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.

The concepts described herein are directed to implementations of production facilities that can produce molecules used to treat biological conditions, such as biotherapeutics. The biotherapeutics can include various molecules, such as proteins, enzymes, and antibodies. The production facilities can include a number of separate modular cleanrooms that comprise particular pieces of equipment to perform one or more aspects of the processes used to manufacture biotherapeutics. The modular cleanrooms are arranged such that material that is produced by the equipment of one modular cleanroom can be transferred to another modular cleanroom for additional processing. Additionally, systems and processes are described to generate models using machine learning techniques, where the models can be used to predict productivity and/or efficiency metrics for production lines of biotherapeutics. Further, models can be generated to control the operation of pieces of equipment included in the production lines.

A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.

An atomization device according to the present invention is provided with: a main body part which has a container space that contains a hydrogen peroxide solution; and a diaphragm which is provided with through holes where the hydrogen peroxide solution contained in the container space passes, and which atomizes the hydrogen peroxide solution passing through the through holes.

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.

A mobile processing laboratory (MPL) is provided, configured for facilitating performing therewithin a cell therapy process. The MPL comprises a portable enclosure; one or more pieces of laboratory equipment for carrying out the cell therapy process and being housed within the enclosure; a plurality of sensors, each configured to measure information regarding the environment, cellular material of the process, and/or one of the pieces of laboratory equipment; and a computer system configured for management of the cell therapy process. The computer system is configured to facilitate collecting data from the sensors, and to optimize one or more activities associated with performance of the cell therapy process based on data collected from one or more other MPLs configured for performing therewithin substantially the same cell therapy process.

Biomanufacturing hygiene control in batch and fed-batch bioreactors is provided using a bioreactor employing a chlorite/Cld system, wherein the bioreactor comprises an engineered cultured cell expressing a recombinant cytoplasmic chlorite dismutase (cCld) sufficient to increase chlorite resistance of the cell, and chlorite sufficient to substantially inhibit growth of one or more contaminating microorganisms in the bioreactor yet not substantially inhibit growth of the cell.

Embodiments of the present invention provide an automatic micro algae culturing device and system for self-cleaning, continual automatic algae culturing and irradiant optimizing. The culturing device includes a photosynthesis tubular reactor for micro algae culturing, with transparent cleaning particles to scrape off any unwanted particles or components such as including and not limited to formation of biofilm. The tubular reactor has multiple double-walled glasses. Inner walls of the tubes in the tubular reactor may be coated with superhydrophobic coating to avoid bio film formation, or sticking of any hydro dirt or dust particles. Because the cleaning particles are transparent, they wont block any sunlight for photosynthesis in the tubular reactor.

The present invention discloses an automated device for tissue and organ engineering. The device comprises a main chamber for performing decellularization, tissue sterilization, and recellularization and a set of solution and medium chambers, which provide solutions and medium for the decellularization and recellularization processes, respectively, in a continuous closed circuit. The device further comprises a sterilizing system for self-sterilization of the automated device. The device further comprises a user interface to input steps of protocols for tissue or organ engineering. The device further comprises a controller configured to control valves and pumps, which control and direct the flow of solutions and medium based on the steps of protocols, thereby automating the processes of decellularization, tissue sterilization, recellularization and self-sterilization. All parts of the device are installed in one single body in a fully integrated manner, in one example, which makes the device ready to use. The device minimizes the user intervention and enhances sterility, reproducibility, and efficiency.

A functional element for a beta container of a transfer system, wherein the functional element is arrangeable on and/or in a beta port opening of a beta port, and the functional element comprises a functional element opening that is smaller than the beta port opening. There is also disclosed a functional element for a beta container of a transfer system, wherein the functional element is arrangeable on and/or in a beta port opening of a beta port, the functional element comprises one or more nutrient medium carrier holders, and each nutrient medium carrier holder is configured to hold a nutrient medium carrier. Furthermore, there is also disclosed a beta container for a transfer system, a transfer system, and a barrier system, such as an isolator system.