1883829840

Test	Host train	MCB	WCB
Identity and purity
Viability	+	+	+
Bacterial strain characteristic	+	+	-
Genotyping/phenotyping	+	+	-
Plasmid presence:
• plasmid DNA seąuencing	-	+	-
• copynumber	-	+	+
• restriction map	-	+	+
• the percentage of cells maintaining the plasmid	-	+	+
Adventitious agents
Purity by plating	+	+	+
Presence of bacteriophages	+	+	-

“+” - means the necessity of performing the test for the bank - means the test is not reąuired for the bank

The tests reąuired on each stage of manufacturing in reference to host strain, master celi bank (MCB) and working celi bank (WCB) (acc. to Polish Pharmacopea, XI-th ed. (2017) [19]).