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台灣醫療科技展 博訊生技展示獨家3A﹒GTP技術台廠唯一具量化和標準化細胞製程能力

細胞治療與再生醫學已是當前醫療產業最具發展潛力的新技術,隨著科學技術累積與突破,將具有活性的細胞、或透過基因改造的免疫細胞,當作藥物治療難治的疾病,或讓功能失調與受損的組織得以修復,如此的醫療效益讓再生醫學與細胞治療進而成為21世紀醫學的新治療方式,成為最受矚目的熠熠新星;然而幹細胞製造與產能不足,則成為細胞治療發展當前最大的隱憂。

利用先進智慧自動化細胞製程 加速幹細胞治療發展與應用

細胞治療與再生醫學已是當前醫療產業最具發展潛力的新技術,隨著科學技術累積與突破,將具有活性的細胞、或透過基因改造的免疫細胞,當作藥物治療難治的疾病,或讓功能失調與受損的組織得以修復,如此的醫療效益讓再生醫學與細胞治療進而成為21世紀醫學的新治療方式,成為最受矚目的熠熠新星;然而幹細胞製造與產能不足,則成為細胞治療發展當前最大的隱憂。

為解決這項困難與障礙,博訊生技將於12月1日至4日於2022台灣醫療科技展,展示獨家顛覆細胞產業的3A﹒GTP技術,實現利用先進智慧自動化細胞製程,加速幹細胞治療應用,為台灣再造醫療產業奠定厚實的基礎。

再生醫療市場商機無限 博訊生技整合生物醫學與智慧自動化領域

根據Research and Markets的預估,2020年-2030年全球再生醫療市場的年均複合成長率將達到13.99%,市場規模為870.3億美元,其中約有580億美元為細胞製劑與細胞治療藥品生產,200億美元為組織工程,64億美元為基因治療產品,26億美元為血漿產品,細胞與基因治療將是未來生醫產業發展重要關鍵之一。而隨著衛生福利部公告《生技醫藥產業發展條例》,納入6種細胞治療項目,讓台灣在細胞治療領域中能在國際間快速達到彎道超車的目標。

博訊生技致力於整合生物醫學與智慧自動化領域,並提供專業與標準化細胞備製及代工服務,為世界上第一家有能力自主建置先進智能自動化細胞備製並實現先進製程產線的生技公司,並以CDMO細胞備製代工服務為主營運模式的廠商,相關的業界多以傳統GTP實驗室來提供細胞培養代工服務與開發和銷售自動化機器為主。

博訊生技董事長秘心吾表示,博訊生技多年以來投入智慧自動化細胞萃取、培養及儲存平台自主開發計畫,率先將實驗室細胞備製的所有流程SOP化,再將所有SOP化的流程自動化,自此開始得到並收集到許多數位轉型的參數,再進一步利用AI來管理和運算這些參數,最後建立智慧化與自動化細胞備製代工先進製程的產線和CDMO工廠。

秘心吾進一步說明:「過去細胞都是透過人工培養,但是細胞產業要快速發展,單靠人工培養細胞是無法滿足產業的需求,一定得靠製程的自動化,以先進的製程量化與標準化並符合法規製作細胞產品,才能大量生產出來具有同樣的品質的細胞。」秘心吾以資訊產品做例子指出,消費者手中的3C產品如筆電與手機,利用自動化工廠生產線,可以生產出一模一樣的產品,細胞產業若能透過自動化細胞製程的研發,就能解決人工的培養的不穩定與可能受到污染的問題,如此才能讓細胞產業達到一躍千里,讓目前有極限的醫療跨能大步、邁向新時代到來。 

突破細胞培養困境獨家研發3A﹒GTP技術 達到智慧工廠打破國家與區域限制 

博訊生技獨家研發的3A﹒GTP技術,利用人工智慧(AI)、擴增實境(AR)與自動化設備(Auto)來進行細胞組織優良操作規範(Good Tissue Practice, GTP ),以實現數位細胞製程的目標,同時配合博訊生技 iCell Technology 雲端大數據,利用先進智慧自動化細胞備製製程產線,可隨時優化與調整全線機構與各站製程參數,以達到最佳化自動工單及最大產能排程。

3A﹒GTP技術隨時進行質控管與即時修正通報,即使生產線位在不同區域或者不同國家,亦能透過遠端進行即時監控管理,並且自動提供最佳化戰略決策。透過博訊生技的3A﹒GTP技術就連生產細胞也能和生產資訊產品一樣,隨時以最佳化運作狀態生產細胞,達到24小時關燈無人工廠的模式。

博訊生技的3A﹒GTP技術提供幹細胞量產製程方面設置完整標準、衛生與無塵的作業空間,並且利用電腦化的管理系統與標準作業流程,與自動化細胞備製培養塔(Automated Cell Preparation Incubator)、自動化細胞光學辨識系統( AOI)、自動化細胞分注系統( Auto Dispensing and Passaging)、自動化細胞凍存系統 Cryostorage and Thaw讓細胞培養腔體容量大幅提升,並且優化幹細胞培植過程中所產生出高品質的精華液原料,自動化存取避免人工作業汙染,並且利用無線射頻識別系統(RFID)存取以準確掌握客戶資訊。

同時能將細胞備製製程SOP化、全製程參數數位化的3A﹒GTP技術,透過製程大數據雲端資料庫(Big Data Base/ Cloud),搭配博訊生技iCell Robot Series雲端大數據庫實現AI架構建立,實現符合國際醫療法規認證標準,在細胞生產過程中,品質監控圖像、數據皆可具體化紀錄並回溯,以確保細胞備製生產過程、細胞活性、品質穩定度及全製程環境無菌、無汙染安全性,並且實現細胞備製成本降低,讓生產製程能在安全與穩定的環境下生產,並且準時達成產品交期的目標。

博訊生技實現設備技術整廠輸出商業模式 加速幹細胞治療發展與應用

除此之外,博訊生技iCell Robot的智慧自動化細胞備製設備,讓細胞備製製程實現全自動化實現細胞萃取、培養製程、培養液分注、自動光學檢測細胞影像品質管控、離心製程、出貨冷凍儲存,全製程都可能自動化進行,並排除所有人為操作不穩定因素,實現全程無菌化細胞備製環境。   利用博訊生技3A﹒GTP技術將可加速優化幹細胞的生產速度與優化生產流程,提供最優質的幹細胞的產能,讓幹細胞也能大量生產,以滿足未來細胞產業發展對幹細胞的需求,解決幹細胞產能不足的燃眉之急,加速幹細胞治療發展與應用,讓生技產業快速發展,以滿足組織工程與再生醫學發展的相關需求,為台灣發展再生醫療產業助一臂之力。

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