant raw material for mRNA production. Cell banking ensures a consistent and reliable supply of well-characterized Escherichia coli (E. coli) strains throughout the product lifecycle.

Based on the regulatory guidelines, the Master Cell Bank (MCB) and Working Cell Bank (WCB) are generated under GMP conditions. The microbial cell banks should be fully characterized following The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH Q5 Parts A, B, and D).

Keywords: microbial bank preparation, cell bank preparation, cell bank production, primary cell bank, master cell bank, working cell bank, strain bank establishment, microbial strain banking, microbial strain libraries, microorganism bank, bacteria bank, E. coli bank, strain storage

Application: plasmid DNA and mRNA production, human medicine production, animal medicine manufacturing, vaccine manufacturing

E. coli Cell Banking Services of Yaohai Bio-Pharma

We are experienced in microbial cell bank development, including bacteria E. coli for plasmid DNA manufacturing. Our one-stop microbial cell banking solutions include:

  • Primary cell bank (PCB);
  • Master cell bank (MCB), GMP-compliant facility;
  • Working cell bank (WCB), GMP-compliant facility;
  • Cell bank storage (freezer, liquid nitrogen, or freeze-drying);
  • Cell bank characterization: release testing and stability studies.
Service Details
Services Service Details Minimum timeline/day Deliverables
Primary cell banking, PCB Growth curve detecting 5 50-200 vials, Records
Strain subculturing and dispensing
PCB characterization TBD COA
Master cell banking, MCB Strain subculturing and dispensing 4 100-300 vials, Records
MCB characterization TBD COA
Working cell banking, WCB Strain subculturing and dispensing 4 100-300 vials, Records
WCB characterization TBD COA
Microbial cell banks storage Ultra-low freezers (-70°C) NA Temperature records
Liquid nitrogen (-150°C)
Freeze-drying
Features of Our Services

We offer one-stop microbial cell bank solutions, including PCB, MCB, and WCB manufacturing, full characterization (QC), and release (QA).

MCB and WCB are generated in our independent GMP workshop, Animal Origin Free, to effectively avoid contamination.

We offer long-term storage options, with multiple strain preservation methods, such as ultra-low freezers, liquid nitrogen, and freeze-drying (lyophilization). Strain banks are stored at two different locations.

Our Experiences

Yaohai Bio-Pharma has more than 14 years of experience in microbial cell banking and characterization. We have delivered more than 100 well-characterized cell banks to our global customers, of which 7 have been approved for clinical trials.

Successful cell banking is critical in the biological lifecycle. Our cell banking services can be used as a stand-alone service, or as an integral part of process development and/or GMP manufacturing projects.

Get a Free Quote

Get in touch