Table II

Viruses Intended for Inclusion in Virus Clearance Demonstration for Vaccine Candidate Produced in Insect Cell/Baculovirus System

VirusVirus TypeSizeRationale for Inclusion
BaculovirusEnveloped250–300 nmHigh titer (∼109 vp/mL) in cell culture harvest
XMuLVEnveloped80–130 nmModel retrovirus; reverse transcriptase activity is present in some insect cell lines
PPVNon-enveloped18–26 nmNon-enveloped virus. PPV was selected over MMV for this vaccine candidate because the process streams presented significant toxicity issues for the indicator cells used for the MMV infectivity assay