Core Technology

HHP (High Hydrostatic Pressure) Decellularization

A physical method that maximizes native ECM biological integrity — not a chemical process that compromises it

Why It Matters

HHP's Essence: Preserve, Not Compromise

High Hydrostatic Pressure (HHP) decellularization applies uniform isostatic pressure of 600–1000 MPa to precisely disrupt cell membranes while producing minimal perturbation to the extracellular matrix's three-dimensional protein network, growth factors, and ultrastructure. Unlike chemical methods (SDS), which rely on detergents, HHP achieves decellularization through pure physical force — no chemical residues, no chemical degradation risk, ~91% bioactive component retention. This means the ECM partners receive has bioactivity approaching that of native tissue.

From Source Tissue to High-Bioactivity ECM: Five-Step Process

01

Tissue Harvesting & Preparation

Qualified source tissues selected and pre-processed to rigorous quality standards

02

HHP Treatment — Precise Decellularization, Full ECM Preservation

Tissues undergo isostatic treatment at 600–1000 MPa. Pressure uniformly applied in all directions precisely disrupts cell membranes while ECM protein networks and ultrastructure remain fully intact — with no chemical agents involved

03

Washing & Purification — Remove Immunogens, Preserve Bioactivity

Thorough removal of cellular debris, DNA fragments, and immunogenic components while maximally preserving growth factors, matrix proteins, and bioactive signaling molecules within the ECM

04

Quality Verification

Each batch verified across multiple key quality parameters before release: DNA residue, GAG retention rate, and structural integrity testing

05

Custom Preservation & Delivery

Materials processed by lyophilization, irradiation sterilization, or wet preservation per partner requirements, balancing bioactivity and stability

Bioactive Preservation Comparison

DimensionChemical (SDS)HHP (Hopefan Biotech)
Bioactive Component Retention~20% (most active proteins chemically degraded)~91% (physical force, active components fully preserved)
ECM UltrastructureMay be compromised (detergent disrupts fiber alignment)Nanoscale preservation intact (verified by electron microscopy)
Chemical Residue RiskResidual detergent present, requires additional wash validationNo chemical residues — pure physical processing
Decellularization UniformitySurface to moderate depth; limited efficacy in thick tissueUniform isostatic pressure; equally effective across deep thick tissue
Microbial InactivationRequires separate independent sterilization stepInherent microbial inactivation capability
Processing Time24–72 hours15–60 minutes

HHP retains approximately 4.5× more bioactive components than chemical methods, with no chemical residue risk.

Patent Protection

Patents & Core Technology

Built around ECM processing and structural preservation, the company has developed a comprehensive patent portfolio.

Device Patent

High-Pressure Decellularization Equipment (HHP)

一种医用材料处理用高压设备

Method Patent

Biological Tissue Processing Method for Transplantation

一种用于移植的生物组织处理方法

Technology Patent

ECM Processing and Structural Preservation System

ECM Material Processing & Structural Preservation Technology

China GMP-certified manufacturing facility
Proprietary technology, PCT international patent filed
ISO 13485 quality system reference
Published in multiple international journals

Technical Validation

The following metrics assess decellularization efficiency and structural preservation of ECM materials

1.33ng/mg

DNA Residue

Far below the industry reference threshold (<50 ng/mg)

Test results confirm DNA residue is far below the industry safety threshold, demonstrating consistent and thorough decellularization across batches.

Third-Party Test Report

DNA Residual Test Report

Bioactivity Retention

91%

Chemical methods ~20%

Cell Removal Rate

>95%

GAG Retention

>99%

Nanostructure Preservation

Confirmed

Electron microscopy verified

Key quality indicators confirm that HHP technology achieves a stable balance between decellularization efficiency and structural preservation.

Technology Development

1998

HHP decellularization method established at Japan's National Cerebral and Cardiovascular Center

2005

HHP method refined and expanded at Tokyo Medical and Dental University

2015

Product development and regulatory filing at Japan's National Institute of Biomaterials Engineering; joint R&D with listed Japanese corporation

2021

Technology transferred to China; founding of HopeFan Biotech predecessor

2023

Hopefan Biotech established; GMP cleanroom facility built; technology commercialized

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DNA Residue: 1.33 ng/mg · Cell Removal Rate: >95%