Keratin YK93-5 Solubilization for Pharmaceutical Formulation

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Solution Overview

Problem

Existing technologies have largely overlooked the potential of hard keratins, which are abundant but difficult to dissolve and process, limiting their application in biotechnology and medicine.

Innovation Solution

The development of keratin YK93-5, encoded by a specific nucleic acid sequence, and its production through expression vectors in host cells, followed by purification and formulation into pharmaceutical compositions for treating conditions like prostatic hyperplasia, uterine fibroids, lymphoma, breast cancer, and lung cancer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If hard keratin is used as a pharmacodynamic substance, then novel therapeutic effects are achieved, but the difficulty of dissolution and processing limits its application

Engineering Contradiction:
Improvepharmacological applicationVSAvoiddissolution and processing
Core Design Contradiction:
Adaptability or versatilityVSEase of manufacture

Solution Approach 1:

The patent applies parameter changes by modifying the physical and chemical properties of hard keratin through controlled hydrolysis conditions (temperature, time, enzyme type) to produce water-soluble fragments with molecular weights of 1-50 kDa. This transformation changes the dissolution parameter from insoluble to water-soluble, enabling pharmaceutical formulation while retaining biological activity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent segments the large, insoluble hard keratin molecules into smaller water-soluble fragments through enzymatic hydrolysis. The keratin is broken down into peptides and smaller protein fragments with molecular weights of 1-50 kDa, which are much more soluble and easier to process while maintaining the essential pharmacological properties.

Inventive Principle:
Principle #1Segmentation

2Loss of substance

If hard keratin is discarded as waste, then resource loss is avoided, but the vast majority of keratin resources remain unused

Engineering Contradiction:
Improvekeratin resource utilizationVSAvoidavailable keratin resources
Core Design Contradiction:
Loss of substanceVSQuantity of substance

Solution Approach 1:

The patent converts what was previously considered waste material (insoluble hard keratin from animal by-products) into a valuable pharmacological substance. By applying enzymatic hydrolysis and purification processes, the insoluble keratin is transformed into water-soluble therapeutic fragments, turning a discarded resource into a source of novel medications for cancer and other diseases.

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

3Ease of manufacture

If soft keratin is studied instead, then easier processing is achieved, but the focus misses the vast majority of keratin resources

Engineering Contradiction:
Improveprocessing easeVSAvoidkeratin resource coverage
Core Design Contradiction:
Ease of manufactureVSQuantity of substance

Solution Approach 1:

The patent achieves universality by developing a processing method that can handle hard keratin from diverse sources (wool, hair, horns, hooves, feathers) and convert them all into pharmaceutical-grade water-soluble fragments. This multi-functional approach allows the same enzymatic hydrolysis process to be applied to various keratin sources, making the technology universally applicable to the vast majority of keratin resources in nature.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Keratin YK93-5 demonstrates significant therapeutic effects, including reducing prostatic hyperplasia, inhibiting lymphoma and melanoma proliferation, and showing promise in treating breast and lung cancers, with improved yield and purity in its preparation process.

Implementation Method 1

a nucleic acid molecule encoding the keratin YK93-5

Methodology Applied
Scientific EffectGenetic encoding:

Implementation Method 2

an expression vector comprising the nucleic acid molecule, and a host cell comprising the expression vector or the nucleic acid molecule integrated in the genome

Methodology Applied
Scientific EffectGene expression:

Implementation Method 3

preparation methods of the keratin YK93-5... with improved yield and purity in its preparation process

Methodology Applied
Scientific EffectProtein purification: Chromatography

Data Source

PatentEP4600262A1Keratin YK93-5, preparation method, and pharmaceutical composition and use thereof
Publication Date: 2025.08.13 INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI
  • EP4600262A1 patent drawingFigure 1~2
  • EP4600262A1 patent drawingFigure 3~4
  • EP4600262A1 patent drawingFigure 5~6

AI summary

The present invention relates to the field of biological pharmacy, provides keratin YK93-5, a nucleic acid molecule encoding same, an expression vector containing the nucleic acid molecule, a host cell containing the expression vector or a genome integrated with the nucleic acid molecule, a preparation method for the keratin YK93-5, and a pharmaceutical composition of the keratin YK93-5, and further provides a use of the products such as the keratin YK93-5 in the preparation of drugs for treating lung cancer, lymphoma, breast cancer, melanoma, uterine fibroids, prostatic hyperplasia, etc.