2024 年 07 月 29 日

再生醫療雙法通過,不只抗癌患者出現一線曙光,在美容保養領域,不時能看到關鍵字「外泌體」,未來要如何運用,也成為業界矚目焦點。對此,亞家生技具有獨家量產製程,除了協助醫療院所和生技業者,建造微型智能細胞製劑廠,再搭配自行開發的製藥級無菌充填、凍乾設備,從細胞培養平台、自動化無菌充填到產出「凍乾劑型」產品,製造過程一路把關品質,更能有效降低碳足跡,實行環保永續。

亞家生技創辦人吳坤烈博士表示,目前外泌體製成之生物製劑,多為凍液型式,「必須放置在攝氏零下80度的環境下保存,且期限也只有4個月,否則外泌體囊泡會破裂、失去活性。」但亞家的獨家製程不同,透過細胞製藥用無菌隔離裝置,搭配自行研發的充填凍乾設備,可做成「無菌凍乾製劑」,不只在室溫下可保存一年,回溶成液體也保有90%以上活性。另外,再加上外泌體鑑定分析等技術平台,以超越業界的嚴格標準,把關品質。

外泌體(Exosome)是一種微小的細胞外囊泡,直徑約30至150納米,內含各種生物活性分子,包括蛋白質、核酸(如DNA和RNA)、醣類和脂質。它們會在細胞之間傳遞訊息和調控信號,例如間質幹細胞分泌的外泌體,可調控受體細胞的生理和代謝過程,進而影響目標細胞的功能,像是調節免疫反應、促進細胞生長和分化、協調組織修復和再生等效果。

亞家生技為台灣首家研發「細胞製藥用無菌隔離裝置」。

由於再生醫療正值發展階段,如何降低製劑成本成為考驗。對比傳統實驗室的半開放式製程,內部環境管控難度高,亞家研發的「微型智能細胞製劑廠」,僅需傳統工廠66%空間,能大幅降低80%包括用電在內的維護營運成本,並透過無菌隔離裝置,維持藥品GMP規範中最高的Class A潔淨等級水準,將製程與就診端拉近,縮短製劑的運送時間、提高整體供應鏈效率。「如果再搭配亞家開發的充填設備,共60坪的空間,一個月就能產出約3萬瓶無菌凍乾製劑。」吳坤烈博士詳細計算出產能。凍乾製劑不只方便保存,還能減少碳足跡生成,整個製程更加環保永續。

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