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Publication Number

US-12306081-B2

Patent

Publication Date

2025-05-20

Expiration Date


Abstract

Described herein are apparatuses and methods for conditioning particles. In some embodiments, the apparatuses and methods are configured for first-in-first-out transit of particles through a chamber containing a conditioning fluid. In some embodiments, the apparatuses and methods of the present disclosure enable the manufacture of particle preparations containing large quantities of particles (e.g., cell-containing particles) with more consistent and improved properties relative to alternative manual processes.

Core Innovation

The invention relates to an apparatus and method for making conditioned particles by dispensing particles from a first orifice into a conditioning chamber. The conditioning chamber holds a first fluid to present a receiving surface and to receive the particles through an exit portal, and the conditioned particles are subsequently separated from a conditioning fluid in an exchange unit connected with the exit portal.

A selectable property in the apparatus enables separating particles from one another based on an attribute, including separating a particle of a first class from a particle of a second class after particle dispensation but prior to impinging on the receiving surface. In this class-based separation, a capture element is disposed between the orifice and the receiving surface and is configured to hinder the second class particle from impinging on the receiving surface, or a filter element is used for fractionation of conditioned particles in the exchange unit.

The apparatus and method further incorporate signal-based and sensing-based control to modulate process parameters or particle parameters. A component receives a signal and is responsive to the signal, including modulating a field through which the particle passes and sensing a distance from the orifice or dispensing port to the receiving surface to change to a desired distance.

The conditioning chamber is configured to provide a substantially linear path to support substantially similar residence time, and sterility is maintained for the orifice or dispensing port and the receiving surface. The housing optionally includes a port in connection with a source of displacement entity, and the method provides a plurality of exchange units connected in series.

Claims Coverage

The document contains two independent claims, with inventive features centered on a dispensing-to-conditioning-chamber architecture, class-based separation or fractionation, signal- and sensing-responsive modulation and control, substantially linear flow/residence time control, and sterility maintenance.

Dispensing into a conditioning chamber with a receiving surface and exit portal

The apparatus includes a particle dispensing unit with a first orifice dispensing particles into a conditioning chamber that holds a first fluid presenting a receiving surface and includes an exit portal configured to receive the particles and allow the received particle to flow through the conditioning chamber and through the exit portal.

Exchange unit separating conditioned particles from a conditioning fluid

The apparatus includes an exchange unit in fluid connection with the exit portal of the conditioning chamber in which the particles are separated from a conditioning fluid by introduction of a second fluid.

Class-based separation using a capture element between the orifice and receiving surface

The apparatus is configured to separate a particle of a first class from a particle of a second class after particle dispensation but prior to the dispensed particles impinging on the receiving surface of the first fluid, and comprises a capture element disposed between the orifice and the receiving surface and configured to hinder the second class particle from impinging on the receiving surface of the first fluid.

Fractionation using a filter element in the exchange unit

The apparatus comprises a filter element for fractionation of conditioned particles in the exchange unit.

Signal-responsive modulation of process or particle parameter

A component of the apparatus is configured to receive a signal and responsive to the signal modulate the process parameter or the particle parameter, including responsive to the signal a field through which the particle passes is modulated.

Distance sensing and changing to a desired orifice-to-receiving-surface distance

The apparatus is configured such that responsive to the signal it senses a distance from the orifice to the receiving surface of the first fluid in the conditioning chamber and changes to a desired distance.

Housing with sterility-maintaining port connected to a source of displacement entity

The first orifice and the receiving surface are disposed within a housing wherein the housing comprises a port in connection with a source of displacement entity, and the apparatus is configured such that the orifice and the receiving surface of the first fluid are disposed within a housing that can maintain sterility.

Substantially linear path to provide similar residence time

A portion, or all, of the conditioning chamber beneath the receiving surface is configured to provide a substantially linear path for conditioned particles transiting the conditioning chamber.

Method dispensing by pumping particle-forming fluids to a dispensing port and moving toward a receiving surface

The method pumps at least two particle forming fluids to a dispensing port and causes each particle to move from the dispensing port towards a receiving surface of a first conditioning fluid in a conditioning chamber.

Class-based separation and/or filtering within the conditioning chamber

The method includes at least one of separating particles from one another based on a property of the particles, including separating a particle of a first class from a particle of a second class after particle dispensation but prior to the dispensed particles impinging on the receiving surface, and comprising a capture element disposed between the dispensing port and the receiving surface and configured to hinder a second class particle from impinging on the receiving surface of the first conditioning fluid; or filtering particles received by the conditioning fluid.

Signal-responsive modulation and sensing, including modulating a field and sensing distance

The method receives a signal and is responsive to the signal modulating a process parameter or a particle parameter, including responsive to the signal modulating a field through which the particles pass and sensing a distance from the dispensing port to the receiving surface of the conditioning fluid in the conditioning chamber.

Distance modulation by modulating a volume of a displacement entity

The method modulates a distance between the receiving surface of the first conditioning fluid and the dispensing port by modulating a volume of a displacement entity in the conditioning chamber.

Substantially linear path providing similar residence time

The method provides a substantially linear path for conditioned particles transiting the conditioning chamber such that a residence time of conditioned particles in the conditioning chamber are substantially similar.

Conditioned particle separation in an exchange unit and optional series of exchange units

The method separates conditioned particles from the first conditioning fluid in an exchange unit and provides a plurality of exchange units connected in series.

Maintaining sterility of the dispensing port and receiving surface

The method maintains sterility of the dispensing port and the receiving surface of the conditioning fluid.

Across the independent claims, the core coverage is an automated dispensing into a conditioning chamber with a receiving surface and exit portal, followed by an exchange unit for separating conditioned particles from a conditioning fluid, combined with selectable separation or fractionation via a capture element or filter element. Both independent claims further require signal-responsive modulation, sensing and distance control, a substantially linear path for substantially similar residence time, and maintaining sterility for the dispensing orifice-related interfaces.

Stated Advantages

Enables separating particles from one another based on an attribute of the particles, including class-based separation and/or fractionation of conditioned particles.

Provides controlled residence time by providing a substantially linear path such that residence time of conditioned particles are substantially similar.

Maintains sterility of the dispensing port and the receiving surface of the conditioning fluid.

Documented Applications

No documented applications found

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