Cryopreserved ECP-Treated Mononuclear Cells for Flexible Administration

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Solution Overview

Problem

Current ECP treatment procedures require repeated apheresis collections and UV irradiation of mononuclear cells, which is logistically challenging and affects the therapeutic properties of cryopreserved cells upon thawing, limiting the convenience and effectiveness of ECP-based therapies.

Innovation Solution

An apparatus and method for cryopreserving ECP-treated mononuclear cells using a photoactive compound like 8-methoxypsoralen, followed by UV exposure and combination with a cryopreservation medium, allowing for the storage of therapeutic portions that retain apoptotic properties upon thawing, reducing the need for frequent apheresis and UV treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mononuclear cells are cryopreserved after ECP treatment, then the therapeutic properties and apoptotic trend are preserved, but the logistical complexity and cost of repeated apheresis collections increase

Engineering Contradiction:
Improvetherapeutic properties retentionVSAvoidlogistical complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by performing ECP treatment on mononuclear cells before cryopreservation. The cells are treated with photoactive compounds and UV irradiation in advance, then frozen for later use. This allows the therapeutic properties to be established beforehand, eliminating the need for repeated apheresis and treatment procedures while maintaining the apoptotic trend upon thawing and reinfusion.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If repeated apheresis collections are performed for ECP treatment, then therapeutic effectiveness is maintained, but patient burden and treatment time increase

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidtreatment time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs ECP treatment in advance on collected mononuclear cells, then cryopreserves them for later administration. This preliminary treatment approach eliminates the need for repeated apheresis collections and UV irradiation sessions, significantly reducing treatment time while maintaining therapeutic effectiveness through the preserved apoptotic properties of the treated cells.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent creates a stable, storable copy of the therapeutic effect by cryopreserving ECP-treated cells. Instead of repeatedly producing the same therapeutic effect through multiple apheresis and treatment cycles, the treated cells serve as a stable repository that can be thawed and reinfused later, copying the therapeutic benefit without requiring repeated procedural intervention.

Inventive Principle:
Principle #26Copying

3Adaptability or versatility

If ECP-treated cells are cryopreserved and thawed, then flexible administration schedules are enabled, but the apoptotic properties may be compromised

Engineering Contradiction:
Improveadministration flexibilityVSAvoidapoptotic properties
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent applies beforehand cushioning by optimizing the cryopreservation protocol to protect the apoptotic properties of ECP-treated cells during freezing and storage. Specific cryoprotectants and controlled freezing rates are used to minimize cellular damage, ensuring that the apoptotic trend is preserved upon thawing. This preparatory protection allows flexible administration schedules without compromising therapeutic effectiveness.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The method allows for the preservation of therapeutic properties, including apoptosis trend, in cryopreserved and subsequently thawed ECP-treated mononuclear cells, enabling more flexible administration schedules and reducing the burden of repeated treatments on patients and clinicians.

Implementation Method 1

combining a mononuclear cell product with a photoactive compound that is activated by exposure to light of a selected wavelength... The combination of 8-MOP and UV radiation encourages and/or causes apoptosis or programmed cell death

Methodology Applied
Scientific EffectPhotochemical reaction: Photopolymerisation

Implementation Method 2

combining therapeutic portions of the treated product with a cryopreservation medium and cryopreserving therapeutic portions of the treated mononuclear cell product... allow the collected portions of ECP treated mononuclear cell products to be divided into smaller portions for more (or less) frequent administration

Methodology Applied
Scientific EffectCryopreservation: Freezing

Data Source

PatentEP2641623B1Apparatus and methods for providing cryopreserved ecp-treated mononuclear cells
Publication Date: 2020.09.30 FENWAL INC
  • EP2641623B1 patent drawingFigure 1
  • EP2641623B1 patent drawingFigure 2
  • EP2641623B1 patent drawingFigure 3

AI summary

An apparatus and method for providing cryopreserved mononuclear cells that have been treated by extracorporeal photopheresis ("ECP") is disclosed. More specifically, the present disclosure relates to providing ECP treated mononuclear cells that retain their apoptotic properties after cryopreservation and subsequent thawing.