Human Growth Factor Concentrate from Expired Platelets

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Solution Overview

Problem

Existing methods for isolating growth factors from platelets result in substantial variability of growth factor concentration and require fresh platelets with a short shelf life, limiting their use in pharmaceutical production.

Innovation Solution

A method involving the collection of platelet lysates, inactivation of viruses, and concentration of growth factors through nanofiltration, utilizing expired platelets to create a standardized human growth factor concentrate suitable for pharmaceutical use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fresh platelets are used for growth factor isolation, then growth factor concentration can be obtained, but shelf life is limited and variability is substantial

Engineering Contradiction:

Improvegrowth factor concentration consistencyVSAvoidplatelet shelf life

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent applies preliminary action by collecting and storing platelets in advance before they expire, then processing them afterward to extract growth factors. This allows the use of expired platelets that would otherwise be discarded, extending the effective time window for growth factor production while maintaining consistent concentrations through standardized processing protocols.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary processing step where expired platelets are lysed and processed through a standardized extraction protocol. This intermediary process transforms the unusable expired platelets into a reliable source of growth factors, mediating between the limitation of short shelf life and the need for consistent growth factor supply.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If single donor platelet concentrate is used, then growth factors can be isolated, but variability of concentration is substantial

Engineering Contradiction:

Improvegrowth factor concentration consistencyVSAvoidmanufacturing scalability

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent merges platelet concentrates from multiple donors into a pooled preparation before processing. This combining approach averages out individual donor variability, resulting in more consistent growth factor concentrations across batches. The pooled platelets are then processed together through lysis and extraction, improving both reliability and manufacturing efficiency.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The patent changes the parameter of donor composition from single-donor to multi-donor pooled preparations. This parameter change fundamentally alters the variability profile, transforming highly variable single-donor products into consistent pooled products with predictable growth factor concentrations, enabling reliable pharmaceutical manufacturing.

Inventive Principle:

Principle #35Parameter changes

3Object-affected harmful factors

If traditional virus elimination methods are used, then safety can be achieved, but processing time and complexity increase

Engineering Contradiction:

Improvevirus contaminationVSAvoidprocessing steps

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates viruses through a dedicated virus elimination step that removes viral contaminants from the platelet lysate. This targeted extraction approach efficiently addresses virus contamination without requiring complex multi-step processing, maintaining simplicity while ensuring safety.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent converts the potential harm of virus contamination into a controlled elimination process. By deliberately implementing a virus elimination step, the method transforms the risk of viral contamination into a verified safety feature, demonstrating that the processing step removes harmful agents while maintaining the beneficial growth factors.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 provides a stable and consistent human growth factor concentrate with reduced variability, extending the storage period and addressing the shortage of fresh platelets, suitable for industrial-scale manufacturing and safe for intracutaneous injection.

Implementation Method 1

generating a filtrate by passing the solution from step (b) through a nanofilter as a second virus elimination step

Methodology Applied

Scientific EffectNanofiltration: Filter (physical)

Implementation Method 2

separating the platelet lysate into a supernatant and a pellet

Methodology Applied

Scientific EffectUltracentrifugation: Centrifugal Separation

Data Source

PatentUS20250360168A1Methods for making human growth factor concentrate and compositions and uses thereof

Publication Date: 2025.11.27 GMS CAPITAL PARTNERS LLC

AI summary

The present disclosure relates to methods for making platelet derived human growth factor concentrate and related therapeutic and pharmaceutical compositions and uses thereof. Methods of use of the therapeutic and pharmaceutical compositions are also provided herein.