2020-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/652200摘要：對於生技產業而言，無論是發展類新藥、全新化合物新藥或生物藥品 (biologics)，藥物劑型與 傳輸技術平台的發展，都扮演著關鍵性的角色。對於學界或一些新創的生技製藥公司，在臨床前試驗 階段缺乏完整且有系統的新產品製劑開發與驗證流程，再加上欠缺足夠兼具專業實務和跨領域的優秀 人才，導致學界或生技業者要將標的物有效加值至國際製藥公司願意接手，來橋接後續商業化的培育 機制，達成技術商品化的目標出現困難。 為提高學界在轉譯研究上的能量、銜接國內外生技業的發展需求以及培育具橋接能力的高階生技製藥 研發人才，本計畫在「由產品技術發展來培育人才，由人才培育來發展新技術平台」的原則下，藉由 合作廠商本身所擁有或技轉自本實驗室之標的物製劑開發，透過合作開發計畫執行的實務發展，來進 行醫藥製劑高階生技人才的培育和具高市場價值的產品開發。 本年度計畫中我們除了原先雙效微脂體的合作開發與承接的兩個委託案並發展出兩個具市場價值的產 品(JM17口服製劑及ASC-J9 Cream製劑)外，也發展出「抗生素增效乳化系統」與「特殊脂質載體技術 平台」這兩個藥物製劑平台。因此這一個年度計畫中除了人才培育和接受委託進行產品加值的發展目 標外，也開始建構出具有與先導性製造能力的先導性實驗室，為將來學界及業界發展中標的物進行加 值與商品化服務的最終目標奠定良好的發展基礎。<br> Abstract: Pharmaceutical formulations and delivery systems play important roles in developing generic drugs, new chemical entity and biologics. For academia or some newly established biotech or pharmaceutical companies, there is a lack of complete and systematic formulation development and validation process in the preclinical stage. Meanwhile, the lack of qualified personnel with experiences in formulation development and cross-cutting talents also handle the pharmaceutical product development, especially in its value-added to the level that the international pharmaceutical companies is willing to take over and further bridge the cultivation mechanism for its commercialization. In this proposal, we will focus in two directions to increase the capacity of translational research in the academic and industrial community. These two directions will be “development of formulation and pilot process” and “pharmacodynamics and pharmacokinetics studies in preclinical stage”. With these two approaches, we shall be able to meet the development needs of biotech industries in the preclinical stage and to cultivate high-level biotechnology research and development talents with bridging capabilities. To this purpose, in addition to our laboratory pipeline, we will cooperate with three industrial partners with their own product pipeline or tech-transferred from our laboratory. Two products, oral dosage form for JM17 & Cream formulation for ASC-J9, have been developed under the contract development. The ultimate goal of this project is not only the cultivation of talents through the project implementations but also the construction of a pilot laboratory with the ability to undertake commissioned R and D and contract development and manufacture.生技製藥藥物劑型研發委託服務PharmaceuticFormulationContract development and manufacture