Methods for evaluating viral clearance from a biopharmaceutical solution employing mock viral particles
View Patent ↗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.
1. 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.
2. The method of claim 1 , wherein said biologic of interest is produced by a process, wherein said process is either a cell culture process or a fermentation process, and wherein said process utilizes human cells, animal cells, plant cells, insect cells, hybridomas cells, yeast cell, or bacterial cells.
3. The method according to claim 1 , wherein biologic of interest is purified through step (b).
4. The method of claim 1 , wherein the purification technique is a chromatography, filtration, ultrafiltration, centrifugation, or viral inactivation technique.
5. The method according to claim 1 , wherein step (a) the quantity of MVP in said solution is greater than the quantity of MVP in solution after step (b).
6. The method of claim 1 , wherein the MVP comprises a viral capsid and an envelope protein.
7. The method of claim 6 , wherein said viral capsid or envelope protein is produced in a bacteria, yeast, plant, insect cell, animal or human cell.
8. The method of claim 6 , wherein viral capsid or envelope protein is derived from a Parvoviridae or Retroviridae source.
9. The method of claim 1 , wherein said MVP contains in vitro nucleic acid.
10. The method of claim 1 , wherein evaluating viral clearance from the solution comprises the use of a quantification technique for determining the amount of MVP in a solution selected from ELISA, PCR, nanoimaging, fluorescence, enzymatic, microscopy, spectrophotometry, transmission electron microscopy (TEM), or western blot analyses techniques.
11. The method of claim 10 , wherein the quantification technique uses an antibody capable of binding to a capsid protein epitope or an envelope protein epitope present on the surface of the MVP.
12. The method of claim 10 , wherein the quantification technique uses a primer capable of binding to an in vitro nucleic acid sequence contained within the MVP.
13. The method of claim 1 wherein said method further comprises:
a) adding a second species of MVP to the solution;
b) processing the solution through a purification technique; and
c) quantifying the amount of the second species of MVP removed from the solution.
14. The method of claim 13 , wherein the first species of MVP and the second species of MVP are added to the solution at the same time.
15. The method of claim 13 , wherein two or more additional species of MVP are added to the solution.
16. The method of claim 13 , wherein the first species of MVP and the second species of MVP are added to the solution sequentially.