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DNA Qualification
Pall Life Sciences - BioPharmaceuticals
•Datasheet: DNA Qualification
Along with the availability of improved membrane purification technologies related to contaminant clear¬ance for the production of biomolecules from mammalian cell culture, Pall has developed methodologies for the quantification of DNA in order to validate DNA clearance.
Objectives
In order to obtain high product yields, cells are now grown to very high densities. This leads to high levels of cell death and lysis. The end result is that some biomolecule preparations contain very high levels of cell debris, of which DNA is of particular concern as a potential carcinogenic. The FDA Center for Biological Evaluation and Research in the USA defines the maximum allowable nucleic acid contamination as 10 pg per dose.
To gain regulatory acceptance of any production processes, a company must install and validate methods for DNA removal either through testing for DNA content in the final product for every batch or through dem¬onstrating DNA removal at every stage in each of three pilot and three full-scale production runs.
DNA Quantification Method
A number of DNA quantification tests exist and have been validated by the industry.
Pall has chosen to develop a hybridization-based test, based on the ability of two complementary strands of DNA to hybridize and form a double helix, that uses radio-labelled probes.
Test Summary
- Determination of appropriate DNA species and generation of calibration curve
- Spiking of the biological solution with the appropriate DNA species
- DNA removal (for example, with membrane chromatography)
- Determination of DNA content before and after specific DNA removal steps
- At the conclusion of testing, a comprehensive report including all experimental detail will be provided
•Datasheet: DNA Qualification
