Platelet Pooling and Segmentation for Therapeutic Dose Production

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Solution Overview

Problem

Current methods for collecting and preparing apheresis-derived platelet units are inefficient, as they often result in excess platelets being retained without providing additional therapeutic value, and there is a need for improved systems to maximize platelet unit production.

Innovation Solution

A method involving the collection of platelet donations by apheresis from multiple donors, pooling these donations, and separating them into a greater number of platelet units than would be possible without combination, allowing for each unit to contain a therapeutic dose of platelets, even if individual donations fall short of the minimum required for a single unit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If apheresis platelet donations are collected to meet minimum therapeutic dose criteria for one, two or three platelet units, then each unit contains the required minimum number of platelets, but excess platelets are retained without providing additional therapeutic value

Engineering Contradiction:
Improvetherapeutic dose requirementVSAvoidplatelet unit production efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent combines multiple apheresis platelet donations (singles, doubles, triples) into a pooled platelet preparation, then redistributes the pooled platelets to create additional therapeutic-dose units. This merging approach allows efficient utilization of excess platelets that would otherwise be discarded, thereby increasing overall platelet unit production while maintaining reliable therapeutic doses.

Inventive Principle:
Principle #5Merging (Combining)

2Object-affected harmful factors

If platelet collections are limited to meet specified thresholds for one, two or three platelet units, then donor safety is ensured, but the potential production capacity of platelet units is not fully captured

Engineering Contradiction:
Improvedonor safetyVSAvoidplatelet unit production potential
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The patent performs pooling of platelet donations before final unit creation, allowing advance assessment of total platelet availability. This preliminary pooling action enables the system to maximize unit production from available donations while still adhering to donor safety limits, as the pooling occurs after individual donation safety thresholds are already met.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If individual apheresis donations are processed separately to meet minimum platelet counts, then each unit meets therapeutic criteria, but fewer total units are produced compared to pooled processing

Engineering Contradiction:
Improvetherapeutic dose complianceVSAvoidnumber of platelet units
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent segments the pooled platelet preparation into multiple individual therapeutic-dose units after pooling. This segmentation approach allows the system to create the maximum number of compliant units from the pooled material, ensuring each segmented unit meets therapeutic criteria while maximizing total unit production beyond what separate processing would achieve.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3399986B1Systems and methods for preparation of platelets
Publication Date: 2023.02.22 CERUS CORP
  • EP3399986B1 patent drawingFigure 1
  • EP3399986B1 patent drawingFigure 2
  • EP3399986B1 patent drawingFigure 3

AI summary

Provided are methods, systems and compositions for the preparation of platelets, including improved methods and systems for preparing apheresis derived platelet units suitable for infusion and compositions comprising such platelet units.