CHO Cell Bank Testing

Chinese hamster ovary (CHO) cells have been extensively used in the biotechnology and pharmaceutical industries for several decades, primarily for the production of therapeutic proteins and biopharmaceuticals. Quality control (QC) of CHO cell banks is crucial in biopharmaceutical manufacturing to ensure the safety, purity, and consistency of the cell lines used for therapeutic protein production.

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

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