Industrial Technology Research Institute

Technology Overview

Culture medium accounts for about 40% to 60% of cell R&D and manufacturing costs. However, there is a lack of key R&D capability invested in researching culture media in the domestic market; therefore, we have relied on foreign imports for a long time.

ITRI has developed a high-efficiency serum-free culture medium that contains no animal-derived components, eliminating the risk of zoonotic disease transmission. This enables the advancement of Mesenchymal Stem Cell (MSC) Mass Production Technology. This technology can rapidly multiply the number of stem cells to 100 times the original amount within just 5 days, and after 21 days of cultivation, stem cell levels can exceed 10,000 times the amount of stem cells produced by serum based media. It shortens the total processing time by 15 days and provides better stem cell characterization. Additionally, the production facility has obtained Taiwan's first Class II Medical Device GMP certification.

This technology has been successfully applied in human stem cell therapy research and veterinary medicine, enabling paralyzed pets to regain mobility. It can also be used for proliferation of mesenchymal stem cells from umbilical cords, bone marrow, fat, and placenta, as well as stem cell cryopreservation. This technology can be used as a foundation for manufacturing biotech products such as protein drugs, viral and nucleic acid vaccines, and gene therapy. This initiative will fill the gap in Taiwan's cell therapy industry and enhance the development and clinical capabilities for related products.

• 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.

Contact

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