U.S.-Taiwan Operations and Manufacturing Platform
StemCyte operates across Taiwan and the United States, integrating Taiwan’s capabilities in cellular product development, process development, and manufacturing with U.S.-based cGMP quality management, FDA regulatory expertise, and international market resources. This cross-border platform provides a foundation spanning cellular resources, product development, and access to international markets.
Through collaboration between professional teams and quality systems in both regions, StemCyte can leverage the cellular product development and manufacturing experience established in Taiwan and, based on product characteristics and target market requirements, further align projects with U.S. regulatory requirements, clinical healthcare systems, and international collaboration networks.
Taiwan–U.S. Operations and Manufacturing Platform
| Taiwan | United States | |
|---|---|---|
| Key Locations | Linkou, Taichung | Baldwin Park, California |
| Quality & Manufacturing | TFDA GTP Cell Processing Facilities | FDA-Approved Manufacturing Facility for REGENECYTE® and cGMP Quality Management |
| Primary Functions | Cellular Product Development, Process Development, and Clinical Collaboration Support | FDA Regulatory Support, Clinical Supply, and International Collaboration |
| Platform Value | Establishing a Foundation for Cellular Product Development and Manufacturing | Connecting with U.S. Regulatory, Healthcare, and International Market Networks |
TW Taiwan | Cellular Product Development and Manufacturing
StemCyte operates cell processing facilities in Linkou and Taichung, Taiwan, that comply with TFDA GTP requirements. These facilities provide capabilities in cell and tissue processing, manufacturing, quality testing, and cryopreservation, supporting cellular material supply, clinical research, and cellular product development based on project and collaboration requirements.
StemCyte Taiwan’s cord blood bank continuously maintains AABB and FACT international accreditations and has established a comprehensive quality management system covering cell sourcing, processing, quality testing, cryopreservation, recordkeeping, and traceability.
Core Capabilities
- TFDA GTP-compliant cell processing facilities
- Cell and tissue processing and cryopreservation
- Cellular product and process development
- Cell manufacturing and quality testing
- Cell stability and quality management
- Cellular material supply and clinical collaboration support
US United States | cGMP Quality and Access to International Markets
StemCyte, Inc. was established in California in 1997 and currently operates a cGMP cellular product manufacturing facility in Baldwin Park. Over the years, StemCyte has accumulated extensive experience in cord blood quality management, clinical supply, and international transplant collaboration. StemCyte U.S.’s cord blood bank continuously maintains AABB and FACT international accreditations and completes U.S. FDA Human Cell and Tissue Establishment Registration.
In November 2024, REGENECYTE®, StemCyte’s cord blood cellular product, received U.S. FDA Biologics License Application (BLA) approval. The Baldwin Park facility is an FDA-approved manufacturing facility for REGENECYTE®, where manufacturing, quality testing, and product release are conducted in accordance with cGMP requirements.
Core Capabilities
- U.S. FDA-approved manufacturing facility for REGENECYTE®
- cGMP manufacturing processes and quality management
- Experience in FDA BLA regulatory submissions and product registration management
- Clinical trial supply and collaboration with healthcare institutions
- API cellular materials and industry collaboration
- U.S. and international licensing, commercialization, and market collaboration networks
Cross-Border Quality Collaboration and End-to-End Traceability
StemCyte’s cord blood banks in both Taiwan and the United States hold AABB and FACT international accreditations. Cell processing, testing, storage, and supply are managed in accordance with local regulatory requirements and international quality standards.
For specific tests that must be performed by internationally recognized laboratories, StemCyte has established procedures for cross-border sample transportation, outsourced testing, result review, and data retention. For example, certain samples collected in Taiwan are cryogenically packaged and transported in accordance with applicable requirements to accredited third-party laboratories in the United States for testing to meet relevant international quality standards.
Through cross-border testing, documentation management, and comprehensive traceability mechanisms, StemCyte continues to strengthen quality collaboration between its Taiwan and U.S. operations, establishing a consistent and traceable quality management foundation for cellular resources, product development, and clinical supply.
>>Learn More About International Certifications and Quality Systems
Market Value of Our Cross-Border Operations
StemCyte’s Taiwan–U.S. operations and manufacturing platform integrates cellular resources, product development, process development, quality management, regulatory expertise, and market access. Based on different stages of product development and collaboration requirements, StemCyte can provide support in cellular material supply, manufacturing, clinical collaboration, and access to international markets.
From cellular product development and manufacturing in Taiwan to cGMP quality management, FDA regulatory expertise, clinical healthcare resources, and market networks in the United States, StemCyte continues to transform decades of experience in cellular resources and cross-border operations into a platform that supports cellular product development and international business collaboration.
Frequently Asked Questions (FAQ)
StemCyte’s Taiwan operations focus on cellular product development, process development, manufacturing, quality testing, and clinical collaboration support. Its U.S. operations provide expertise in cGMP quality management, FDA regulatory affairs, clinical supply, and international market collaboration.
Yes. StemCyte’s Baldwin Park, California facility is an FDA-approved manufacturing facility for REGENECYTE®, StemCyte’s cord blood cellular product approved under BLA No. 125764. Manufacturing, quality testing, and product release for REGENECYTE® are conducted in accordance with applicable cGMP requirements.
Not necessarily. Whether a cellular product developed in Taiwan can be transferred to the United States depends on factors including the product type, intended use, development stage, manufacturing process, quality specifications, and applicable U.S. regulatory requirements. StemCyte can evaluate the appropriate regulatory, manufacturing, testing, and documentation requirements on a project-by-project basis.
StemCyte can provide project-based support covering cellular material supply, process development, manufacturing, quality testing, cross-border testing and logistics, clinical supply, regulatory coordination, and international collaboration. The specific scope of support is determined according to the product development stage, intended use, target market, and project requirements.