Trizell Limited

Ferring Ventures Ltd

Minna Hassinen

Nigel Parker

Robert Shaw

Jenni Mykkanen

Hanna P Lesch

Sara Paulo

Seppo Yla-Herttuala

Minna Kristiina Karhinen

Eevi Lipponen

Joonas Malinen

Hanna Peltonen

A temperature-responsive virus storage system that allows virus to be stored, such as a non-frozen liquid, and maintain infectivity is described.

Temperature-responsive virus storage system

A process for assaying viral vector manufactured by large-scale viral vector manufacturing processes to assure the resulting vector has acceptable purity and potency. The process entails three different types of assays, each one of which is optionally useful on a stand-alone basis, and which together provide the first system able to assure the quality of viral vector produced by large-scale vector manufacturing processes.

Viral vector assay and vector

Certain viral gene therapy vectors are by design unable to replicate in a patient. Nonetheless, during manufacture of viral gene therapy vector, undesirable replication-competent virus ('RCV') may form due to random mutation or other events. Viral gene therapy vector manufacturers thus assay for the presence of contaminating RCV. Regulatory agencies require this to be done by assaying for serial infection, i.e., transducing target cells with the viral vector, and then lysing the transduced cells, and then mixing the lysate with live assay cells, and then microscopically observing the assay cells to visually determine whether they have been infected with virus. We have tested various alternative approaches, and surprisingly found that digital PCR is not only faster than the prior art approach, but is also over an order of magnitude more sensitive, able to detect, for example, in 3×10assay cells, as few as seven (7) replication competent adenoviruses (“RCA”).

Gene therapy vector contamination assay

Combining viral vector with surfactant preserves vector infectivity, and surfactant provided an unexpected benefit by protecting viral vector from damage due to transient elevated temperature.

Viral vector stabilization

Growing community of inventors

Kuopio, Finland

Minna Hassinen