Provided herein are isolation processes and the associated hardware to allow fluid streams to be isolated from a sterilized system (e.g., a sterile process vessel) that contains a sterile process. The isolation processes described herein allow for continuous removal of fluid streams (e.g., waste streams, liquid containing recombinant therapeutic proteins) from a sterilized system (e.g., a biological manufacturing system), which provides for less manual manipulation of the sterilized system and a decreased risk of contaminating the sterilized system.

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 customizable facility for manufacturing at least one product has at least one modular unit in communication with at least one central unit configured to provide utilities to the at least one modular unit. In some embodiments, the central unit(s) and modular unit(s) are positioned at least partially within a shell. Each modular unit can be a fermentation unit, a pre-viral unit, a post-viral unit, a utility space, a warehouse, a media buffer facility, an office, a personnel unit, or another unit. The modular units can be arranged to maximize a number of modular units within the shell while minimizing a footprint of the shell. A method of assembling a facility for manufacturing at least one product includes providing at least one central unit and providing at least one modular unit in communication with the central unit(s) such that utilities are provided by the central unit(s) to the modular unit(s).

The invention discloses a bioreactor apparatus (1;101;201;301) for cultivation of cells comprising: a) a disposable bioreactor vessel (2) with one or more walls (3,4,5) defining an inner volume (6), at least one port (10) in a wall, wherein the disposable bioreactor vessel is positioned in a rigid support structure (8;108); and b) a heater (9;109;209;309), capable of heating an amount of culture medium to a target temperature in the range of 55-95° C., while the amount of culture medium is being confined in or conveyed to the inner volume.

The disclosure features methods that include obtaining a vibrational spectrum of a solution in a biological manufacturing system, analyzing the vibrational spectrum using a first chemometrics model to determine a value of a first quality attribute associated with the solution, analyzing the vibrational spectrum using a second chemometrics model to determine a value of a second quality attribute associated with the solution, and adjusting at least one parameter of a purification unit of the biological manufacturing system based on at least one of the values of the first and second quality attributes.

Provided is a cell treatment apparatus that includes: an isolator; a disposal box that includes a storage part; and a decontamination unit, wherein the disposal box includes: a first opening and closing device that is configured to allow the isolator and the storage part to be communicated with each other at the time of disposal of the waste product and allow them to be shut off from each other after the putting-in of the waste product and before the disposal of the same; and a second opening and closing device that is configured to allow the storage part and the outside to be communicated with each other at the time of disposal of the waste product, which has been put into the storage part, and allow them to be shut off from each other after the disposal of the waste product.

The present invention relates to an automated integrated continuous bioprocess system and bioprocess that are capable of continuously producing therapeutic protein in an uninterrupted manner and scalable from laboratory to manufacturing scale. The present invention provides an automated integrated continuous bioprocess system and bioprocess for producing therapeutic protein, in which the system and process is controlled with one or more control system selected from supervisory control and data acquisition (SCADA) control system (110), proportional integral derivative (PID), programmable logic circuit (PLC), industrial PC (IPC), distributed control system (DCS), message relaying system and automated UPLC/HPLC sampling for online testing to run the system and process and in an uninterrupted manner and continuously produce therapeutic protein.

The present invention relates to a method for decomposing peracetic acid and a method for culturing microorganisms using the decomposition method. The cultivation of microorganisms using the method of the present invention allows an effective removal of the peracetic acid used in a culture medium for sterilization.

A perfusion bioreactor system has an inner chamber and scaffold with matching porosities to equalize fluid flow through a bioreactor. The scaffold can be fabricated using additive manufacturing or other fabrication techniques to match the geometrical shape of a defect, such as a facial bone anomaly. The inner chamber is fabricated in a similar manner and has an inner cavity matching the shape of the scaffold to create a unified structure when assembled together with the scaffold. By matching the shapes of the scaffold and inner chamber, free space is eliminated within the interior volume of the bioreactor. Stem cells can be flowed through the bioreactor and attached to the scaffold, which are then cultured to grow a tissue graft.

Transfer mechanism/device (40) transferring one or more objects (O) through a transfer port (R), having a supporting base (41), a shuttle (42) with a mount (43) for a holder (47) for the one or more objects (O) or with a holder (47) and a container (44) accommodating the base (41) and the shuttle (42) and accommodating the objects (O), and having at least one opening (45) at an end portion in an axial direction (X) of the container (44).