Industrial Technology Research Institute

Technology Overview

Adipose-derived stem cells are very rare in the body and must be expanded in vitro to obtain sufficient cells for stem cell therapy. Our medium can proliferate 100 times in 5 days, and the seeding cell density can be less than 300 cells per square centimeter. The chemically defined property can greatly improve the safety and feasibility of its clinical application.

ITRI's factory obtained the GMP registration of Class II medical devices. The products have also obtained the Class II medical device license. This factory is the first culture medium R&D and production center in Taiwan. Our mesenchymal stem cells (MSCs) isolation and mass production technology can harvest about 4,666 therapeutic doses from 1g of adipose tissue cultured for 21 days, which is about 11,200 times higher than the serum-containing system, shortening the culture time by 15 days.

This technology has been successfully applied to pet medical treatment. Many dogs and cats who are paralyzed even return to their original healthy state. Our technology has also been recognized and published in several international journals, showing that our technology has matured.

• Features
  • The SFM for MSCs is a high-efficiency proliferation medium with chemically defined formula and seeding with low cell density.
  • This technology can obtain a large amount of MSCs for cell therapy in a short time.
  • The efficacy of MSCs is proven by pet clinical trials testing and has profound clinical application value.
  • ITRI's medium production factory has obtained the GMP approval. The products have obtained the Class II medical device license, which can assist companies in producing their own GMP medium or other cell culture components and obtaining the license.
• Specifications
  • The SFM can proliferate about 100 times of stem cells in 5 days and has a Class II medical material license.
  • The yield of MSCs is about 10,000 times higher than that of the serum-containing MSCs culture system.
  • This technology has had many successful cases in pet medical trials and has been recognized and respected by international journals.
  • The GMP Plant can accept contract manufacturing and assist companies in obtaining licenses quickly.

Applications & Benefits

• The medium can be used for the proliferation of MSCs from the umbilical cord, bone marrow, fat, placenta, and other sources. It can also be used as cryopreservation reagent.
• The unique MSCs mass production technology can be effectively used in the field of pet cell therapy or human cell therapy.
• The production factory, which has obtained GMP approval, can produce not only medium but also any other cell culture-related processing components.

One-Stop Biomedical Services

• Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
• Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
• Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
• Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
• Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.