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科技部新聞稿:科技部萌芽計畫--前瞻學術成果提升輸血與食安品質,100%學研單位自製,血液減白器獲美國FDA上市許可隨身裝置2分鐘可精準檢測食物過敏源

前瞻學術成果應用,協助提升國人輸血安全與食安品質

科技部於3月13日舉行記者會,會中發表兩項重大研發成果提升國人輸血安全與食安品質之應用。中原大學張雍教授團隊開發之血液減白器,為目前同類產品中具有最佳過濾效率及白血球減除率,且由國內完全自主開發生產,於107年底取得美國FDA上市許可,為萌芽團隊醫材商業化路程樹立重要里程碑。近年食品安全被重視,在科技部千里馬、萌芽等計畫持續協助下,中央大學黃貞翰助理教授從概念驗證到開發完成快速食品過敏源檢測套件,可解決市售產品無法及時且準確檢測過敏原含量之問題,兩分鐘內可獲得媲美中央實驗室等級結果。

科技部自100年起推動「研發成果萌芽計畫」歷經實驗性計畫、各項創業計畫之前導計畫等階段,計畫補助對象為研發成果商業化最早期階段之技術團隊。前瞻學研成果之商業化路程艱辛且需要時間,101年補助之張雍團隊歷經超過八年努力,終於獲得美國上市許可,107年補助之黃貞翰團隊也即將進入商業化,期待大家給予技術團隊更多且持續的支持。

 

白血球減除過濾器守護國人輸血安全!

輸血過程中,若將捐血者的白血球隨著血液進入受血者身體中,依受血者身體健康程度不同,會產生不同的副作用與併發症。全球已有超過20 個醫療先進國家通過輸血減除白血球法案,將白血球減除列為輸血必要程序,根據現階段歐美法規,血球過濾器需達 99.9%以上之白血球減除效果,才能達到輸血安全的標準。

科技部萌芽計畫輔導之中原大學薄膜技術研發中心張雍主任之薄膜技術衍生新創公司-「普瑞博生物科技股份有限公司」開發「抗凝血型白血球減除過濾器之系列產品」,使捐血中心與醫療院所僅需透過薄膜過濾裝置,即可提供醫護人員精準濾除人體血液中的白血球,不僅大幅提高輸血安全,同時也降低因輸血倂發症所產生的龐大醫療支出。

近年來我國也透過血液基金會積極推動台灣全面減白宣導,以保障國人輸血安全,全球目前每年使用量約6 千萬個,整體市場規模至少達每年300 億以上。此外,減白後血小板濃厚液,近年來臨床研究開始使用於傷口癒合、組織再生、關節炎治療與醫美等領域,未來濳力市場商機將超過100 億美元。

普瑞博生技於2016 年成立,同年完成種子輪募資並獲得國家生技醫療產業策進會「第13 屆國家新創獎」- 初創企業獎榮耀。產品完全由台灣學術單位自行研發生產,2017 年於新竹科學園區建構完成台灣第一個自動化減白過濾器製造廠,通過ISO 13485 認證,並於2018 年11 月取得美國FDA 510K紅血球減白過濾器產品上市許可證。

 

2分鐘確認食物有無過敏原,食安新利器開發完成!

大眾常有無從得知原因的身體不適徵狀發生?那就要小心可能已經開始有了過敏性的體質,其中由食物所引起的慢性過敏與急性過敏反應,有時甚至會付出生命的代價。在美國約有5000萬人患有嚴重的食物過敏反應,每年有20萬人因為食物過敏而急診治療,相關的醫療支出就需要 250 億美金,全球食物過敏的例子持續增加,特別是在孩童的比例更加明顯。

科技部千里馬計畫補助中央大學黃貞翰助理教授赴哈佛醫學院與麻省總醫院從事博士後研究,歸國後萌芽計畫接續協助實現「食安智聯網過敏原檢測裝置」之原型製作並組成台灣優勢感測團隊。關鍵技術之萃取與感測晶片過敏原套組及過敏原訊號讀取裝置易於攜帶,結合智慧型手機APP,使用者不需複雜訓練即可搭配個人智慧型手機進行現場量測,提供快速精確檢測食物過敏原的便利工具,2分鐘內即可得到實驗室儀器等級之高靈敏度測試結果。

目前已可針對市面食物中的六大過敏原進行檢測,如麩質、花生、牛奶、雞蛋等,未來更可擴大應用於其他食安相關檢測,如環境荷爾蒙、農藥、食物中毒之毒素及追蹤食品上游來源之核酸DNA鑑定等,讓過敏者安心食用,食品業或餐廳業者更可監測產品是否含過敏原、毒素等污染,確保銷售安全並建構產品安全履歷。

今年獲選為參加美國消費性電子CES展的團隊之一,以造成過敏的麩質為例,因其靈敏度遠高於美國法規,受到許多的關注與詢問,除了美國Great Mall、CVS外,日本Glico與澳洲等地的許多廠商亦表明希望合作推廣的意願。期望在不久的未來消費者都能為自己的食安進行把關,並以台灣為基地,推向國際更大的市場。

 

科技部建構更加友善的科技新創生態系

萌芽計畫開始補助團隊至今,台灣創業環境也同時進步,科技基本法修訂完成後,讓學術成果轉化更加務實與開放,各項科研成果創新與創業計畫也同時陸續啟動。科技部對於前瞻技術商業化之協助持續擴大,規劃設立的國際新創基地 Taiwan Tech Arena (TTA),邀請國際加速器進駐,共同建構更加友善的科技新創生態系,致力於打造台灣成為科技創新之島。

 

研究成果聯絡人

陳彥文總經理 普瑞博生技

電話:03-668-7199    Email:luke@puriblood.com

黃貞翰助理教授 國立中央大學 生醫工程與科學學系
電話:03-4227151轉27753    Email:chhuang@ncu.edu.tw

 

Prospectively Academic Achievements Improving Blood Transfusion and Food Safety

 

Prospective application of academic achievements to improve blood transfusion and food safety

The Ministry of Science and Technology (MOST) has held a press conference on March 13th, in which two major research and development results were published to enhance blood transfusion and food safety.

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.

 

Leukocyte reduction filter protects the blood transfusion safety of the people!!

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.

 

2-min accurate detection of food allergens, the cutting-edge solutions of food safety!!

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.

 

MOST builds a friendly technological innovation ecosystem

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.

 

 

Media Contact

Dr. Yan-Wen Chen

President

PuriBlood Medical Co., Ltd

+886-3-668-7199

luke@puriblood.com

 

Dr. Chen-Han Huang

Assistant Professor

Department of biomedical sciences and engineering, National Central University

+886-3-4227151 Ext.27753

chhuang@ncu.edu.tw

 

Yueh-Mei Lin

Assistant Researcher

Department of Academia-Industry Collaboration and Science Park Affairs, MOST

+886-2-2737-7240

ymlin@most.gov.tw

更新日期 : 2019/03/15