Typical Microbial Cell Bank Characterization Program

Assays for Master cell Bank,(MCB) Working Cell Bank (WCB) & End of Product (EOPC): 

• Bacteriophage:  Determination of bacterial virus by induction with chemicals or irradiation
• Purity/identity:  Determination of the presences of contaminating organisms and identity of the parental organisms
• Viability :  Determination of the number of viable organisms by enumeration
•  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 of the presences of any major alterations in the recombinant DNA over multiple generations
• Restriction Map :  Determination of the number of copies of construct in the host genome
• RNA Sequence Analysis  :  Determination of the sequence of the gene of interest to verify the consistency of the sequence over multiple generations
• RNA Sequence Analysis : Determination of the sequence of the transcript of the gene of interest to verify the consistency of the sequence over multiple generations