The Significance of Cell Banking
Microbial cell bank plays a key role in the production of biologics, such as vaccines, therapeutic proteins, peptides, enzymes, antibody fragments, and plasmid DNA (pDNA). It ensures a consistent and reliable supply of well-characterized microbial 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 cell banking, microbial strain libraries, microorganism bank, bacteria bank, fungal bank, yeast bank, strain storage
Application: human medicine production, animal medicine manufacturing, vaccine manufacturing, synthetic biology, recombinant large molecule biologics production, recombinant biologics manufacturing, biological reagent production
Microbial Cell Banking Services of Yaohai Bio-Pharma
We are experienced in microbial cell bank development, such as,
Bacteria: Escherichia coli (E. coli)
Yeast: Pichia pastoris (P. pastoris), Saccharomyces cerevisiae (S. cerevisiae), Hansenula polymorpha (H. polymorpha)
Our microbial cell banking services 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.
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