CDMO SERVICES
Cell and Gene Therapy

Cell and Gene Therapy

 

Mycenax offers a comprehensive, one-stop CDMO service covering a broad spectrum of Allogeneic Cell and Gene Therapy (CGT) Products. We are committed to delivering total solutions that facilitate process development and GMP manufacturing of innovative CGT products, enabling our clients to expedite their products to market through our state-of-the-art, scalable closed-process platforms featuring automated and modular workflows. Mycenax's highlighted solutions include the provision of streamlined allogeneic cell sources as starting materials, ensuring our clients embark on their product development journey with the right cells.

Mycenax's Technology Platforms for Diverse Allogeneic CGT Products

 

  • Stem Cell Therapy
    • 3D MSC Manufacturing Platform
  • Immune Cell Therapy
    • NK Manufacturing Platform
    • gδ T Manufacturing Platform
  • CAR Gene Engineering Platform
    • CAR-NK
    • CAR-gδT
  • Cell Free

 

Cell and Product Type

Mycenax’s Capabilities

Mesenchymal Stem Cells (MSCs)
  • Experienced with various tissue types of MSCs (BMMSC, ADMSC, UCMSC).
  • Establishment of MCB/WCB.
  • 2D and 3D microcarrier technology platforms.
  • Closed 3D process workflow.
  • Scale-up to 50 L.
  • QC analysis for in-process and final product release testing of MSCs.

Natural killer Cells (NK)
  • NK cell types: NK-92, primary NK cells isolated from peripheral blood and umbilical cord blood.
  • Viral and non-viral gene engineering for CAR-NK.
  • Feeder-free process ensuring high purity of expanded NK cells.
  • 2D static and 3D dynamic culture processes.
  • Closed process workflow.
  • Scale-up to 50 L.
  • QC analysis for in-process and final product release testing of NK cells.

γδ T (GDT)
  • Closed 2D process workflow.
  • 10-fold linear scalability up to 15 L.
  • Gene engineering for CAR-GDT.
  • QC analysis for in-process and final product release testing of GDT.

Exosome
  • Exosome production from various tissue types of MSCs using 2D/3D culture systems.
  • Leverage scalable 3D microcarrier technology for efficient upstream production.
  • A downstream process for exosome purification through ultracentrifugation has been established; the scalable downstream processes using TFF and chromatography are under development.

 

 

OUR STRATEGIC PARTNERSHIPS

 

StemCyte supplies cell therapy materials for Mycenax’s global allogeneic cell therapy CDMO business.

Mycenax and StemCyte announce a collaboration to strengthen their one-stop service chain for allogeneic cell therapy – read our press release.

 

Keyword: Cell therapy, CGT, cell and gene therapy, gene therapy, 3D process, immune cell, NK cell, GDT cell, MSC, CDMO, CMO, GMP manufacturing
 

 

Mycenax offers a comprehensive, one-stop CDMO service covering a broad spectrum of Allogeneic Cell and Gene Therapy (CGT) Products. We are committed to delivering total solutions that facilitate process development and GMP manufacturing of innovative CGT products, enabling our clients to expedite their products to market through our state-of-the-art, scalable closed-process platforms featuring automated and modular workflows. Mycenax's highlighted solutions include the provision of streamlined allogeneic cell sources as starting materials, ensuring our clients embark on their product development journey with the right cells.

Mycenax's Technology Platforms for Diverse Allogeneic CGT Products

 

  • Stem Cell Therapy
    • 3D MSC Manufacturing Platform
  • Immune Cell Therapy
    • NK Manufacturing Platform
    • gδ T Manufacturing Platform
  • CAR Gene Engineering Platform
    • CAR-NK
    • CAR-gδT
  • Cell Free

 

Cell and Product Type

Mycenax’s Capabilities

Mesenchymal Stem Cells (MSCs)
  • Experienced with various tissue types of MSCs (BMMSC, ADMSC, UCMSC).
  • Establishment of MCB/WCB.
  • 2D and 3D microcarrier technology platforms.
  • Closed 3D process workflow.
  • Scale-up to 50 L.
  • QC analysis for in-process and final product release testing of MSCs.

Natural killer Cells (NK)
  • NK cell types: NK-92, primary NK cells isolated from peripheral blood and umbilical cord blood.
  • Viral and non-viral gene engineering for CAR-NK.
  • Feeder-free process ensuring high purity of expanded NK cells.
  • 2D static and 3D dynamic culture processes.
  • Closed process workflow.
  • Scale-up to 50 L.
  • QC analysis for in-process and final product release testing of NK cells.

γδ T (GDT)
  • Closed 2D process workflow.
  • 10-fold linear scalability up to 15 L.
  • Gene engineering for CAR-GDT.
  • QC analysis for in-process and final product release testing of GDT.

Exosome
  • Exosome production from various tissue types of MSCs using 2D/3D culture systems.
  • Leverage scalable 3D microcarrier technology for efficient upstream production.
  • A downstream process for exosome purification through ultracentrifugation has been established; the scalable downstream processes using TFF and chromatography are under development.

 

 

OUR STRATEGIC PARTNERSHIPS

 

StemCyte supplies cell therapy materials for Mycenax’s global allogeneic cell therapy CDMO business.

Mycenax and StemCyte announce a collaboration to strengthen their one-stop service chain for allogeneic cell therapy – read our press release.

 

Keyword: Cell therapy, CGT, cell and gene therapy, gene therapy, 3D process, immune cell, NK cell, GDT cell, MSC, CDMO, CMO, GMP manufacturing
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