Virus purification

摘要

A process for producing a retroviral or lentiviral vector formulation comprising a filter-sterilization step wherein the filter-sterilization step is not the final step in the purification process.

主权项

1. A process for producing a retroviral vector formulation comprising a purification step, a filter-sterilisation step and a concentration step, wherein the filter-sterilisation step is the penultimate step in the production process, wherein the filter-sterilisation step is performed using a sterilising filter with a maximum pore size of 0.2 μm, wherein the concentration step is performed in aseptic conditions, wherein the concentration step is the final step in the process, and wherein concentration of the retroviral vector formulation is performed using an ultrafiltration step; wherein the retroviral vector formulation is suitable for ex vivo administration or for administration to a patient.