Typical Microbial Cell Line
Assays for Master Cell Bank (MCB), Working Cell Bank (WCB) and End of Product Cells (EOPC):
- Culture identity:
- Cellular morphology to be determined by the Gram stain
- Genetic identity to be determined by PCR analysis and sequencing of 25-28S rRNA
- Bacteriophage detection: Determination of bacterial virus by induction with chemicals or irradiation
- Purity/Identity Testing: Determination of the presence of contaminating organisms and identity of the parental organisms
- RT Assay F-PERT: Retroviral infectivity assay for use when highly sensitive qualitative fluorescent results are required for vaccine seed or bulk produced in human cell substrates
- Replication Competent Retrovirus: Determination of the presence of replication competent retroviruses (RCR) in gene therapy products intended for human use
- Replication Competent Adenovirus: detection of replication-competent adenovirus
- Viability: Determination of the number of viable organisms by enumeration (CFU assay/colony counting)
- Genetic stability
- Retention of the selectable markers: Determination of the plasmid stability using selectable and non-selectable media
- Retention of the recombinant construct: Determination of the stability of construct over several generations
- Copy number determination: Determination of the presence of any major alterations in the recombinant DNA over multiple generations
- Restriction map analysis: Determination of the number of copies of construct in the host genome
- Sequence integrity of the gene of interest
- RNA sequence analysis: Determination of the sequence of the gene of interest to verify the consistency of the sequence over multiple generations
- RNA transcript sequence analysis: Determination of the sequence of the transcript of the gene of interest to verify the consistency of the sequence over multiple generations
- DNA sequence analysis: Determination of the sequence of the gene of interest to verify the consistency of the sequence over multiple generations
Submission Forms
Microbial-Yeast Cell Bank Characterization Form (ZZ)