2025/09/18
Editorial Column
Taiwan Exosome Achieves MOHW GTP Certification, Expands into Clinical-Grade NK Cell Production to Drive Growth in Regenerative Medicine
Taiwan Exosome Co., Ltd.
Clinical-Grade NK Cell Manufacturing Platform
Obtained GTP (Good Tissue Practice) certification from the Ministry of Health and Welfare.
First in Taiwan and seventh worldwide capable of providing clinical-grade, universal, non-matching, non-gene-modified NK cells.
Supports clinical research and immunotherapy technology validation, accelerating international collaboration within Taiwan’s cell therapy industry.
Regulatory Advantage × Regenerative Medicine Growth Opportunity
Taiwan conditionally legalized cell therapy in 2018, becoming the second country worldwide to establish such a regulatory framework.
Over 60 companies have since entered the regenerative medicine sector.
Taiwan Exosome is at the forefront, establishing a clinical-grade NK cell manufacturing platform under GTP approval.
“Dual-Track Integration × Three Arrows” Strategy
Advancing two major platforms in parallel: immune cells and exosomes.
Building cross-domain R&D pipelines spanning plant, animal, and human sources.
Established a modular exosome platform covering the entire value chain: healthcare product development → bio-application research → clinical technology validation.
Strengthening international collaboration potential through industry–academia–medical alliances.
Clinical Partnerships and Data Accumulation
Collaborations with Linkou Chang Gung Memorial Hospital and National Cheng Kung University Hospital.
Conducting technical validation and data collection using autologous and universal NK cell products.
All processes are executed in compliance with TFDA (Taiwan Food and Drug Administration) and IRB reviews.
Market Opportunity
NK cell market projected to grow rapidly with a 43.1% CAGR through 2030.
Exosome market expected to reach USD 4.37 billion by 2037.
Operating in high-barrier, high-growth sectors, Taiwan Exosome is expanding its global presence through a “Diversified R&D + Clinical Collaboration” strategy.
Outlook: From Taiwan to the World
Dr. Chieh-Liang Lin (COO & CTO):
“Securing GTP certification is a critical milestone for our company. Moving forward, we will continue to deepen collaborations with international clinical institutions, accelerate applied research on exosome and immune cell platforms, and enhance Taiwan’s global presence in regenerative medicine.”
Source: innews.com.tw
Clinical-Grade NK Cell Manufacturing Platform
Obtained GTP (Good Tissue Practice) certification from the Ministry of Health and Welfare.
First in Taiwan and seventh worldwide capable of providing clinical-grade, universal, non-matching, non-gene-modified NK cells.
Supports clinical research and immunotherapy technology validation, accelerating international collaboration within Taiwan’s cell therapy industry.
Regulatory Advantage × Regenerative Medicine Growth Opportunity
Taiwan conditionally legalized cell therapy in 2018, becoming the second country worldwide to establish such a regulatory framework.
Over 60 companies have since entered the regenerative medicine sector.
Taiwan Exosome is at the forefront, establishing a clinical-grade NK cell manufacturing platform under GTP approval.
“Dual-Track Integration × Three Arrows” Strategy
Advancing two major platforms in parallel: immune cells and exosomes.
Building cross-domain R&D pipelines spanning plant, animal, and human sources.
Established a modular exosome platform covering the entire value chain: healthcare product development → bio-application research → clinical technology validation.
Strengthening international collaboration potential through industry–academia–medical alliances.
Clinical Partnerships and Data Accumulation
Collaborations with Linkou Chang Gung Memorial Hospital and National Cheng Kung University Hospital.
Conducting technical validation and data collection using autologous and universal NK cell products.
All processes are executed in compliance with TFDA (Taiwan Food and Drug Administration) and IRB reviews.
Market Opportunity
NK cell market projected to grow rapidly with a 43.1% CAGR through 2030.
Exosome market expected to reach USD 4.37 billion by 2037.
Operating in high-barrier, high-growth sectors, Taiwan Exosome is expanding its global presence through a “Diversified R&D + Clinical Collaboration” strategy.
Outlook: From Taiwan to the World
Dr. Chieh-Liang Lin (COO & CTO):
“Securing GTP certification is a critical milestone for our company. Moving forward, we will continue to deepen collaborations with international clinical institutions, accelerate applied research on exosome and immune cell platforms, and enhance Taiwan’s global presence in regenerative medicine.”
Source: innews.com.tw