基亞生 布局由疫苗到生物相似藥 (攜手MABXIENCE)

基亞生與瑞士藥廠合作 進軍生物相似藥領域 2016-02-1510:00 〔記者陳永吉／台北報導〕基亞生（6547）今早公告，已於2月8日與瑞士MABXIENCE公司簽訂合作備忘錄，擬參與生物相似藥（Biosimilar）國際合作案，共同開發具市場潛力之生物製劑藥品。雙方後續將另行簽訂正式合約，並依相關法令規定程序辦理。未來基亞生將可取得亞洲主要國家之獨家商業權利，並獲得生物相似藥之生產技術移轉。基亞生表示，此次合作案將可提升公司的全球知名度，並於原有細胞培養疫苗業務外增加生物相似性藥品開發，強化公司技術生產能量，在生物製劑領域佈局更為完整。基亞生表示，MABXIENCE公司2009年成立於歐洲，為歐洲醫藥集團CHEMO全資子公司，主要負責該集團生物製劑業務，擁有歐盟認證之GMP製造廠房，目前有多項生物相似性藥品開發中。MABXIENCE母公司CHEMO成立於1977年，為總部位於西班牙馬德里的歐洲醫藥集團，營業項目包含活性藥物和成品劑型製造、品牌藥與生物技術三個領域，年營收超過10億歐元，全球共有5000多名員工，40個國家有據點。

mAbxience is the first plant in Europe to implement Single-Use technology in most of its processes, from cell bank thawing to purification and formulation of the final product. It is also used in the cultivation process and the preparation of all the necessary media and solutions. The incorporation of Single-Use bioreactors is one the greatest innovations in the industry and provides a double advantage. On one hand, it provides greater flexibility, allowing products to be changed in record time. On the other hand, it eliminates any possibility of cross contamination throughout this process. Furthermore, this technology allows for significant savings in resources used during the production process. It mainly curtails the consumption of water and cleaning agents, lowering their use by 80% and 90% respectively since they are not needed to clean the reactors. This allows the environmental impact of our facilities to be reduced.

Facilities The León plant is one of the main biopharmaceutical development plants in Europe, with fully integrated Single-Use technology. Its facilities cover a surface area of 5,500 square metres, which is distributed as follows:• R&D laboratories: 200 m2• Quality Control laboratories: 250 m2• GMP pilot plant (200 l): 250 m2• Future GMP industrial plant (2,000 l): 4,800 m2. The future industrial plant has a 2,600 m2 production area, a 1,000 m2 warehouse and a 1,200 m2 service area.