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 parent's own blood can be used as the source of cell extracts for the production of the therapeutic proteins.

Automated blood processing systems and methods including a durable hardware component, a single use fluid flow circuit, and a controller configured to determine and add a custom amount of additive solution. More particularly, systems and methods for adding a custom amount of a red blood cell (RBC) additive solution to obtain a target RBC product with a target hematocrit.

Methods and systems are provided automatically removing air from a collection container for a blood product. The system comprises a disposable flow circuit including a tubing in fluid communication with the collection container and a durable hardware component. A programmable controller operates the pump in a first/forward direction to flow the target product into the collection container; determines that substantially all the target product has been pumped into the collection container; and operates the pump in the first/forward direction to pump a chase volume of air into the collection container along with any target product remaining in the tubing. In one embodiment, after the chase volume of air is pumped into the collection container, the controller operates the pump in a second/reverse direction for removing air from the collection container, and stops operation of the pump when the amount of air removed from the collection container is substantially equal to the residual volume of air.

A method of manufacturing a tube sheet by forming a plurality of separate thin tube sheet segments; forming multiple holes in each sheet in a predetermined pattern, each hole for accommodating a tube sheet filter tube; aligning all of the plurality of tube sheet segments so that the hole pattern of each sheet aligns with the hole pattern in all other sheets of the plurality of tube sheet segments; and securing all of the tube sheet segments together to form a unitary tube sheet. A tube sheet construction that includes a plurality of separate thin tube sheet segments, multiple holes being provided in each sheet in a predetermined pattern, each hole for accommodating a tube sheet filter tube, all of the tube sheet segments being aligning so that the hole pattern of each sheet aligns, and fasteners for securing all of the tube sheet segments together. A media layer is provided between adjacent sheet segments.

An independent blood filter device depends on flow geometry to deliver blood serum or plasma free of detrimental levels of hemoglobin. It depends critically on an upstream flow rate or pressure differential limiting control element or device that limits the rate of change of pressure differential across the filter element. Pre-evacuated versions can be used to simultaneously draw blood from a living being and provide pressure differential across the filter element between an evacuated collector and a supply end open to atmosphere. A unit pressurized by hand motion employs the external shape of a partially filled blood collection tube as a piston to produce pressure in advance of the control element or device to create the pressure differential across the filter element to a collector vented to atmosphere. The control element or device is disclosed in numerous forms, including specially sized flow constrictions and compliant arrangements.

Embodiments provide methods and apparatus for fabricating blood products, such as platelet-rich plasma, containing elevated concentrations of growth factors such as platelet derived growth factor. The platelet-rich plasma can be autologous, and the concentration of growth factors (e.g., platelet derived growth factor) is elevated relative to other samples isolated from the same subject. The platelet-rich plasma can be used to promote tissue regeneration, including wound healing, joint repair, hair growth, and the like. The compositions can be combined with stem cells and used to treat disorders otherwise treated with stem cells. The growth factors present in the samples can direct the differentiation of the stem cells.

Provided are methods of continuous counterflow centrifugation for the manufacturing of cell compositions, including for the production of T cell therapies including cells that express recombinant receptors such as chimeric antigen receptors (CARs).

A method of manufacturing a tube sheet by forming a plurality of separate thin tube sheet segments; forming multiple holes in each sheet in a predetermined pattern, each hole for accommodating a tube sheet filter tube; aligning all of the plurality of tube sheet segments so that the hole pattern of each sheet aligns with the hole pattern in all other sheets of the plurality of tube sheet segments; and securing all of the tube sheet segments together to form a unitary tube sheet. A tube sheet construction that includes a plurality of separate thin tube sheet segments, multiple holes being provided in each sheet in a predetermined pattern, each hole for accommodating a tube sheet filter tube, all of the tube sheet segments being aligning so that the hole pattern of each sheet aligns, and fasteners for securing all of the tube sheet segments together. A media layer is provided between adjacent sheet segments.

Delivering a blood processing solution to blood in a blood bag includes coupling a first tube to a vented spike at one end and to a Y-shaped tube connector at a second end. An in-line microbiotic barrier filter is coupled to the first tube between its ends. A second tube is coupled to a transfer bag at one end and to the Y-shaped tube connector at its other end. A third tube is coupled to the output of the Y-shaped tube connector and sealed at its distal end. The blood bag includes a fourth tube that is sealed at a distal end. The third tube is welded to the fourth tube using a sterile tubing welder, wherein a functionally-closed, sterile flow path through which the blood processing solution can flow into the blood bag is maintained.

The present disclosure relates to methods and devices for the separation of blood components including separation by rapid sedimentation, including in an automated fashion.