EP-4737911-A1 - APPARATUS AND METHOD FOR TAKING OUT COMPOSITE FROM FLOW PATH

EP4737911A1EP 4737911 A1EP4737911 A1EP 4737911A1EP-4737911-A1

Abstract

The present disclosure provides an apparatus and a method for taking out a particular fraction from a flow path. More particularly, in one aspect, the present disclosure provides a method for taking out a particular fraction from a flow path. The method includes: a step for flowing a component through the flow path; a step for taking out a fraction from the collection part on the flow path by means of a dispenser provided with a valve; and a step for distributing the fraction to the receiving part. In one embodiment, the collection part is positioned in a middle portion of the flow path (a portion that is neither an inflow port nor an outflow port of the flow path).

Inventors

MATSUZAKI, TAKASHI
FUJIKI, Daichi

Assignees

The University of Osaka
Shionogi Pharma Co., Ltd.

Dates

Publication Date: 20260506
Application Date: 20240628

Claims (18)

A method for removing a specific fraction from a flow channel, the method comprising: allowing a component to flow through the flow channel; removing a fraction from a collection portion on the flow channel by means of a dispenser comprising a valve; and dispensing the fraction to a receiving portion.
The method according to claim 1, wherein a time taken for removing one fraction is 1 second or less.
The method according to claim 1 or 2, wherein the dispenser is moved at a velocity of 200 mm/sec or more in the dispensing the fraction to the receiving portion.
The method according to any one of claims 1 to 3, wherein the valve is a slide solenoid valve.
The method according to any one of claims 1 to 4, wherein the collection portion is positioned in a middle of the flow channel.
The method according to any one of claims 1 to 5, wherein a time taken for dispensing a fluid in one fraction to one receiving portion is 1 second or less.
The method according to any one of claims 1 to 6, wherein the dispensing comprises dispensing a plurality of the fractions to the receiving portion comprising a plurality of compartments.
The method according to any one of claims 1 to 7, wherein a time when the fraction is removed from the collection portion is controlled based on a time and/or a flow velocity at which the component is injected into the flow channel.
The method according to any one of claims 1 to 8, further comprising detecting a status of the component upstream of the collecting portion on the flow channel.
The method according to any one of claims 1 to 9, wherein the method comprising testing the fraction having been dispensed.
A method for producing a formulation comprising: a first component; and a second component, the method comprising: preparing a series of flow channels comprising a first flow channel through which a first fluid flows at a first flow velocity, a second flow channel through which a second fluid flows at a second flow velocity, and a third flow channel through which a third fluid flows at a third flow velocity, the third flow channel being formed by combining the first flow channel and the second flow channel at a combination portion; injecting a sample comprising the first component into the first flow channel at a first time; injecting a sample comprising the second component into the second flow channel at a second time; and removing a fraction comprising a composite comprising the first component and the second component from the third flow channel using the method according to claim 1; the first time and the second time being set so that the first component and the second component reach the combination portion at a time when the first component and the second component are mixed.
An apparatus for removing a specific fraction from a flow channel, the apparatus comprising: a flow channel; a dispenser attached to a collection portion on the flow channel; and a receiving portion that receives a fraction having been removed from the dispenser; the dispenser comprising a valve.
The apparatus according to claim 12, wherein the valve is a slide solenoid valve.
The apparatus according to claim 12 or 13, wherein the collection portion is positioned in a middle of the flow channel.
The apparatus according to any one of claims 12 to 14, wherein the receiving portion comprises a plurality of compartments that receive a plurality of fractions.
The apparatus according to any one of claims 12 to 15, further comprising an injection portion from which a sample is injected into the flow channel; and a control portion, the control portion controlling an operation time between the injection portion and the dispenser.
An apparatus for injecting a plurality of samples into a plurality of flow channels at a time when a first component and a second component are mixed, the apparatus comprising: a first flow channel through which a first fluid flows; a first injection portion from which a sample comprising the first component is injected into the first flow channel; a second flow channel through which a second fluid flows; a second injection portion from which a sample comprising the second component is injected into the second flow channel; a combination portion in which the first flow channel and the second flow channel combine with each other; a third flow channel through which a third fluid flows and which extends from the combination portion; and the dispenser and the receiving portion in the apparatus according to any one of claims 12 to 16; and a control portion, the control portion being configured to control a time when the first injection portion injects the first component into the first flow channel and a time when the second injection portion injects the second component into the second flow channel.
An apparatus for producing a formulation comprising: a first component; and a second component, the apparatus comprising: a first flow channel through which a first fluid flows; a first injection portion from which a sample comprising the first component is injected into the first flow channel; a second flow channel through which a second fluid flows; a second injection portion from which a sample comprising the second component is injected into the second flow channel; a combination portion in which the first flow channel and the second flow channel combine with each other; a third flow channel through which a third fluid flows and which extends from the combination portion; and the dispenser and the receiving portion in the apparatus according to any one of claims 12 to 16; and a control portion, the control portion controlling the dispenser and the receiving portion to remove a fraction comprising a composite comprising the first component and the second component from the third flow channel using the method according to any one of claims 12 to 16; and the control portion being configured to control a time when the first injection portion injects the first component into the first flow channel and a time when the second injection portion injects the second component into the second flow channel.

Description

[Technical Field] The present disclosure relates to an apparatus and a method for removing a composite from a flow channel. More specifically, the present disclosure relates to a technique for removing a composite from a flow channel by removing a fraction by means of a dispenser including a valve. [Background Art] An "in-line liposome production technology" in which liposomes or lipid nanoparticles (LNPs) are continuously formed in a closed tube has been attracting attention as a technology for producing sterile liposomes, and a technology for adjusting a concentration of the thus-formed liposomes in an in-line manner has been developed (see Patent Literature 1). However, various parameters such as a flow velocity need to be adjusted in order to obtain suitable lipid particles for a factor such as a particle size, and parameters set for preparation of a small amount of a sample at a laboratory level often differ from those suitable for mass production for product supply. Therefore, in the past, conditions of manufacture for product supply had to be separately adjusted with many materials consumed. [Citation List] [Patent Literature] [PTL 1] PCT International Publication No. WO 2016/024510 [Summary of Invention] [Solution to Problem] As a result of extensive studies to find a method for reflecting conditions for preparation of a small amount of a lipid particle sample into conditions of manufacture for product supply in order to reduce a need for additional studies to determine the conditions of manufacture for product supply, the present inventors have completed an apparatus and a method of the present disclosure. Therefore, the present disclosure provides an apparatus and a method for removing a composite from a flow channel by removing a fraction by means of a dispenser including a valve. Therefore, the present disclosure provides the following items. (Item 1) A method for removing a specific fraction from a flow channel, the method including: allowing a component to flow through the flow channel;removing a fraction from a collection portion on the flow channel by means of a dispenser including a valve; anddispensing the fraction to a receiving portion. (Item 2) The method according to any of the above items, in which a time taken for removing one fraction is 1 second or less. (Item 3) The method according to any of the above items, in which the dispenser is moved at a velocity of 200 mm/sec or more in the dispensing the fraction to the receiving portion. (Item 4) The method according to any of the above items, in which the valve is a slide solenoid valve. (Item 5) The method according to any of the above items, in which the collection portion is positioned in a middle of the flow channel. (Item 6) The method according to any of the above items, in which a time taken for dispensing a fluid in one fraction to one receiving portion is 1 second or less. (Item 7) The method according to any of the above items, in which the dispensing includes dispensing a plurality of the fractions to the receiving portion including a plurality of compartments. (Item 8) The method according to any of the above items, in which a time when the fraction is removed from the collection portion is controlled based on a time and/or a flow velocity at which the component is injected into the flow channel. (Item 9) The method according to any of the above items, in which a detector detecting a state of the component is included upstream of the collection portion on the flow channel. (Item 10) The method according to any of the above items, including testing the fraction having been dispensed. (Item 11) A method for producing a formulation including a first component and a second component, the method including: providing a series of flow channels including a first flow channel through which a first fluid flows at a first flow velocity, a second flow channel through which a second fluid flows at a second flow velocity, and a third flow channel through which a third fluid flows at a third flow velocity, the third flow channel being formed by combining the first flow channel and the second flow channel at a combination portion;injecting a sample including the first component into the first flow channel at a first time;injecting a sample including the second component into the second flow channel at a second time; andremoving a fraction including a composite including the first component and the second component from the third flow channel using the method according to any of the above items;the first time and the second time being set so that the first component and the second component reach the combination portion at a time when the first component and the second component are mixed. (Item 12) An apparatus for removing a specific fraction from a flow channel, the method including: a flow channel;a dispenser attached to a collection portion on the flow channel; anda receiving portion that receives a fraction having been removed from th