Stem Cells CDMO

Service Overview | Supporting Your Clinical Research and Cell Application Strategy

“Stem Cell Contract Development and Manufacturing Services (CDMO) are supported by a professional team that assists in process design and project management, providing comprehensive services for regenerative medicine product development. These services cover: selection of research or GMP clinical sites, product construction, small-scale production of investigational cells or exosome-based drugs, production process design, establishment of raw material data, large-scale/commercial production, implementation of specialized processes/equipment, aseptic filling, packaging, and GDP-compliant transportation.

Through a flexible and customized collaboration model, combined with the expertise of the GWOXI professional team, we help clients enhance product market competitiveness, effectively reduce production line investment costs, and accelerate product launch and commercialization. This allows clients to focus on their brand core and seize market opportunities more efficiently.

Service Advantages | Clinical-Grade Quality Control

✅ Manufacturing Facilities Compliant with PIC/S GMP Standards

• Litre-Scale Production Equipment Supporting Small- to Mid-Scale Clinical Formulation Development 

✅ Core Processes and Patented Technologies

• Combined with Nigiro-Med® Stem Cell Activation Technology to Enhance Cell Viability
• Establish Multiple SOPs and Quality Standards for Stem Cell Isolation, Culture, and Preservation Processes  

✅ Experienced Professional Team

• With 20 Years of Experience in Cell Therapy Product Development
• Accumulated Extensive Clinical Collaboration Experience, Familiar with Clinical Product Development Projects and Their Risk Management  

✅ Highest Standard Quality Control

• Each Batch of Cells Undergoes Rigorous Quality Process Management 
• Generate Comprehensive Testing Reports (Viability, Sterility, Endotoxin, Phenotype) in Compliance with Clinical Trial Requirements

Contract Manufacturing Process

1. Inquiry for Requirements
Provide sample information and manufacturing requirements, which the Tracker King team will evaluate for process feasibility and conduct preliminary planning. 
 

2. Sign the Service Agreement
Confirm technical specifications, schedule, and costs, and execute the confidentiality and contract manufacturing agreement.
  

3. Sample Reception and Preprocessing
Performed according to SOP: tissue sample reception, inspection, and pre-processing prior to cell isolation.
  

4. Cell Therapy Product Manufacturing and Testing
Perform cell culture, preparation, quality testing, and final packaging.
  

5. Product Delivery and Technical Documentation Reporting
Deliver the formulation and provide comprehensive batch manufacturing and testing reports.

For further inquiries regarding collaboration or quotation, please feel free to contact us!