Yeast Cell Line Testing

Yeast Cell Bank Testing ensures the quality and consistency of yeast used in biopharmaceutical production. These methods are critical for both integrated and non-integrated yeast cell banks. Compliance with these standards is essential for the approval and ongoing quality assurance of biopharmaceutical products.

Yeast Cell Bank Development Testing

Critical Quality Attributes

Assay

Description

Characterization

Southern Blot- Clone Screening

Screen clones for number of unique genomic integrations

Identity

Sequencing – Sanger

Confirm full or partial yeast sequence by Sanger sequencing

Sequencing – NGS

Confirm full or partial yeast sequence by NGS

Yeast Cell Bank Release Testing

Critical Quality Attributes

Assay

Description

Identity

Sequencing – Sanger

Confirm full or partial yeast sequence by Sanger sequencing

Sequencing – NGS

Confirm full or partial yeast sequence by NGS

Content

Plasmid Copy Number Analysis

Determine number of episomal copies of transgene per cell by QPCR or ddPCR

Southern Blot- Integration Site analysis

Determine number of integration sites within cell bank and stability over time

Integrated Gene Copy Number Analysis

Determine number of integrated copies of transgene per cell by QPCR or ddPCR

Content

Plasmid Copy Number Analysis

Determine number of episomal copies of transgene per cell by QPCR or ddPCR

Marker Retention

Determine percentage of cells capable of maintaining selectable marker/plasmid

Inserted Gene Sequence Confirmation

Confirm full or partial yeast sequence by Sanger sequencing

Purity

Sterility Testing

Confirm sterility of cell bank

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