Methods for evaluating viral clearance from a process solution employing mock viral particles
AssigneeMockV Solutions, Inc.
InventorsDavid Cetlin, Arun Dhar
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Abstract
The present invention relates to a method of quantifying the amount of Mock Virus Particles (MVP) removed from a solution as a result of processing that solution through a purification technique. This method involves the steps of adding MVP to a solution, processing the solution through a purification technique, quantifying the amount of MVP removed from the solution. The present invention also relates to a kit that can be used in conjunction with the method. This kit will comprise at least one stock solution of MVP and at least one quantification solution.
Claims15
A method of evaluating viral clearance from a process solution wherein the method comprises:
- a) obtaining a process solution and a process collection, wherein
- i) the process solution comprises:
- (1) a biologic of interest selected from an antibody, non-antibody protein, vaccine, nucleic acid product, blood or plasma derivative;
- and
- (2) a Mock Viral Particle (MVP), wherein the MVP is a non-infectious, non-replicating assembled unit comprising a viral capsid or envelope protein and wherein said MVP physiochemically resembles the virus from which the protein was derived;
- and wherein
- ii) the process solution had been processed through a purification technique to generate the process collection;
- and
- b) quantifying the amount of MVP removed from the process solution by determining and comparing the quantity of MVP in the process solution to the quantity of MVP in the process collection.
Dependencies are inferred from the claim text.