Cell bank characterization

Characterization of cell banks used for development and manufacturing of therapeutic products is required by regulatory agencies world-wide. Avance Biosciences offers a variety of genomic services to test the identity, purity, and genetic stability of the cell banks. Services are offered  at research grade, or under GLP or cGMP regulations.
Non-integrated Cell Bank Tests
Following assays are offered for characterization of non-integrated cell banks.
 Service Description
API 20 Test The API 20E test kit from bioMerieux, Inc, in addition to the oxidase test is offered for the identification of E. coli and other enteric bacteria at the species level.
16S rRNA Sequencing DNA sequencing of highly conserved 16S rRNA gene is performed as part of cell line identity tests for the identification of E. coli and other enteric bacteria at the species level.
Viability Testing Services are performed to determine the percent of live cells in a cell bank sample.
Gram Staining Test Evaluating the identity and purity of microbial cell lines.
Bacterial and Fungal Impurity Test Evaluating the purity of microbial cell lines from bacterial and fungal contaminants in both aerobic and anaerobic environments.
E. coli Strain Identity Testing Plating cell bank samples and controls under certain conditions for identity test of E. coli DH10B, K12, and B Strain.
Bacteriophage Testing Services are designed to test the presence or absence of lytic phage and prophage contaminants in bacterial cell banks.
Marker Retention Testing This service is offered to determine the percentage of cells in a cell line sample that contain a selectable marker such as antibiotic resistance.
Sequencing of Plasmid Construct High quality DNA sequencing with a 2-fold coverage on both DNA strand is offered as part of cell line identity and stability tests.
Copy Number Analysis by qPCR This service determines the average copy number of a plasmid in a cell. The ABI 7900HT Sequence Detection System is used to measure the quantities of the plasmid and the host DNA present in a cell line sample. Custom assays are often developed and validated per ICH guidelines to detect specific target genes.
Restriction Fragment Analysis Restriction Enzyme Analysis is used to evaluate genetic stability of a plasmid construct by evaluating the restriction profile in comparison to a reference.
Integrated Cell Bank Tests
Following assays are offered for characterization of integrated cell banks.
 Service Description
Sequencing of Expression Construct High quality cDNA sequencing with a 2-fold coverage on both DNA strand is offered as part of cell line identity and stability tests.
Copy Number Analysis by qPCR This service determines the average copy number of a integrated gene construct in a cell. The ABI 7900HT Sequence Detection System is used to measure the quantities of the target specific gene and the host DNA present in a cell line sample. Custom assays are often developed and validated per ICH guidelines to detect specific target genes.
Structure Analysis by Southern Blot Restriction enzyme digestion of cell line DNA followed by Southern blotting is used to evaluate genetic stability of the integration site of an expression construct. Both integration site number and structure will be determined and may be compared to a reference if available.
Transcript Analysis by Northern Blot This service is offered to detect the presence of an expressed transcript containing a sequence of interest. The size of the transcript will be estimated and the presence of partial transcripts will be reported.

 

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