Orbit

紀 威光
兼任教師
職稱 教授級專業技術人員
姓名 紀 威光
聯絡電話 02-2695-6933 ext. 2250
電子郵件 weikchi@mail.dcb.org.tw
學歷 美國 賓夕法尼亞大學 化學工程 博士(1987)
研究專長 基因重組蛋白質藥物及單株抗體藥物:
1. 生技製程開發及製程放大
2. CGMP 生產及IND CMC
  • 美國 賓夕法尼亞大學 化學工程 博士(1987)
  • 美國 賓夕法尼亞大學 化學工程 碩士(1984)
  • 台灣大學 農業化學 農學士(1978)
財團法人生物技術開發中心 現職:
  • 副執行長(2008/12/1~迄今)
  • 特聘專家 (2009/9 ~迄今)
財團法人生物技術開發中心 經歷:
  • CGMP 生技藥品先導工廠廠長 (2001/1~2013/3)
  • 研發處長(2008/9/16~2008/11/30)
  • 正研究員 (2001~2009/8/31 )
  • 生技中心產程開發組研究員 (1994~2001)
  • 生技中心產程開發組副主任 (1991~2001)
  • 生技中心產程開發組副研究員 (1987~1994)
外部經歷
  • 衛福部TFDA 生物製劑相關法規編修委員/專家 (1991~迄今)
  • 台北醫學院生物醫學技術研究所兼任副教授 (1998/8~2003/7)
  • 衛生署血液製劑詢委員會委員 (1997~2001)
  • 衛生署預防醫學研究所兼任研究員 (1993~1999)
  • 中國文化大學生物科技研究所兼任副教授 (1990~1997)
  • 教育部副教授證書(副字第一五一三七號)(年資起算:1990 年2 月)
  1. 2013年4月將CGMP生技藥品先導工廠民營化,移轉專業團隊39人,生技中心取得現金及股權收入,由台康生技接手經營,並進行後續商業化生技藥品生產設施建立.
  2. 協助生技中心及生技藥品產業界生產臨床試驗用蛋白質藥品,並取得TFDA, US FDA, Canada FDA,及歐盟EMA核准進行臨床一期(5項)及二期試驗(2項),達到國際水準.
  3. 2013年4月將”生物相似性藥品技術開發”(國科會計畫編號10-2325-B-169-001-CC2)產學計畫研究成果授權台新藥公司,生技中心取得現金收入,台新藥將繼續進行開發,預計2019年可以上市.
  4. 2011年度獲頒經濟部法人科技專案「高品質臨床一/二期生技藥品試驗用藥委託製造及分析服務」- 「研發服務卓越獎」
  5. 2011年3月於新加坡BioPharma Asia Convention 2011代表DCB CGMP BPPF接受"Best CMO Award”.
  6. 2010年獲頒經濟部法人科技專案「藥物基磐運作三年計畫(1/3)-從基因到生技藥品GMP生產之加值領航者」- 「價值領航獎」
  7. 2009年度獲頒經濟部法人科技專案「藥物基磐建置及運作四年計畫」 - 「優良計畫主持人獎」
  8. CGMP生技藥品先導工廠規劃、建廠、確效及運作 (2000/3 – 2013/3)
(a) 建置Mammalian cell culture GMP facility (500 Liter及300 Liter bioreactor, purification system, LC/MS analytical characterization platform, QC/QA)
(b) 建置Microbial fermentation GMP facility (100 Liter及20 Liter fermentor, purification system)
(c) 衛生署GMP認証- 2005年12月
(d) US FDA DMF- 2006年3月
(e) 衛福部TFDA GMP認證 - 微生物醱酵生產線擴充2012年11月
  1. Shih-Yeh Lin, Yao-Chi Chung, Hsin-Yi Chiu, Wei-Kuang Chi, Bor-Luen Chiang, Yu-Chen Hu (2013, Oct). Evaluation of the stability of enterovirus 71 virus-like particle. Journal of Bioscience and Bioengineering.
  2. Yu-Li Lin, Chun-I Yu, Yu-Chen Hu, Tze-Jiun Tsai, Yin-Chieh Kuo, Wei-Kuang Chi, Ae-Ning Lin, Bor-Luen Chiang (2012, Feb). Enterovirus type 71 neutralizing antibodies in the serum of macaque monkeys immunized with EV71 virus-like particles.. Vaccine, 30 (7) 1305– 1312.
  3. Chung CY, Chen CY, Lin SY, Chung YC, Chiu HY, Chi WK, Lin YL, Chiang BL, Chen WJ, Hu YC. (2010, Oct). Enterovirus 71 virus-like particle vaccine: improvedproduction conditions for enhanced yield.. Vaccine, 8;28(43):6951-7.(SCI).
  4. Chiang CC, Lin YH, Lin SF, Lai CL, Liu C, Wei WY, Yang SC, Wang RW, Teng LW, Chuang SH, Chang JM, Yuan TT, Lee YS, Chen P, C (2010, Aug). Discovery of pyrrole-indoline-2-ones as Aurora kinase inhibitors with a different inhibition profile.. J Med Chem, 26;53(16):5929-41.. (SCI).
  5. Chen CS, Chiou CT, Chen GS, Chen SC, Hu CY, Chi WK, Chu YD, Hwang LH, Chen PJ, Chen DS, Liaw SH, Chern JW. (2009, May). Structure-based discovery of triphenylmethane derivatives as inhibitors of hepatitis C virus helicase. J Med Chem, 14;52(9):2716-23.. (SCI).
  6. 1. Chun-Yi Lu , Bor-Luen Chiang , Wei-Kuang Chi, Mei-Hwei Chang , Yen- Hsuan Ni , Hsu-Mei Hsu , Shiing-Jer Twu , Ih-Jen Su 4 Li- (2004, Dec). Waning immunity to plasma-derived hepatitis B vaccine and the need for boosters 15 years after neonatal vaccination. Hepatology, 40(6):1415-20. (SCI).
  7. Huang YH, Wu JC, Tao MH, Syu WJ, Hsu SC, Chi WK, Chang FY, Lee SD. (2000, Jul). DNA-Based immunization produces Th1 immune responses to hepatitis delta virus in a mouse model.. Hepatology. , 32(1):104-10. (SCI).
  8. J N Tsai, C H Lee, H Jeng, W K Chi, W C Chang (2000, Mar). Differential expression of glycogen synthase kinase 3 genes during zebrafish embryogenesis. Mechanisms of Development, 91(1-2):387-91.
  9. Ou-Yang P, Chiang BL, Hwang LH, Chen YG, Yang PM, Chi WK, Chen PJ, Chen DS (1999, Apr). Characterization of monoclonal antibodies against hepatitis C virus nonstructural protein 3: different antigenic determinants from human B cells. J Med Virol, 57(4):345-50.. (SCI).
  10. Huang LM, Chiang BL, Lee CY, Lee PI, Chi WK, Chang MH (1999, Mar). Long-term response to hepatitis B vaccination and response to booster in children born to mothers with hepatitis B e antigen. Hepatology., 29(3):954-9.(SCI).
  11. Dou HY, Wu JC, Peng WL, Chang C, Chi WK, Chu YD, Hu CP (1998, Dec). Analysis of T cell receptor Vbeta gene usage during the course of disease in patients with chronic hepatitis B. Journal of Biomedical Science, 5(6):428-34.
  12. Hsu CC, Hwang LH, Huang YW, Chi WK, Chu YD, Chen DS. (1998, Dec). An ELISA for RNA helicase activity: application as an assay of the NS3 helicase of hepatitis C virus.. Biochem Biophys Res Commun, 30;253(3):594-9. (SCI).13. Dou HY, Wu JC, Peng WL, Chang C, Chi WK, Chu YD, Hu CP. (1998, Nov).
  13. Analysis of T cell receptor Vbeta gene usage during the course of disease in patients with chronic hepatitis B.. J Biomed Sci, 5(6):428-34. (SCI).
  14. Chiang BL, Yang PM, Hwang LH, Wang JM, Kao SF, Pan CH, Chi WK, Chen PJ, Chen DS (1998, Aug). Establishment and characterization of NS3 proteinspecific T-cell clones from a patient with chronic hepatitis C. Journal of Biomecical Science, 5(4):290-6.
  15. Chow YH, Chiang BL, Lee YL, Chi WK, Lin WC, Chen YT, Tao MH (1998, Feb). Development of Th1 and Th2 populations and the nature of immune responses to hepatitis B virus DNA vaccines can be modulated by codelivery of various cytokine genes. The Journal of Immunology, 160(3):1320-1329.
  16. Wu HL, Chen PJ, Mu JJ, Chi WK, Kao TL, Hwang LH, Chen DS. (1997, Sep). Assembly of hepatitis delta virus-like empty particles in yeast. Virology, 236(2):374-81.
  17. Chow YH, Huang WL, Chi WK, Chu YD, Tao MH (1997, Jan). Improvement of hepatitis B virus DNA vaccines by plasmids coexpressing hepatitis B surface antigen and interleukin-2. Journal of Virology, 71(1):169-78.
  18. Hsu HY, Chang MH, Hsieh RP, Ni YH, Chi WK (1996, Dec). Humoral and cellular immune responses to hepatitis B vaccination in hepatitis B surface antigen-carrier children who cleared serum-hepatitis B surface antigen. Hepatology, 24(6):1355-60.
  19. Tai CL, Chi WK, Chen DS, Hwang LH. (1996, Dec). The helicase activity associated with hepatitis C virus nonstructural protein 3 (NS3).. Journal of Virology, 70(12):8477-84.
  20. Hwang LH, Yang PM, Lai MY, Chiang BL, Kao JH, Wang JT, Lee SY, Chian HM, Chi WK, Chu YD, Chen PJ, Chen DS (1996, Jul). Identification of humoral antigenic determinants in the hepatitis C virus NS3 protein. The Journal of Infectious Diseases, 174(1):173-6.
  21. Yang PM, Hwang LH, Lai MY, Huang WL, Chu YD, Chi WK, Chiang BL, Kao JH, Chen PJ, Chen DS (1995, Aug). Prominent proliferative response of peripheral blood mononuclear cells to a recombinant non-structural (NS3) protein of hepatitis C virus in patients with chronic hepatitis C. Clinical and Experimental mmunology, 101(2):272-.
  22. W K Chi, C H Ku, C C Chang, J N Tsai (1994, Jun). Two-step cell disruption for the extraction of membrane-associated recombinant protein from Saccharomyces cerevisiae. Annals of the New York Academy of Sciences, 721:365-73. 本人為第一作者、通訊作者.
  23. Wei Kuang Chi, Daniel D. Perlmutter ‐ (1989, Nov). The effect of pore structure on the char‐steam reaction. AIChE Journal, 35(11):1791 - 1802. 本人為第一作者、通訊作者.