Keratin YK93-2 Expression Platform for Pharmaceutical Production

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Solution Overview

Problem

Existing technologies have overlooked the potential of hard keratins, which are abundant but often discarded as waste, and there is a lack of effective methods to utilize them in biopharmaceutical applications.

Innovation Solution

The development of keratin YK93-2, a nucleic acid molecule encoding keratin YK93-2, and an expression vector integrated into host cells, allowing for the production of keratin YK93-2 through fermentation and purification processes, which can be used in pharmaceutical compositions for treating conditions like prostatic hyperplasia, lung cancer, lymphoma, melanoma, and breast cancer.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of substance

If hard keratin is used as a waste material, then resource utilization is low, but production cost is reduced

Engineering Contradiction:

Improvehard keratin utilizationVSAvoidproduction complexity

Core Design Contradiction:

Loss of substanceVSEase of manufacture

Solution Approach 1:

The patent converts waste hard keratin materials into valuable pharmaceutical products by expressing keratin proteins through recombinant DNA technology in host cells, transforming previously discarded resources into therapeutic agents for treating various diseases

Inventive Principle:

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

Solution Approach 2:

The patent introduces expression vectors and host cells as intermediaries to produce keratin proteins, bridging the gap between waste keratin materials and pharmaceutical applications through controlled biological expression systems

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If keratin is used for pharmaceutical applications, then therapeutic efficacy is improved, but manufacturing complexity increases

Engineering Contradiction:

Improvetherapeutic effectVSAvoidexpression system complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent creates a universal keratin expression system that can produce multiple different keratin protein variants with various therapeutic functions, allowing a single expression platform to address multiple disease conditions including cancer, cardiovascular disease, and neurological disorders

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent modifies keratin protein sequences through genetic engineering to optimize expression levels, solubility, and therapeutic activity, demonstrating how parameter changes in protein structure can enhance pharmaceutical efficacy while maintaining manufacturability

Inventive Principle:

Principle #35Parameter changes

3Loss of substance

If hard keratin resources are utilized through traditional methods, then resource waste is reduced, but production yield is low

Engineering Contradiction:

Improvekeratin resource utilizationVSAvoidkeratin production yield

Core Design Contradiction:

Loss of substanceVSProductivity

Solution Approach 1:

The patent uses recombinant DNA technology to create copies of keratin genes in host cells, enabling mass production of keratin proteins through biological replication rather than relying on limited natural sources or traditional extraction methods

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent replaces traditional mechanical extraction and purification methods with biological expression systems that naturally produce keratin proteins, substituting complex physical processing with controlled cellular synthesis for higher efficiency and yield

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 keratin YK93-2 demonstrates significant efficacy in reducing prostate wet weight, inhibiting cancer proliferation, increasing serum prolactin levels, and providing analgesic effects, showcasing its potential as a therapeutic agent.

Implementation Method 1

a nucleic acid molecule encoding the keratin YK93-2

Methodology Applied

Scientific EffectGene expression:

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 EffectProtein synthesis:

Implementation Method 3

preparation methods of the keratin YK93-2... which comprises the following steps: A. Synthesizing the nucleic acid molecule corresponding to the keratin YK93-2... culturing the host cell with the expression vector in fermentation equipment under certain conditions and inducing expression of keratin YK93-2

Methodology Applied

Scientific EffectFermentation: Fermentation

Implementation Method 4

B. Separating, purifying and drying the crude protein solution expressed in step A to obtain keratin YK93-2

Methodology Applied

Scientific EffectProtein purification: Purification

Data Source

PatentEP4600261A1Keratin YK93-2, and preparation method therefor, pharmaceutical composition thereof and use thereof

Publication Date: 2025.08.13 INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI

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AI summary

The present invention belongs to the field of biopharmaceuticals. Provided are a keratin YK93-2, a nucleic acid molecule encoding the same, an expression vector comprising the nucleic acid molecule, a host cell comprising the expression vector or the genome integrated with the nucleic acid molecule, a preparation method therefor and a pharmaceutical composition thereof. Further provided is the use of the above-mentioned product, such as keratin YK93-2 in the preparation of a drug for treating lung cancer, lymphoma, breast cancer, melanoma, uterine fibroid, prostatic hyperplasia etc.