Marcus Hartmann
Cilian AG, Germany
Title: CiFlu®: Development of a novel subunit influenza vaccine candidate based on the ciliate performance expression system
Biography
Biography: Marcus Hartmann
Abstract
The critical annual manufacturing process for seasonal influenza vaccine based on embryonated chicken eggs, involves numerous steps and takes on average 6 to 8 months to complete. This often means that vaccine is only available late into the flu season. The timely availability of an effective influenza vaccine, at or before the flu season starts, is even more acute for vulnerable highest risk groups such as persons 65 years of age and older. The lack of timely availability of seasonal/pandemic vaccine has raised significant questions about the utility of the current, antiquated, cumbersome, expensive and unsafe manufacturing platform involving chicken eggs. Safety concerns about cell culture based virus proliferation processes called also alternative flu vaccines production processes into question. Now new recombinant antigen manufacturing platforms were postulated to reduce production time and costs. Cilian’s flu vaccine CiFlu® is a cost-effective subunit vaccine based on the heterologous expression of recombinant Influenza hemagglutinin (rHA) in the ciliate Tetrahymena. Utilizing its CIPEX-System as such a manufacturing platform, Cilian has successfully demonstrated repeated expression of rHA at high yield: four subunit vaccines has been expressed and shown to be functionally active. Mice were first immunized with the monovalent rHA. HA antibodies were harvested and its ability to inhibit the respective influenza strain was tested. The results demonstrated comparable or better efficacy (in vivo inhibitory immunogenicity) to monovalent vaccine from chicken eggs. Cilian meanwhile received a positive scientific advice from the German Paul Ehrlich Institute for CiFlu® and is developing a comprehensive clinical plan.
