Company
Business
Stem Cell Therapy
Organoid
CDMO Business
Extensive Manufacturing Technologies and Expertise
- Proven expertise in isolation technologies for various human-derived tissues
- Advanced large-scale cell expansion (large-scale culture) capabilities
- Proprietary freeze formulation technologies for pharmaceutical products
- Over 10 years of GMP-compliant operational and manufacturing experience in cell therapy (including extensive experience in clinical trials and regulatory inspections)
State-of-the-Art GMP Facilities Compliant with Global Standards
- Standalone manufacturing facilities
- Flexible, customized manufacturing suites
(production rooms allocated based on culture scale) - Fully licensed GMP facilities, including:
- Manufacturing license for Advanced Biopharmaceuticals
- Human Cells and Tissues Management Business license
- Licensed Cell Processing Facility (licensed under the Act on Advanced Regenerative Medicine and Advanced Biopharmaceuticals of Korea)
- Licensed manufacturing site for specified cell-processed products
CDMO services
Contract development
- Establishment of culture scale and manufacturing process
- Large-scale cell culture process development
- Definition of quality control (QC) items and specifications
- Stability studies (long-term storage), including definition of test parameters and storage conditions
Contract Manufacturing
- Manufacturing of cell therapy products, including:
- Autologous and allogeneic cell therapies
- Stem cell therapies
- Gene-modified cell therapies
(Non-viral method) - Immune cell therapies
- Exosome-based products (research or clinical use)
- Cell culture media
- Cell Banking Services (MCB/WCB)
- Quality testing for cell therapy products
- Aseptic process validation
- Stability studies (long-term storage)
Clinical Research for Advanced Regenerative Medicine
- Clinical manufacturing for studies using autologous and allogeneic cells
- Cell processing and customized dispensing/filling for small-scale and multi-product clinical studies
- GMP-compliant cell processing and assurance of aseptic environments (operation of licensed cell processing facilities)
- Preparation of documentation and test reports in accordance with regulatory requirements for advanced regenerative medicine clinical research
Contract Development for Filling and Cryopreservation
- Pharmaceutical filling services Based on M1 Filling Station
- Control of homogenization conditions
- Control of filling and dispensing parameters
- Cryopreservation of cell therapy products CRF-based cryopreservation
- CRF cycle
CDMO Service Process
CDMO Service Inquiry
For CDMO-related inquiries and requests, please click the “CDMO Service Inquiry Download” button on the bottom, complete the inquiry form, and send it to us via email at sales@kangstem.com. Our team will review your request and respond with detailed information.
# To ensure prompt handling, please include “[CDMO]” at the beginning of your email subject line.
(e.g., [CDMO] Inquiry regarding CDMO services)