World Vaccine Congress Europe

High-Yield Monolith Purification to Produce Vaccines of Enhanced Purity

Speaker: Hana Jug

Abstract:

Newcastle disease virus (NDV) is a very infectious virus causing Newcastle disease, a serious condition among domesticated poultry and other avian species. Its high morbidity and mortality rates among infected birds give the disease significant economic importance. To compete against Newcastle disease infection, many commercially available vaccines based on live or inactivated virions are used. NDV is highly attenuated in humans and other primates because of strong host-range restriction.

Attenuated NDV has been evaluated as a vector for vaccines against SARSCoV-2, Ebola, H5N1 influenza, West Nile, and simian immunodeficiency viruses. Oncolytic NDV vectors also hold much promise for immunotherapies against various cancers. Whether for vaccines or viral-vector therapies, NDV particles must meet certain criteria for yield, purity, and concentration.

Convective Interaction Media monoliths are proven tools for the purification of large biomolecules, such as viruses, virus-like particles, and plasmids. We present purification method adjusted to the NDV virus vector.

A novel CCX.E10 suspension cell line was used for NDV production allowing drug manufacturers to bypass chicken-egg-related challenges, such as uncontrolled and inconsistent viral titers. It was demonstrated that the LaSota strain of NDV can be grown to 9 log10 focus forming units (FFU)/mL at low multiplicity of infection (MoI) within 24–48 hours. Downstream purification can be performed in one chromatography step, with high yield and purity. Based on CIMmultus SO3 (sulfonate) monolithic columns, the process yielded excellent recovery (75%) and impurity removal (99.0% depletion of proteins and 99.9% removal of DNA impurities) and enabled good manufacturing practice (GMP) scale-up to produce clinical-grade material in a day.  

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