Disclosed are a process and an automated facility for manufacturing a purified protein of interest. The protein of interest can be a recombinant or naturally occurring protein and/or a therapeutic or other medically useful protein. For example, the disclosed process and automated facility are useful for manufacturing a purified protein drug substance.

A sampling system includes a sensor (for example, a biosensor) that is provided in a sampling channel so as to be in contact with a sample and measures concentrations of predetermined components in the sample, an introduction path that introduces a cleaning liquid to an upstream side of the sensor of the sampling channel, and an air introduction path that is connected to the introduction path and is opened to the atmosphere. The air guided from the air introduction path flows into the sampling channel via the introduction path.

The present invention provides a system and a method for the production of cells and/or cell products. The system comprises at least one cell culture unit comprising at least one bioreactor for culturing cells, at least one technical control unit for controlling a cell growth parameters, said technical control unit is at least fluidly connected to the cell culture unit, and at least one air treatment unit for treating ambient air, said air treatment unit is fluidly connected to the cell culture unit. The system is characterized in that the system is autonomous and the bioreactor total volume is at most 1000L.

Disclosed are a process and an automated facility for manufacturing a purified protein of interest. The protein of interest can be a recombinant or naturally occurring protein and/or a therapeutic or other medically useful protein. For example, the disclosed process and automated facility are useful for manufacturing a purified protein drug substance.

Disclosed herein are cell processing systems, devices, and methods thereof. A system for cell processing may comprise a plurality of instruments each independently configured to perform one or more cell processing operations upon a cartridge, and a robot capable of moving the cartridge between each of the plurality of instruments.

Provided is a biological fluidic system that provides a high degree of sterilization by performing the biological processing in a closed system in which the fluid is contained in chambers that are isolated from the environment in a manner that does not permit ingress of contaminants.

A device enables easy preparation of a cell culture in a clean environment without introducing a large-scale facility for preparing a high-cleanliness space in the preparation of a cell culture. The device includes a sealed pouch-shaped container including: an internal space having a cleanliness level kept within a range from Class 1 to 9 specified in ISO 14644-1 by an air filter; an operation section that enables operation inside the container from outside the container; and a storage section that stores various materials required for preparing a cell culture.

This disclosure relates to equipment utilized to manufacture chemical agents, particularly biopharmaceuticals, using Disposable Containers (DCs).

In some aspects, the invention relates to automated cell culture incubators and their methods of use. In one aspect, the disclosure provides cell culture incubators having an airlock chamber, a storage chamber and/or an internal chamber. In some aspects, the disclosure provides methods for producing autologous mammalian cell cultures.

A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.