Ge Healthcare Bio-sciences Corp.

Global Life Sciences Solutions USA LLC

Joseph Makowiecki

Parrish M Galliher

John J Vicalvi

Joseph D Crowell

Edward G Hayman

John J Vicalvi, Jr

Michael Edward Fisher

Scott A Mangiacotti

Joseph J Arduino

Disclosed herein is provided a virus purification and formulation process for purifying a flavivirus represented by one of a Yellow Fever Virus, Japanese Encephalitis virus, Dengue virus, and West Nile virus. The highly purified flavivirus virus product is characterized as having a low level of sucrose without significant virus loss such as that which is typically encountered by prior art virus purification processes. The disclosed process captures and purifies the virus, separating it from the host cell proteins and DNA, and leaving the host cell proteins and DNA behind. The process also can be used to inactivate and/or concentrate the virus sufficiently for use in formulations.

Virus purification and formulation process

Methods and systems for chromatography are disclosed that employ a flexible container configured to fit within a support structure and adapted to receive a filtration or absorptive medium. The flexible container can include at least one inlet, at least one outlet, and a separation barrier peripherally sealed within the container to separate the container into a resin containing portion and a drainage portion. The barrier can be configured to exclude the resin material from the drainage portion while allowing fluids to pass therethrough. The disposable chromatography system can further include one or more agitators disposed within the flexible container and adjustably configured to be raised or lowered in the flexible container. When the agitator is in the raised position, the resin packing material can operate in a settled, packed-bed configuration. Alternatively, the agitator in the lowered position permits the chromatography resin packing material to operate in a mixed, slurry configuration.

Single use slurrying and chromatography systems

Methods and systems for chromatography are disclosed that employ a flexible container configured to fit within a support structure and adapted to receive a filtration or absorptive medium, such as a chromatography resin. The flexible container can include at least one inlet, at least one outlet, and a separation barrier peripherally sealed within the container to separate the container into a resin containing portion and a drainage portion. The barrier can be configured to exclude the resin material from the drainage portion during use while allowing fluids to pass therethrough. The disposable chromatography system can further include one or more agitators disposed within the flexible container and adjustably configured to be raised or lowered in the flexible container. When the agitator is in the raised position, the resin packing material can operate in a settled, packed-bed configuration. Alternatively, the agitator in the lowered position permits the chromatography resin packing material to operate in a mixed, slurry configuration.

Disclosed herein is provided a virus purification and formulation process for purifying a flavivirus represented by one of a a Yellow Fever Virus, Japanese Encephalitis virus, Dengue virus, and West Nile virus. The highly purified flavivirus virus product is characterized as having a low level of sucrose without significant virus loss such as that which is typically encountered by prior art virus purification processes. The disclosed process captures and purifies the virus, separating it from the host cell proteins and DNA, and leaving the host cell proteins and DNA behind. The process also can be used to inactivate and/or concentrate the virus sufficiently for use in formulations.

A disposable filtration system can include a disposable filter housing having an ultrafiltration filter contained therein. The disposable filtration system can further include a feed inlet and retentate outlet in fluid communication on one side of the filter and a permeate conduit on the other side of the filter for withdrawing permeate that passes through the filter. The system can include at least one disposable pressure control valve in fluid communication with either the retentate outlet or the permeate conduit and configured to regulate the pressure within the housing.

Growing community of inventors

Oxford, MA, United States of America

Joseph Makowiecki