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CHO Cell Bank Testing
CHO Cell Bank Development Testing
Critical Quality Attributes
Assay
Description
Characterization
Northern blot for clone selection
Compare RNA expression profile between clones by Northern blot
RNA-Seq
Evaluate performance of clones
Southern blot for Clone Selection
Compare integration profile using Southern blot
Confirmation of clonality by Southern blot
Evaluate consistency of integration site(s) between cell bank clones
Characterization
Northern blot for clone selection
Compare RNA expression profile between clones by Northern blot
Integration site analysis by NGS
Identification of integration site(s) by targeted sequencing using Illumina or Nanopore NGS
mRNA Sequencing
RT-PCR Sequencing of transcribed target gene by Sanger
Protein expression
Evaluate target protein expression and quality
CHO Cell Bank Release Testing
Critical Quality Attributes
Assay
Description
Stability
Northern Blot
Confirm stability of transgene expression over time or for clone screening
Southern Blot- Integration Site analysis
Determine number of integration sites within cell bank and stability over time
Southern Blot- Confirmation of Structure
Confirm no large insertions or deletions within integrated transgene
Stability
Northern Blot
Confirm stability of transgene expression over time or for clone screening
Copy Number Analysis- QPCR
Quantitate number of integrated transgene copies per cell and stability over time by QPCR
Copy Number Analysis- ddPCR
Quantitate number of integrated transgene copies per cell and stability over time by ddPCR
mRNA Sequencing
RT-PCR Sequencing of transcribed target gene by Sanger
Viability Assay
Ratio of live to dead cells
Purity
Sterility Testing
Confirm sterility of cell bank
Mycoplasma Testing
Screen cell bank for presence of Mycoplasma