Comprehensive Guide to Matrix Gel for Organoid Culture

On October 10, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) released the Technical Guidelines for Model-Informed Rare Disease Drug Development (Draft for Public Comment) on its official website. This document aims to gather feedback from various sectors for the formulation of national guiding standards.

In the draft, it is stated that non-clinical research data include, but are not limited to, data from genetic, molecular, cellular, organoid, organ-on-chip, and animal studies. Notably, data obtained from organoid and organ-on-chip models can also be used as sources of non-clinical research evidence.

Organoids are three-dimensional (3D) cell culture constructs derived from stem cells or progenitor cells that exhibit certain spatial tissue structures. In 2021, organoid technology was included in China’s 14th Five-Year Plan as a National Key Research and Development Project[1]. Compared to conventional 2D disease models, organoids are closer to the in vivo environment in elucidating disease progression, homeostasis, and pathogenesis, and they have broad potential applications in multiple fields such as cell therapy, drug development, genetic engineering, immunology research, and tissue regeneration.

As a critical scaffold for organoid and 3D culture, matrix gel plays an indispensable role in providing a supportive microenvironment.

Matrix Gel Overview

Matrix gel is a soluble basement membrane preparation extracted from Engelbreth-Holm-Swarm (EHS) mouse sarcoma, which is rich in extracellular matrix proteins. Its main components include laminin, type IV collagen, heparan sulfate proteoglycan (HSPG), nidogen, and multiple growth factors such as TGF-β, EGF, IGF, and FGF.

At room temperature, matrix gel polymerizes to form a biologically active 3D matrix, mimicking the structure, composition, physical properties, and functions of the in vivo basement membrane—facilitating cell culture and differentiation in vitro.

Ceturegel^TM Matrix, developed and manufactured by Yeasen Biotech, is free from lactate dehydrogenase-elevating virus (LDEV), features ultra-low endotoxin levels, and is available in various formulations: basic concentration, high concentration, reduced growth factor, and stem cell/organoid-specific types.

Applications

Product Features

High safety: LDEV-free

Varied concentrations: 8–20 mg/mL

Excellent batch-to-batch consistency: Strict production and quality control ensure stable performance

Low endotoxin: <8 EU/mL

Contaminant testing: Free of mycoplasma, bacteria, and fungi

High production capacity: ≥50 L/month

Broad compatibility: Compatible with all types of cell culture media

Tumor Sample-Based Application Validation

1. Organoid Culture Comparison Results

Sample ID	Cancer Type	Organoid Count (n)		Organoid Avg. Diameter (µm)		Culture Result		Consistency
		Experimental	Control	Experimental	Control	Experimental	Control
CRC-Y-002	Colorectal Cancer	20400	21600	124.03	127.45	succeed	succeed	yes
LC-Y-001	Lung Cancer	34800	36000	109.26	110.39	succeed	succeed	yes

CRC-Y-002

LC-Y-001

2. Pathological Identification Comparison

No.	Sample ID	Cancer Type	Sample Type	H&E Result	IHC Marker 1	IHC Marker 2	IHC Result
1	CRC-Y-002	Colorectal Cancer	Tissue & PDO	Consistent	CDX2+	CK20+	Consistent
2	LC-Y-001	Lung Cancer	Tissue & PDO	Consistent	CK7+	NapsinA+	Consistent

CRC-Y-002

LC-Y-001

3. Immunohistochemistry Comparison

(Data not provided in original text)

4. Genetic Testing Results

ID	Cancer Type	Tissue-Only Mutations	Organoid-Only Mutations	Shared Mutations	Tissue Mutations	Organoid Mutations	Shared in Tissue(%)	Shared in Organoid(%)	Std. Dev. (%)
CRC-Y-002	Colorectal Cancer	16	23	159	175	182	90.86	87.36	1.75
LC-Y-001	Lung Cancer	24	14	158	182	172	86.81	91.86	2.52

5. Drug Sensitivity Testing Results

Sample ID	Cancer Type	Control Group		Experimental Group		Result Judgment
		IC50	Sensitivity	IC50	Sensitivity
CRC-Y-002	Colorectal Cancer	2.10	Resistant	3.94	Resistant	True Negative (TN)
		1.64	Resistant	3.19	Resistant	True Negative (TN)
		1.76	Resistant	1.11	Resistant	True Negative (TN)
LC-Y-001	Lung Cancer	0.50	Sensitive	0.33	Sensitive	True Positive (TP)
		0.08	Sensitive	0.30	Sensitive	True Negative (TN)
		7.80	Resistant	5.09	Resistant	True Negative (TN)

[Note]: All above data were obtained through comparative experiments conducted by an independent, accredited third-party testing organization commissioned by Yeasen Biotech.

FAQ

1. What causes color variation (light yellow to dark red) in the matrix gel upon receipt?
For phenol red-containing matrix gels, the color change is mainly due to the interaction of phenol red and sodium bicarbonate with CO₂. After equilibrating with 5% CO₂, the color difference will be reduced. After thawing, gently swirl the vial to evenly disperse the gel.

2. What precautions should be taken when handling matrix gel?
All operations must be performed under sterile conditions. Use pre-chilled tools to ensure proper handling.

3. How should matrix gel be aliquoted and frozen for use?
After thawing Ceturegel^TM Matrix, aliquot into pre-chilled cryovials. Immediately freeze after aliquoting to avoid repeated freeze-thaw cycles.

Related Products

Product Name	Catalog No.	Specification
Ceturegel™ Matrix LDEV-Free	40183ES08/10	5/10 mL
Ceturegel™ Matrix GFR, LDEV-Free	40185ES08/10	5/10 mL
Ceturegel™ Matrix hESC-Qualified，LDEV-Free	40190ES08/10	5/10 mL
Ceturegel™ Matrix for Organoid culture, Phenol Red-Free, LDEV-Free	40192ES08/10	5/10 mL
ATP Luminescent Cell Viability Assay Kit	40210ES10/60	10/100 mL