Biologics Testing - Working Cell Bank
A Working Cell Bank may often be created from the Master Cell Bank at the start of a project for Biologics and as with the Master Cell Bank, testing for Identity, Purity and Stability are required.
|Morphology light microscopic observations||To determine the morphology and assess the stability of the same characteristics of the cells during culture.|
|DNA Fingerprinting||The purpose of this assay is to demonstrate the genetic similarity or differences between cell banks using the cellular DNA. The procedure is based on the Random Amplified Polymorphic DNA (RAPD) analysis method. This assay is useful when comparing a new MCB with an existing MCB or to compare MCB with End of Production cells.|
|Sterility Test||The sterility test is designed to detect a wide range of bacteria and fungi and is used to ensure the cell bank is free from microorganisms. The test may require qualification.|
|Detection of Mycoplasma by broth, agar and in vitro cell based methods||The mycoplasma test is designed to detect a wide range of mollicutes that may be present in a cell bank. A qualification of the test is required to ensure that the presence of the cell bank and associated components do not interfere with the detection of mollicutes. The US test specification is different for this test.|