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The U.S. FDA 510K licensed anticoagulant leukocyte depletion filter is developed by research team of Professor Yung Chang from Chung Yuan Christian University. The technology is completely developed & produced in Taiwan, which has the best filtration efficiency and white blood cell (WBCs) depletion rate for similar products. It is an important milestone for the commercialization of the medical device in MOST Germination Program.
Food safety has been gradually an emphasis in recent years. Under the continuous assistance of the MOST Germination Program, Assistant Professor Chen-Han Huang from the National Central University has completed the concept verification to develop a rapid food allergy detection kit. It provides the solution that which the commercial product cannot detect in time and accurately. Moreover the results can be acquired within two minutes; and the results could be comparable to Central Laboratory. .
Since 2011, MOST has promoted the "Germination Program”, which had experienced several phases, such as in experimental research, pilot program to various in entrepreneur plan and so on. The program is targeted at the technical team in the earliest stage of commercialization of R&D results. Prospectively academic achievements commercialize will be overcome any obstacle for the duration.
The team of Professor Yung Chang’s has been subsidized in 2012. After eight years of dedication, the team finally obtained the U.S. marketing authorization in 2018. As for the team of Assistant Professor Chen-Han Huang’s, it is subsidized in 2018, and will soon enter commercialization as well. It is highly appreciated for more support for technical teams.
Different side effects may occur in the process of blood transfusion if the allogeneic WBCs from the blood donor to the recipient. Transfusion-induced complications are depending on the health of the recipient. More than 20 countries in the world have passed the Universal Leukoreduction (ULR) Act, which specified leukocytes reduction as a necessary procedure for blood transfusion. According to current European and American regulations, the leukocyte reduction filter needs more than 99.9% WBCs subtraction, in order to achieve the standard safety of blood transfusion.
MOST Germination Program counsels a derivative startup company, "PuriBlood Biotechnology Co., Ltd.", from Director Yung Chang of R&D Center for Membrane Technology at Chung Yuan Christian University, to develop "a series of product sets for anticoagulant leukocyte depletion filter". With this new technology, blood donation centers and medical institutions only need to use a membrane filtration device to provide medical personnel with accurate filtering of more than 99.9% of white blood cells in human blood, which not only greatly improves blood transfusion safety, but also reduces the huge medical expenses caused by transfusion complications.
Taiwan has actively promoted ULR through the Taiwan Blood Foundation to ensure the safety of blood transfusion in recent years. The current use of leukocyte reduction filter is about 60 million per year worldwide, and the overall market size is at least 1 billion per year. In addition, platelets concentrate with leukocyte reduction has begun to be used in wound healing, tissue regeneration, arthritis treatment and medical beauty in recent years. The business opportunities in the global market is expected to exceed 10 billion U.S. dollars in the future.
PuriBlood Medical CO., LTD. was founded in 2016 and had completed the seed fundraising in the same year. PuriBlood received the "13th National Innovation Award" of the National Biotechnology and Medical Industry Policy Association - Glory of the New Start-up Enterprise Award. The products are completely developed and produced by academic institution in Taiwan. In 2017, PuriBlood group set up the first automated manufacturing line to produce leukocyte reduction filters at Hsinchu Science Park in Taiwan, which is integrated from design and combination of multi-layer membrane assemble process and melting-cut packaging program. PuriBlood obtained the US FDA 510K license based on the ISO 13485 in November 2018.
You may have an allergic constitution if you often feel discomfort without knowing any reason. Chronic or acute allergic reactions caused by food sometimes could cause severe anaphylaxis to death. About 50 million people suffer from severe food allergies in the United States. There are around 200 thousand people being sent to emergency room for food allergy every year, and relevant medical cost is about 25 billion U.S. dollars. The global food allergy cases continue to increase, especially in children.
MOST Graduate Students Study Abroad Program support the post-doctoral research of Assistant Professor Chen-Han Huang from National Central University to Harvard Medical School and Massachusetts General Hospital. After returning Taiwan, the MOST Germination Program continued to assist in the prototype production of the “Integrated Magneto-Chemical Sensor For On-Site Food Allergen Detection” and formed Taiwan User-Friendly Sensor & Tech Co., Ltd.
The core technologies integrated by extraction, sensing kit and allergen signal reader are connected to smart phone APP to provide an easy-to-carry and convenient tool for quickly and accurately detecting food allergens. People without professional training can use the personal smart phone for on-site measurement, and the high sensitivity test results of laboratory instrument level can be obtained within 2 minutes.
At present, it can detect six major allergens in the market, such as gluten, peanuts, milk, eggs, etc.; and it will be extended to other tests in the future, such as environmental hormones, pesticides, food poisoning toxins and DNA identification tracking from upstream food sources in order to enable allergic patients to eat with peace of mind. Food industry or restaurant owners can monitor whether products contain allergens, toxins and other pollution, and ensure sales safety and build a safety product trace ability.
This year, the team was selected to attend the CES exhibition to exposure and advertise products. Because its gluten sensitivity is much higher than U.S. regulations, it was very popular during the exhibition. There are many companies, for example Great Mall and CVS in the U.S., Glico in Japan, and Australia also expressed their willingness for further cooperation. It is expected that the company will start from Taiwan, and to enter the international market to enable consumers to take care of food safety on their own.
Since the Germination Program began to subsidize until today, and the entrepreneurial environment in Taiwan has improved. Also after amendment of the Science and Technology Basic Law, academic achievements are more pragmatic and open. MOST has continuously assisted commercialization of prospective technology, and built up international startup hub, Taiwan Tech Arena (TTA), that invites international accelerators march into TTA. We are building a more friendly technology innovation ecosystem and are committed to turn Taiwan into an island of technology innovation.
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