傅煦媛Hsu-Yuan Fu

關於我 / About

傅煦媛

研究者，目前從事 GMI（小孢子靈芝免疫調節蛋白）的研發工作。取得博士學位並完成博士後研究後回到臺灣，十餘年間歷經不同的專業領域與職務轉換。這個網站是我把工作上讀到的科學研究，轉譯成健康與科研議題的個人筆記。

Hsu-Yuan Fu

Researcher working on GMI (Ganoderma microsporum immunomodulatory protein) R&D. After a PhD and postdoctoral research abroad, I returned to Taiwan, where my career has crossed several professional fields over the past decade and more. This site is where I translate the science I read at work into personal notes on health and research topics.

GMI：從學術研發到產業化 / From bench to registered ingredient

GMI 是以 Pichia pastoris 生產的重組真菌免疫調節蛋白。這些里程碑都是公開登錄或已發表的資料，也是我這十年工作的主軸。
GMI is a recombinant fungal immunomodulatory protein expressed in Pichia pastoris. Every milestone below is on the public record.

  1. 食品 Food
    全球第一件重組蛋白食品原料
    World's first recombinant protein approved as a food ingredient

    美國 FDA 新膳食成分（NDI）通知；臺灣 TFDA 非傳統性食品原料核准。

    U.S. FDA New Dietary Ingredient (NDI) notification; Taiwan FDA non-traditional food ingredient approval.

  2. 化粧品 Cosmetics
    四個法域、七件化粧品原料登錄
    Seven cosmetic-ingredient registrations across four jurisdictions

    PCPC INCI（美國）2 件、JCIA INCI（日本）2 件、臺灣 TFDA 2 件、歐盟 CosIng 1 件。

    PCPC INCI ×2, JCIA INCI ×2, Taiwan FDA ×2, EU CosIng ×1.

  3. 安全性 Safety
    GLP 安全性評估論文
    GLP safety assessment published

    基因毒性、13 週大鼠口服毒性、胚胎－胎兒發育毒性（Toxicology Reports, 2022）。

    Genetic toxicology, 13-week oral gavage and embryo-fetal developmental toxicity in SD rats (Toxicology Reports, 2022).

  4. 藥品 Pharma
    GMP 原料藥與美國 FDA DMF
    GMP drug substance and U.S. FDA Drug Master File

    2025 年 4 月首批 GMP 原料藥批次放行；2025 年 10 月 FDA 受理 DMF，合作夥伴可於自身申請案中引用。

    First GMP drug-substance batch released Apr 2025; DMF acknowledged by FDA Oct 2025, cross-referenceable by partners.

經歷 / Timeline

學術與研究、產業與法規兩條軌道共用同一條時間軸（寬螢幕時分列左右）。每一站都可展開英文。
Academic and industry tracks on one shared axis (side by side on wide screens). Expand each entry for English.

  1. 2023 – 現在 · 2023 – present

    科學長（兼任）

    GMI 原料研發公司（臺北）｜再生醫學子公司

    把 GMI 從食品與化粧品原料，往細胞治療與再生醫學推進：以「培養基添加物」的角色，改善間質基質細胞、免疫細胞與多能幹細胞衍生產品的擴增與品質。

    • GMI 原料藥技術移轉至 CDMO：2024 年 4 月啟動，2025 年 4 月首批 GMP 批次放行（約 12 個月）
    • 撰寫並提交美國 FDA 藥物主檔案（DMF），2025 年 10 月獲受理；Pre-IND／IND 準備中
    • 主持與臺灣細胞治療機構的共同開發案，評估 GMI 作為 MSC 擴增與免疫細胞製造的培養基添加物
    English
    Chief Scientific Officer (concurrent) — GMI ingredient developer, Taipei — regenerative medicine subsidiary

    Directing the translation of GMI from food/cosmetic ingredient into cell therapy and regenerative medicine — as a defined, animal-component-free culture-media supplement for MSC, immune-cell and PSC-derived products.

    • Tech transfer of GMI drug substance to a CDMO: kickoff Apr 2024, first GMP batch released Apr 2025 (~12 months).
    • Authored and filed the U.S. FDA Drug Master File for GMI drug substance; acknowledged Oct 2025. Pre-IND / IND in preparation.
    • PI of a co-development program with a Taiwan cell-therapy clinic evaluating GMI as a media supplement for MSC expansion and immune-cell manufacturing.
  2. 2016 – 現在 · 2016 – present

    研發經理（2016）→ 研發資深經理（2017）→ 科學長（2020 –）

    GMI 原料研發公司（臺北）

    建立並營運 Pichia 分泌型重組蛋白的 GMP／ISO 先導工廠；交出全球第一件以重組蛋白作為食品原料的上市許可（美國與臺灣）。

    • 負責從候選物篩選、轉譯研究、GLP 非臨床毒理、人體試驗到法規申請的完整開發鏈；管理 CDMO／CRO、技轉與授權
    • 完成 10+ 件機能性原料委託研究或產業化案：2 件人體臨床、7 件 GLP 動物毒理、3 件上市產品
    • 研發團隊由 5 人擴編至 12 人，四年零離職；培養先導工廠負責人、實驗室主管、QC 與 QA 主管
    • 經濟部生技新藥公司計畫共同主持人（2016–2017）、主持人（2018 –）；SBIR Phase II 計畫主持人（2017）
    English
    R&D Manager (2016) → R&D Senior Manager (2017) → Chief Scientific Officer (2020 –) — GMI ingredient developer, Taipei

    Built and operate a GMP/ISO pilot plant for secreted recombinant proteins in Pichia; delivered the world's first recombinant protein approved as a food ingredient (U.S. and Taiwan).

    • Own the full chain from candidate selection through translational research, GLP toxicology, human studies and regulatory filing; manage CDMO/CRO partners, tech transfer and licensing.
    • 10+ commissioned or industrialization programs for functional ingredients: 2 human clinical studies, 7 GLP animal toxicology studies, 3 marketed products.
    • Grew R&D from 5 to 12 with no turnover over four years; developed the pilot-plant lead, lab manager and heads of QC/QA.
    • Co-PI (2016–17) then PI (2018–) on Ministry of Economic Affairs biotech programs; PI of an SBIR Phase II program (2017).
  3. 2015 – 2016

    研究員，生物工程組

    財團法人生物技術開發中心（DCB）生物製藥研究所

    把明尼蘇達大學 CHO Consortium 的五種細胞株開發策略與 NGS 遺傳穩定性評估方法導入臺灣；建立從 DNA 到純化蛋白的一站式 CDMO 能力（團隊 13–15 人）。

    English
    Research Fellow, Bioengineering Group — Development Center for Biotechnology (DCB), Institute of Biologics

    Led transfer of five CHO cell-line development strategies and NGS-based genetic-stability methods from the University of Minnesota CHO Consortium; built one-stop CDMO capability from DNA to purified protein (team of 13–15).

  4. 2014 – 2015

    博士後研究員

    美國明尼蘇達大學 化學工程與材料科學系（胡維修教授實驗室）

    建立全球第一批中國倉鼠胚胎纖維母細胞來源的誘導性多能幹細胞（iPSC）並完成特性分析（Stem Cell Research, 2017）；開發兩種 NGS 方法評估生產細胞株的遺傳與克隆穩定性。

    • CHO Consortium 技術專案負責人：統籌約 20 位碩博士級人員，服務 6 家全球藥廠會員；參與中國倉鼠基因體計畫的生物資訊分析
    English
    Postdoctoral Associate — University of Minnesota, Chemical Engineering & Materials Science (Prof. Wei-Shou Hu)

    Generated and characterized the first iPSC lines from Chinese hamster embryonic fibroblasts (Stem Cell Research, 2017); developed two NGS-based methods for genetic and clonal stability of production cell lines.

    • Technical project lead for the CHO Consortium (~20 M.S./Ph.D. staff, six global biopharma members); bioinformatics support to the Chinese hamster genome project.
  5. 2013 – 2014

    博士後研究員

    臺灣大學 慶齡工業研究中心

    將博士論文的蛋白質量產平台產業化：發明新型膜蛋白表現載體並完成專利說明書（U.S. Patent 9,067,985 B2），完成一件技術移轉。

    English
    Postdoctoral Associate — Yen Tjing Ling Industrial Research Institute, National Taiwan University

    Industrialized the PhD protein-production platform: invented a membrane-protein expression vector (U.S. Patent 9,067,985 B2) and completed one technology transfer.

  6. 2008 – 2013

    博士

    臺灣大學 生化科技學系暨研究所

    研究嗜鹽古菌的多重視紫質（rhodopsin）系統與膜蛋白表現（Journal of Bacteriology 2010、Molecular Microbiology 2013）；2010 年獲國科會補助赴日本理化學研究所（RIKEN）進行膜蛋白表現與結晶技術交流。

    • 臺灣生物物理學會年會口頭／壁報獎四次（2008、2011、2012、2013）；國際視網膜蛋白會議（ICRP）口頭與壁報發表（2010 加州、2012 蘇黎世）
    English
    Ph.D. — National Taiwan University, Biochemical Science and Technology

    Multi-rhodopsin systems and membrane-protein expression in halophilic archaea (J. Bacteriology 2010; Molecular Microbiology 2013); national grant for a technical exchange on membrane-protein expression and crystallography at RIKEN Harima, Japan (2010).

    • Four oral/poster awards at the Taiwan Biophysics Conference (2008, 2011–13); presentations at the 14th and 15th International Conference on Retinal Proteins (2010, 2012).
  7. 2002 – 2008

    學士 生化科技學系（2002–2006）→ 碩士 微生物與生化學研究所（2006–2008）

    臺灣大學

    2008 年獲選中華民國斐陶斐榮譽學會榮譽會員。

    English
    B.S. Biochemical Science and Technology (2002–06) → M.S. Microbiology and Biochemistry (2006–08) — National Taiwan University

    Honorary Member, Phi Tau Phi Scholastic Honor Society (2008).

專業認證 / Certifications

專利 / Patents

  1. 含靈芝免疫調節蛋白之外泌體組成物及其用途GMI
    Exosome composition containing Ganoderma immunomodulatory protein and uses thereof
    Hseu, R.-S., Fu, H.-Y. — 臺灣核准（2026）；美國、中國、歐洲、日本審查中 · Granted: Taiwan (2026). Pending: US, CN, EU, JP.
  2. 促進與治療慢性傷口癒合之組成物及方法GMI
    Composition and methods for promoting and treating chronic wound healing
    Fu, H.-Y., Cheng, Y.-C. — 美國（2021）、臺灣（2022）、中國（2024）核准 · Granted: US (2021), Taiwan (2022), China (2024).
  3. 細菌視紫質融合膜蛋白表現系統
    Bacteriorhodopsin fusion membrane protein expression system
    Fu, H.-Y. et al. — 美國專利 9,067,985 B2（2015） · U.S. Patent 9,067,985 B2 (2015).

論文與教學 / Publications & Teaching

精選論文（共 22 篇同儕審查論文；* 為共同第一作者） · Selected publications
  1. Fu, H.-Y., Hseu, R.-S. (2022) Safety assessment of the fungal immunomodulatory protein from Ganoderma microsporum (GMI) derived from engineered Pichia pastoris: genetic toxicology, a 13-week oral gavage toxicity study, and an embryo-fetal developmental toxicity study in Sprague-Dawley rats. Toxicology Reports 9:1240–1254.
  2. Lim, G.Z., Lin, Y.-E., Chen, P.-C., Fu, H.-Y., Yang, C.-S. (2026) Cryo-EM structure of the SRI-HtrI complex reveals the cytoplasmic coupling in an archaeal phototaxis system. Nature Communications.
  3. Pei, H., Fu, H.-Y.*, Hirai, H., et al., Hu, W.-S. (2017) Generation of induced pluripotent stem cells from Chinese hamster embryonic fibroblasts. Stem Cell Research 21:132–136.
  4. Zhao, L., Fu, H.-Y.*, Raju, R., Vishwanathan, N., Hu, W.-S. (2017) Unveiling gene-trait relationship by cross-platform meta-analysis on Chinese hamster ovary cell transcriptome. Biotechnology and Bioengineering 114:1583–1592.
  5. Hsu, M.-F., Fu, H.-Y.*, Cai, C.-J., Yi, H.-P., Yang, C.-S., Wang, A.H.-J. (2015) Structural and functional studies of a newly grouped Haloquadratum walsbyi bacteriorhodopsin reveal the acid-resistant light-driven proton pumping activity. Journal of Biological Chemistry 290:29567–29577.
  6. Fu, H.-Y., Yi, H.-P., Lu, Y.-H., Yang, C.-S. (2013) Insight into a single halobacterium using a dual-bacteriorhodopsin system with different functionally optimized pH ranges. Molecular Microbiology 88:551–561.
  7. Fu, H.-Y., Lin, Y.-C., Chang, Y.-N., et al., Ng, W.V., Yang, C.-S. (2010) A novel six-rhodopsin system in a single archaeon. Journal of Bacteriology 192:5866–5873.