Description:
Cell-culture-based technology for vaccine production is robust,
reliable, and could become a practical alternative for the pharmaceutical
industry. Once the virus is propagated and harvested, the downstream processing
parameters for purification, filling, and packaging of the vaccine are similar
to current pharmaceutical methodologies and egg-based methodologies. However,
there are no lead times involved because typical cell-culture processes use cell
lines. Once a cell line is infected with the seed virus in a fermenter, the
process can begin. The critical aspect is the availability of the seed virus.
The substrates or media for cell-line propagation are also not susceptible to
virulent virus strains like embryonated chicken eggs.
The
cell-culture vaccine process is suitable for large-scale manufacturing, and the
process parameters can be ramped up and run routinely and cost-effectively. The
typical cell-culture production process can be run in batch sizes of practical
scale, sufficient to provide vaccine quantities for interpandemic periods and
pandemics. However, to date, no vaccines have been licensed using this
technology in the United States.
Description
Michigan
State University’s invention is an immortalized chick fibroblast cell line in
bovine-free substrate that is non-tumorigenic and exhibits more efficient and
higher yield production than chick embryos.
Benefits
·
Safe cell line:
Testing was completed to prove the cell line is non-tumorigenic, unlike
Madin-Darby canine kidney (MDCK) and Per C6 cells, two of the competing cell
lines for vaccine production.
·
Efficient downstream process:
This immortalized cell line does not require additional porcine or synthetic
trypsin to cleave off the virus particle.
·
Higher yield system: The
invention supports replication of most types of influenza and produces more
influenza virus per unit than MDCK and Per C6 cells.
·
Serum- and animal product-free
substrate: The FDA requires that all cell line based systems are
free of bovine plasma or proteins, so there is no safety concern for prions.
·
Ability to grow other viruses:
This cell line has effectively produced reovirus, herpesvirus, influenza, and
adenovirus.
Applications
The
technology can be used by pharmaceutical and biotechnology companies to develop
vaccines for medical and veterinary use.
IP Protection
Status
Patent
pending
