Abstract
Continuous cell lines (used in the manufacture of monoclonal antibodies and other therapeutic proteins) may harbour retroviral particles; nevertheless, they are deemed acceptable if the production system is validated for clearance of these contaminants. As part of a campaign to evaluate and validate appropriate virus removal methodologies for monoclonal immunoglobulin G (IgG) products, studies were undertaken with a hydrophilic polyvinylidene fluoride (PVDF) microporous membrane—the Ultipor® VF grade DV50 virus removal membrane. Testing conducted with murine leukaemia virus, a specific model virus used in viral validation studies to document removal of retroviruses, demonstrated a greater that 7 log clearance by the Ulipor® VR grade DV50 membrane. Filterability testing established the feasability of positioning the filter at either of two different stages during manufacture. The results presented in this study demonstrate that membrane filtration through the Ultipor VF grade DV50 virus removal filter can constitute part of the purification regimen to effect removal of endogenous retrovirus-like contaminants from monoclonal lgG products.
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