High-Value Biopharmaceuticals Stabilized with a Simple "Mix-In" Method Using Nanoparticle Hydrogel Technology: Development of the Biomolecule Preservation and Stabilization Platform "Gel CoatTM"

Gel Coat Biomaterials Inc. (Headquarters: Chiyoda-ku, Tokyo; CEO: Shin Yoshida; hereinafter referred to as "GCB") is advancing the research and development of its biomolecule preservation and stabilization platform, "Gel CoatTM," based on its proprietary nanoparticle hydrogel technology.

"Gel CoatTM" is a platform technology that aims to improve the preservation stability of biomolecules such as enzymes, proteins, and antibodies used in biopharmaceuticals, vaccines, regenerative medicine products, and diagnostic agents, through a simple "mix-in" approach without chemically modifying the active ingredient itself.

In verification using enzymes, it was confirmed that under "Gel CoatTM" formulation conditions, enzymes that previously required ultra-low temperature freezing at -30°C maintained over 80% of their activity after 28 days at 4°C. Furthermore, over 60% of activity was maintained under room temperature conditions, and some activity remained even under high temperatures of 37°C, close to body temperature.

This technology and GCB's business development were recently featured in "Nikkei Biotech," a specialized media outlet in the life science field. The article introduces the technical features of "Gel CoatTM," as well as its safety evaluation with human application in mind, its potential to reduce cold chain dependency, and its partnering activities for joint research and licensing.

Challenges of "Preservation Stability" and Cold Chains Hindering the Spread of Biopharmaceuticals

Biopharmaceuticals and bio-derived products such as antibody drugs, vaccines, enzyme preparations, and regenerative medicine-related products, while offering high therapeutic effects and functionality, are susceptible to heat and storage environments, requiring strict temperature control at all stages of manufacturing, storage, and transportation.

Consequently, maintaining a cold chain centered on refrigerated and frozen logistics has become indispensable, leading to challenges such as rising logistics costs, limitations on supply regions, quality maintenance during power outages and disasters, and supply to low- and middle-income countries.

Traditionally, methods such as modifying the active ingredient itself or formulation technologies like freeze-drying have been used to address these challenges. However, these approaches carried risks of reduced activity due to molecular modification, increased complexity of manufacturing processes, and additional equipment and cost increases, impacting product development speed and profitability.

What is Gel CoatTM? A Platform Technology Aiming to Improve Preservation Stability with a Simple "Mix-In" Method

"Gel CoatTM" is a biomolecule preservation and stabilization platform based on the nanoparticle hydrogel technology developed by GCB. It is a novel approach that enhances preservation stability through simple formulation design without chemically modifying the drug or active ingredient itself.

Since the molecular structure of the active ingredient is not altered, it is expected to suppress degradation during preservation while maintaining the inherent function and activity of the biomolecule. Another significant feature is its ease of integration into existing manufacturing processes, requiring no special equipment or major process changes.

"Gel CoatTM" is not limited to a single product but is a platform technology that can be applied across multiple markets where preservation stability is a challenge. Through "Gel CoatTM," GCB aims to provide new options for the preservation, transportation, and utilization of biomolecules.

Item

"Gel CoatTM" Features

Underlying Technology

GCB's proprietary nanoparticle hydrogel technology

Approach

Aims to improve preservation stability through formulation design without chemically modifying the active ingredient

Usage Method

Can be introduced with a simple "mix-in" method

Manufacturing Compatibility

Likely to be easily integrated into existing manufacturing processes, minimizing the need for major process changes

Expected Effects

Reduces the risk of degradation during preservation while maintaining the inherent activity and function of biomolecules

Application Potential

Applicable to a wide range of fields including pharmaceuticals, diagnostics, regenerative medicine, high-performance cosmetics, and industrial enzymes

Difference from Traditional Approaches

While aiming to improve preservation stability, "Gel CoatTM" is characterized by not altering the active ingredient itself, its ease of integration into existing processes, and its simple "mix-in" introduction.

Comparison Item

Challenges Prone to Traditional Technologies

"Gel CoatTM" Approach

Impact on Active Ingredient

Activity reduction or development risks may arise from molecular modification

Does not chemically modify the active ingredient itself

Manufacturing Process

Processes may become complex due to freeze-drying or special procedures

Aims for application to existing processes through simple formulation design

Equipment Investment

Additional equipment or process changes may be required

Potential to minimize major equipment changes

Application Expansion

Individual optimization may be required for each product

Platform technology applicable across multiple markets

Ease of Introduction

Specialized formulation processes may be required

Intuitive and simple "mix-in" approach

Verification Results: Over 80% Enzyme Activity Maintained After 28 Days at 4°C

In enzyme verification, when using "Gel CoatTM," it was confirmed that over 80% of enzyme activity was maintained at 4°C after 28 days, for enzymes that previously required ultra-low temperature freezing at -30°C. Furthermore, over 60% activity was maintained under room temperature conditions, and some activity remained even at high temperatures of 37°C, close to body temperature.

While activity significantly decreased during the preservation period under conventional conditions, activity maintenance was confirmed solely through formulation design under "Gel CoatTM" formulation conditions. This indicates its potential as a new option for the preservation and logistics of pharmaceuticals and bio-derived ingredients.

Figure 1: Comparison of Enzyme Activity Maintenance Rates Under Conventional Storage Conditions and "Gel CoatTM" Formulation Conditions / Over 80% activity maintenance was confirmed after 28 days at 4°C under "Gel CoatTM" formulation conditions. Left: Conventional conditions without "Gel CoatTM". Right: Conditions with "Gel CoatTM" added.

Business Impact: Potential Contribution to Reduced Manufacturing, Logistics, and Storage Costs

"Gel CoatTM" has the potential to impact the development, manufacturing, and logistics cost structure of biopharmaceuticals and bio-derived products, going beyond mere formulation improvement.

If stabilization can be achieved without modifying the active ingredient, it may reduce development risks and additional processes associated with molecular modification. Furthermore, reducing reliance on freeze-drying and strict frozen logistics can lead to cost savings in manufacturing, storage, and transportation.

"Gel CoatTM" has the potential to contribute to reduced transportation costs, simplified storage, and expanded supply regions by enhancing the preservation stability of such products.

Moreover, it is expected to contribute to stable supply of pharmaceuticals and bio-derived products in environments where maintaining stable refrigerated and frozen equipment is difficult, such as during disasters or power outages.

Anticipated Application Areas

"Gel CoatTM" is expected to be co-developed in the pharmaceutical, medical, cosmetic, and industrial biotechnology fields as a platform technology applicable across multiple markets where preservation stability is a challenge.

- Antibody drugs, biopharmaceuticals

- Vaccines, enzyme preparations

- Regenerative medicine-related products, cell products

- High-performance cosmetics, exosome formulations

- Industrial enzymes, biocatalysts

- Research reagents, biomaterials

About the "Gel CoatTM" Brand

"Gel CoatTM" is a platform brand based on nanoparticle hydrogel technology developed by Gel Coat Biomaterials.

In addition to preservation stabilization technology, we are advancing research and development as a technology platform that enables a wide range of applications from the life sciences field to industrial uses, including non-specific adsorption inhibition and surface modification technologies.

Through the "Gel CoatTM" brand, GCB will promote new social implementation of biomaterial technology.

About Gel Coat Biomaterials Inc.

As a startup originating from the University of Tokyo, our company is promoting the research and development of proprietary biomaterial technology and surface functionalization technology "Gel CoatTM". We provide innovative solutions for realizing a sustainable society and solving industrial challenges, including the "technology to stabilize biomolecules using biocompatible amoeba hydrogels".

<<Company Profile>>

Established: January 16, 2024

Representative Director / Co-founder: Shin Yoshida

Co-founder: Professor Madoka Takai, Department of Bioengineering, Graduate School of Engineering, The University of Tokyo

E-mail: [email protected]

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