The Significance of Cell Bank Characterization
Well-characterized cell banks are critical for the batch-to-batch consistency of manufacturing process and biologics quality, including identification and stability. The objective of the identification testing is to confirm the identity, purity, and suitability of the cell substrate. And the stability studies are done to ensure a reliable supply of cells for long-term manufacturing use.
The current regulatory guidelines such as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH Q5 Parts A, B, and D), suggest how to characterize the cell banks.
Microbial Cell Bank Characterization Services of Yaohai Bio-Pharma
Our cell bank characterization services include:
- Identity and purity of microbial cells, e.g., colony formation, auxotrophy, antibiotic resistance, staining, 16S/18S rRNA or Internally Transcribed Spacer (ITS) sequencing.
- Identity of target gene, e.g., plasmid or target gene sequencing, restriction enzyme digestion, copy number, target protein/plasmid analysis.
- Stability studies, e.g., genetic stability and storage stability.
We are experienced in microbial cell bank characterization, such as,
Bacteria: Escherichia coli (E. coli)
Yeast: Pichia pastoris (P. pastoris), Saccharomyces cerevisiae (S. cerevisiae), Hansenula polymorpha (H. polymorpha)
Service Details
| Services | E. coli Cell Bank Characterization | Yeast Cell Bank Characterization |
| Identity and purity | Colony formation | Colony formation |
| Microbial enumeration | Microbial enumeration |
| Marker Retention Testing:auxotrophy, antibiotic resistance, etc. | Marker Retention Testing:auxotrophy, antibiotic resistance, etc. |
| Gram Staining | Staining |
| Biochemical assays | Biochemical assays |
| 16S rRNA sequencing | 18S rRNA sequencing |
| - | Internal Transcribed Spacer (ITS) sequencing |
| Electron microscopy | Electron microscopy |
| Bacteriophage detection | - |
| Target gene detection | Plasmid retention rate | Detection of integration of target gene into host genomic DNA |
| Vector copy number | Copy number |
| Target gene sequencing | Target gene sequencing |
| Plasmid sequencing | - |
| Restriction endonuclease mapping | - |
| Test production (flask culture) | Test production (flask culture) |
| Stability Studies | Genetic stability | Genetic stability |
| Storage stability | Storage stability |
Related Service:
Microbial Cell Banking
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