CytoNiche

PRODUCTS

3D Intelligent Manufacturing Platform for Cells

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3D FloTrix<sup>®</sup> vivaFILL Cell Filling System

3D FloTrix^® vivaFILL Cell Filling System

3D TableTrix^® Microcarriers

3D RecomTrix ™ Recombinant Collagen Microcarriers

3D FloTrix<sup>®</sup> vivaPREP Cell Processing System

3D FloTrix^® vivaPREP Cell Processing System

3D FloTrix<sup>®</sup> vivaPREP PLUS Cell Harvesting System

3D FloTrix^® vivaPREP PLUS Cell Harvesting System

3D FloTrix<sup>®</sup> vivaEXO Exosome Harvesting System

3D FloTrix^® vivaEXO Exosome Harvesting System

3D FloTrix<sup>®</sup> microSPIN 6-channel micro-bioreactor

3D FloTrix^® microSPIN 6-channel micro-bioreactor

3D FloTrix<sup>®</sup> vivaPACK Cell Filling System

3D FloTrix^® vivaPACK Cell Filling System

3D FloTrix® mesenchymal stem cell serum-free medium

3D FloTrix<sup>®</sup> miniSPIN Bioreactor

3D FloTrix^® miniSPIN Bioreactor

3D FloTrix<sup>®</sup> vivaROCK Disposable Bioreactor

3D FloTrix^® vivaROCK Disposable Bioreactor

3D ExoTrix Exosome

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QUALIFICATIONS

The 3D microcarrier has obtained the qualifications for pharmaceutical excipients from CDE and FDA

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FDA MF：29721

FDA DMF：037798

FDA DMF：035481

CDE approval registration number: F20210000003, F20210000496

Obtained the safety evaluation report from an authoritative third-party

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SERVICE AND APPLICATION

Providing expansion practice of 3D large-scale culturing

Solutions

Holistic Solution for Virus Production with 3D Dissolvable Porous Microcarriers
Overall Solution for Large-scale Culture and Preparation of Stem Cells
Overall Solution for Large-scale Culture and Preparation of Exosomes

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CDMO

CDMO Overall Solution for Mesenchymal Stem Cell Therapy Products
Overall Solution for Preparation, Separation and identification of Exosomes

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Technical Services

Overall solution for large-scale cell expansion
Overall solution for large-scale preparation of exosomes

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Validation Services

3D culture process validation of high-quality cells
Validation services of exosomes collected from the 3D cultured cells

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Process Development

Large-scale preparation process and quality control of stem cells
Overall solution for stem cell clinical research filing and IND application
Customized process development for exosomes

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About us

Mission:

Empowering cell and gene therapy development with intelligent 3D cellular mass manufacturing technology to benefit more patients

Scientific Innovation

Vision:

Launching a New Era in Cell Industrialization

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Core values:

Win-win Integrity Innovation Focus High-quality

LATEST NEWS

Learn about the latest information about CytoNiche

【Billion-Level Stem Cells Production】 On-site GMP Bootcamp Training Program was Successfully Held

 Time of issue: 2023-09-20

Cellular "Smart" Drugs, Future Therapies | CytoNiche: Never Stops, Empowering the Development of CGT Industry

 Time of issue: 2023-08-28

CytoNiche Biotech's 3D TableTrix® Microcarrier Receives FDA-DMF Type II Qualification Filing Again

 Time of issue: 2023-07-27

New! CytoNiche Biotech's 3D TableTrix® Microcarrier Receives 【FDA-DMF】 Qualification Filing

 Time of issue: 2023-07-25

Application of Novel 3D Porous Biodegradable Microcarrier in the Vaccine Field

 Time of issue: 2023-07-11

【Billion-Level Stem Cells Production】 On-site GMP Bootcamp Training Program was Successfully Held

CytoNiche Bio's inaugural "Billion-Level Stem Cell Production " bootcamp training program was successfully concluded at the CytoNiche’s Shanghai Center of Excellence (CoE) from August 15th to 22nd. This year, the bootcamp developed an interactive and immersive GMP setting to bring more than 20 technical elites from stem cell companies in China as well as, international participants. The bootcamp consisted of a mix of plenary training modules and lectures and interactive break-out sessions in smaller, more focused groups. The training was led by CytoNiche’s experts providing tips and feedback on scaling-up stem cells production and potential technical difficulties encountered by customers.

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