Quality Control-Aibao Orui Biotechnology—GelNest™ Matrix Gel_3D Cell Culture Matrix Gel_Organoid Tumor Model Matrix Gel Manufacturer

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GelNest™ Matrigel

Quality Control

Quality

Quality Control

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Industry Challenges

Not suitable for repeated freeze-thaw cycles or long-term storage at 4°C
Significant lot-to-lot variation in endotoxin levels, protein concentration, and other parameters
High technical requirements and complex handling

NEST Advantages

SPF-Grade Animal Facility

NEST operates two standardized SPF-grade animal facilities with strict control over animal health, ensuring raw material quality at the source and supporting consistent, large-scale production of GelNest™ Matrigel.
- Full Traceability
  
  Mice sourced from certified suppliers with complete documentation
- Precise Age Control
  
  Strict donor age control ensures batch consistency
- Daily Health Monitoring
  
  Comprehensive growth and health records throughout the lifecycle
- Scalable Production Capacity
  
  Over 10,000 animals/month supporting stable industrial-scale supply
- Strict SPF Biosafety Control
  
  SPF facility compliant with national standards and health monitoring protocols
ISO Class 7 Cleanroom Manufacturing

NEST operates 10,600 m² of ISO Class 8 and 3,600 m² of ISO Class 7 cleanrooms, equipped with highly automated production lines to ensure consistent, high-quality output.
- 4°C Cold-Chain Manufacturing
  
  Produced under a controlled 4°C cold chain to preserve product activity and stability
- ISO Class 7 Cleanroom Production
  
  Manufactured in an ISO Class 7 cleanroom to minimize environmental contamination
- Sufficient Production Capacity
  
  50 L/month production capacity; >5 L per batch
- Customization Services
  
  Customized formulations and specifications are available to meet diverse research needs
- Full Traceability
  
  Every bottle of GelNest™ Matrix is traceable throughout the entire manufacturing process
End-to-End Quality Control System

NEST has established comprehensive, multi-level quality control standards with rigorous testing at every stage. Every batch undergoes strict quality inspection to ensure safe and reliable materials for a wide range of applications.
- Physical Characterization
  
  Microscopic particle inspection, viscosity measurement, and gel stability evaluation
- Microbiological Safety
  
  Bacterial screening, mycoplasma testing, and LDEV PCR testing
- Quantitative Analysis
  
  Endotoxin <4 EU/mL; protein concentration and IGF/EGF quantification
- Biological Activity Validation
  
  Validated through cell culture, organoid culture, angiogenesis, and tumor formation assays
- Protein Composition Analysis
  
  Laminin, type IV collagen, and total protein analysis

End-to-End Service

Sample Trial
Customization
Manufacturing
Filling & Packaging
Cold-Chain Delivery

Qualification Certificate

Registration Certificate – Su Medical Device Registration No. 20192080271

Registration Certificate – Su Medical Device Registration No. 20192080271

Certificate of Internationally Renowned Brand Prioritized for Cultivation and Development

Medical Device Manufacturing License

Jiangsu Medical Device Manufacturing License

Class I Medical Device Manufacturing Filing Certificate

Wuxi Specialized, Sophisticated, Distinctive and Innovative “Little Giant” Enterprise

High-Tech Enterprise Certificate

Wuxi Futeng Irradiation Technology Co., Ltd.

Wuxi Futeng Irradiation Technology Co., Ltd.

ISO 9001

Health Canada Medical Device Licence

Indonesian Imported Medical Device Registration Certificate

Indonesian Disposable Pen Certificate

Certificate of Drug Master File (DMF)

2026 FDA Registration Confirmation

Medical Device Registration Certificate

Certificate of Export Sales of Medical Devices

Environmental Management System Certificate

Trademark Registration Certificate

Intellectual Property Compliance Management System Certificate

NEST Biotechnology Co., Ltd. Intellectual Property Management System Certificate

Registration Certificate – Su Medical Device Registration No. 20192080271

North China Region
Feng Yefei： 180 5151 0772

East China Region
Jia Junyi： 180 5151 0767

South China Region
Wang Chongrui： 136 2167 8278

Central China Region
Yangsong Sang： 180 5151 0762
3061886075