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工業技術研究院

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技術名稱: 活體抗腫瘤藥物新藥開發技術

技術簡介

本技術可應用於評估具抗腫瘤活性的小分子、蛋白質藥物以及植物新藥的活體動物藥效作用的開發平台。透過腫瘤細胞株的異種皮下腫瘤動物疾病模式,可以快速的篩選出具有開發潛力的候選藥物。透過本平台針對動物模式的生理及病理的完整觀察,可以同時瞭解候選藥物在抗腫瘤的藥效評估、藥理作用機制以及潛在性的毒性反應觀察。利用腫瘤組織的H&E染色與組織免疫染色的分析,可以瞭解候選藥物的藥理學作用機制。藉由血清生化與主要臟器的切片染色,可同步評估候選藥物是否具有特定器官的毒性作用。目前本技術平台已建立的動物模式,包括有人類血癌細胞株 (MV4-11, RS4-11, MOLM-13)、人類肺癌細胞株 (NCI-H460, A549)、人類大腸癌細胞株 (COLO 205)、人類鼻咽癌細胞株(RPMI2650)、人類胰臟癌細胞株 (AsPC1, MIA-PaCa 2)、人類甲狀腺癌細胞株 (TT) 以及人類肝癌細胞株 (Hep G2, Huh-7, Hep 3B, SK-Hep1, PLC/PRF/5) 等腫瘤疾病動物模式,可評估候選藥物在藥效、藥動以及毒理之作用特性。

Abstract

These established platforms can supply the evidence to demonstrate the anti-tumor growth efficacy of small molecules, protein drugs and botanical drugs for pharmacodynamics effect in vivo. These platforms can simultaneously evaluate the anti-tumor growth effect, pharmacological mechanisms and pre-clinical toxicology evaluation through the physiological and pathological observations. These technological platforms include: 1) Tumor size measuring for subcutaneous xeongraft tumors in immunodeficiency (SCID or BALB/c nude) mice. 2) Hematoxylin and Eosin (H&E) staining and immunohistochemistry (IHC) staining of tumor tissue for mechanism study. 3) Biochemical analysis of serum and H&E staining of major organs (such as: heart, liver, spleen, lung, and kidney) for toxicity assessment. Nowadays, we had established different types of tumor animal models include: human acute myeloid leukemia (MV4-11, RS4-11and MOLM-13), human lung cancer (NCI-H460 and A549), human colon cancer (COLO 205)、human nasal carcinoma (RPMI2650)、human pancreatic carcinoma (AsPC1 and MIA-PaCa 2)、human thyroid carcinoma (TT) and human hepatocellular carcinoma (Hep G2, Huh-7, Hep 3B, SK-Hep1, PLC/PRF/5).

技術規格

本技術平台所使用的細胞株均為購自美國ATCC、台灣BCRC所認證的腫瘤細胞株。評估項目包含:1)監測腫瘤大小、體重變化以及生理和行為上的特殊改變。2)腫瘤組織染色,包含:H&E染色以及組織免疫染色,例如Ki67(細胞增生指標)、Caspase-3(細胞凋亡指標)及CD31(血管新生指標)或其他特殊分子標記。3)評估候選藥物的對重要臟器的毒性(H&E染色)以及肝腎毒性(血清生化分析包含:AST、ALT以及creatinine )。

Technical Specification

All of cancer cell lines in these platforms were purchased from the American Type Culture Collection (Manassas, VA, USA) or Bioresource Collection and Research Centre (Hsinchu, Taiwan). The assessment items include: 1) Tumor volume measuring, change of body weight and special physiological and behavioral changes. 2) H&E staining and IHC staining (Ki67 for cell proliferation, cleaved caspase 3 for apoptosis and CD31 for angiogenesis) of tumor tissues. 3) Toxicity evaluation of candidates by H&E staining of major organs, liver function (AST and ALT) and kidney function (creatinine)

技術特色

在藥物開發過程中,候選藥物能否成為試驗中新藥(investigational new drug; IND),活體動物藥效的評估是扮演最重要的評估指標。本技術平台除了能夠提供候選藥物在疾病動物模式下,評估是否達到治療程度的藥效作用外,還能夠同時評估候選藥物的藥物動力學參數,以及發掘可能的潛在毒性,對於決定候選藥物是否進入臨床試驗,可以提供完整的評估分析與建議。

應用範圍

1. 新抗腫瘤藥物的開發。 2. 藥物毒性評估 3. 藥物作用機制(標靶)的探討 4. 癌症治療之合併療法的組合與開發 5. 發展減緩化療副作用之健康食品或保健食品

接受技術者具備基礎建議(設備)

SPF環境之小鼠飼養場所、生化與分生實驗室、細胞培養室、酵素免疫分析儀。

接受技術者具備基礎建議(專業)

需具備動物實驗操作經驗、細胞培養、分子生物學、生物化學以及藥物開發之相關知識。具獸醫相關病理組織判讀之專業經驗尤佳。

技術分類 分子診斷

聯絡資訊

聯絡人:劉志鵬 標靶藥物技術中心

電話:+886-3-5732620 或 Email:cpliu@itri.org.tw

客服專線:+886-800-45-8899

傳真:+886-3-5732359

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