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AssigneeBaxter Aktiengesellschaft
InventorsKlaus Zimmermann, Dirk Volkel, Peter Turecek, Hans-Peter Schwarz, Manfred Rieger
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Methods are disclosed that permit pathogenic agent detection and differentiation between infectious and non-infectious forms. Specifically, the present invention provides for pathogenic agent detection using nucleic acid amplification and detection techniques. Moreover, these nucleic acid amplification and detection techniques permit infectious pathogens to be distinguished from non-infectious forms. Also disclosed is a method used to detect and distinguishes between infectious and non-infectious pathogens in biological products and pharmaceutical preparations.
A method for detection, differentiation and quantification of free and encapsulated target nucleic acids in a sample comprising:
A method for determining and controlling virus inactivation rates of a virus inactivation processes comprising:
An infectious pathogen inactivation process validation method comprising:
The method of claim 19 further comprising subtracting said digested inactivated spiked sample's infectious agent nucleic acid content from said inactivated spiked sample's infectious agent nucleic acid content.
Dependencies are inferred from the claim text.