The invention relates to valve system for controlling a process fluid within a liquid processing system. The valve system comprises a valve arrangement, a pneumatic control system, and a connector unit. When the valve arrangement is connected to the connector unit, two or more valves are formed, such that the pneumatic control system controls an open/close or pressure control mode of the valves. A pump diaphragm system is disclosed, as well as a system for purifying a biological material that comprises the valve system or the pump diaphragm system. Also discloses are methods of using the valve system or the pump diaphragm system in a process for the purification of a biological material.

A method for promoting biological activity uses a filter system to increase cell production of a fed batch bioreactor. The filter system cycles bioreactor fluid through a hollow fiber tangential flow filter which separates metabolic wastes (as well as proteins) from cells produced in bioreactor and returned to fed batch bioreactor, improving cell production in the fed batch bioreactor. The filter system includes a disposable pump and filter, and a reusable control system. The pump is a low shear gamma stable pump gently cycling bioreactor fluid through the filter with minimal damage to the cells produced in the bioreactor. The pumphead and hollow fiber tangential flow filter are disposable. The pump motor is part of the control system and is reusable. The pumphead and filter are provided as an assembled and pre-sterilized unit allowing simple and quick attachment to the fed batch bioreactor, and simple and quick disposal.

Disclosed is a bioprocess system (1) comprising a flow path (3; 3a, 3) comprising: a plurality of inlets (7); at least one bio-processing device inlet connection (9a) and at least one bioprocessing device outlet connection (9b); a plurality of outlets (11); and flow path parts (5a′, 5b′, 5c′, 5d′, 5e′) of at least some active components (5a, 5b, 5c, 5d, 5e) comprised in the bioprocess system; and active parts (5a″, 5b″, 5c″, 5d″, 5e″) of said active components (5a, 5b, 5c, 5d, 5e). The flow path (3; 3a, 3b) of the bioprocess system is positioned centrally within the bioprocess system (1) and in a vertical orientation, whereby the active parts (5a″, 5b″, 5c″, 5d″, 5e″) are positioned around the flow path (3; 3a, 3b) being accessible from outside the bioprocess system (1) and each in connection with a corresponding flow path part (5a′, 5b′, 5c′, 5d′, 5e′) of an active component (5a, 5b, 5c, 5d, 5e).

Viral filters include a filter member featuring a first surface and a second surface and having a thickness extending between the first and second surfaces in a first direction, and a plurality of channels formed in the filter member, each of the channels having a channel axis, where during use, a solution carrying a viral load flows in a direction parallel to the first surface, and at least a portion of the viral load enters the membrane through the first surface and propagates in the first direction, and where for at least 50% of the channels in the filter member, the channel axis is oriented at an angle of between 5 degrees and 85 degrees relative to the first direction.

A multiple tangential flow filtration (TFF) apparatus includes a plurality of tangential flow filtration (TFF) systems, a support frame defining a plurality of stations for supporting individual (TFF) systems and a single controller for controlling the plurality of tangential flow filtration systems. Each of the systems include at least a product vessel, a tangential flow filtration (TFF) filter and a pump for circulating a flow of liquid between said product vessel and said filter.

The present invention provides, among other things, improved methods for purifying arylsulfatase A (ASA) protein produced recombinantly for enzyme replacement therapy. The present invention is, in part, based on the surprising discovery that recombinant ASA protein can be purified from unprocessed biological materials, such as, ASA-containing cell culture medium, using a process involving as few as four chromatography columns and only one step of post-chromatographic ultrafiltration/diafiltration.

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 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 bioprocessing system for protein manufacturing from human blood is provided that is compact, integrated and suited for on-demand production and delivery of therapeutic proteins to patients. The patient's own blood can be used as the source of cell extracts for the production of the therapeutic proteins.