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Yeast Cell Line Testing
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