Methods for evaluating viral clearance from a biopharmaceutical 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.
Claims16
A method of evaluating viral clearance from a biopharmaceutical solution wherein the method comprises:
- a) adding a Mock Viral Particle (MVP) to a biopharmaceutical solution, wherein the solution comprises a biologic of interest selected from an antibody, non-antibody protein, vaccine, nucleic acid product, blood or plasma derivative, and 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;
- b) processing the solution through a purification technique;
- and
- c) quantifying the amount of MVP removed from the solution.
Dependencies are inferred from the claim text.