goldennet

OCT.19
2021

ITRI Collaborates with Genomics to Build GMP Vaccine Nucleic Acid Adjuvant Plant

工研院與基龍米克斯生物科技公司(4195)於今(19)日共同宣布,簽訂建構核酸合成GMP工廠輔導合約,由工研院協助基龍米克斯打造GMP核酸合成廠,預計明年第三季可望正式生產,初期產量可滿足國內1280萬劑疫苗(如:新冠肺炎等)製造所需,未來最大產量估計可供應超過五千萬劑,在工研院的輔導下,基龍米克斯可望成為國內首家有能力自行生產GMP等級「疫苗核酸佐劑」的生技公司,協助國產疫苗廠商將原料採購在地化,未來還可擴大其應用性,供應全球核酸類藥物的原料,有助於帶動國內新藥研發產業產值提升。

test

工研院與基龍米克斯生物科技公司共同簽訂「建構核酸合成GMP工廠輔導合約」,協助國產疫苗廠商將原料採購在地化,帶動國內新藥研發產業產值提升。圖中貴賓自左三起,依序為:工研院生醫與醫材研究所副所長黃崇雄、所長林啟萬、基龍米克斯董事長周孟賢、總經理江浚錡。

工研院生醫與醫材研究所所長林啟萬表示,在經濟部技術處科技專案支持下,工研院在大/小分子藥、天然物、醫材、甚至化妝品等領域,累積了豐富的GMP工廠輔導經驗。2020年新冠肺炎疫情崛起時,經濟部技術處超前部署,支持工研院以科技開發核酸檢測試劑與系統、正壓採檢亭、呼吸器等多項防疫科技,護衛臺灣最前線。現今進入後疫情的階段,疫苗是防疫重要物資,就目前疫苗生產來看,GMP核酸製造廠的建立是疫苗生產相當重要步驟,透過這次合作,可望協助業者的生產提高至GMP藥廠等級,開發國產佐劑,預計未來每年可提供1,280萬劑以上數量,滿足國內疫苗廠的需求,同時,也可以讓合作業者基龍米克斯切入核酸藥物委託研究開發暨生產服務(Contract Development and Manufacturing Organization, CDMO),帶動生技產業國產化。


基龍米克斯總經理江浚錡指出,臺灣通過PIC/S GMP評鑑之藥廠約200餘家,其中尚缺乏GMP認可之核酸合成廠。且近年面臨新冠肺炎疫情,全球疫苗需求大增,國產疫苗以生產蛋白質次單元類型疫苗為主力,所需之核酸佐劑現階段臺灣尚無業者有能力自行生產GMP等級原料供貨,完全仰賴進口以滿足需求。協同工研院的輔導,升級公司現有技術,發展GMP核酸合成產品,是公司發展現階段最重要的前進方向。接著更要打造GMP多肽合成廠、建構多肽庫,讓公司發展成具有研發能量的CDMO工廠。


在新冠肺炎疫情下,各國紛紛強化疫苗製造能力,而疫苗製造國產化的關鍵之一正是「佐劑」。對於「次單位疫苗、去活化疫苗」這兩種疫苗來說,佐劑不僅可讓疫苗打入人體後更有效果,而且需要的劑量更少,以目前國產的新冠肺炎疫苗來說,就是使用蛋白質次單元疫苗技術,因此需添加佐劑作為輔助。根據市場研究公司Mordor Intelligence指出,2020年全球疫苗佐劑市場價值約6.6億美元(逾新台幣180億元),預計2026年可衝上14.7億美元(逾新台幣400億元),期間的複合年增長率(CAGR)達13.37%。然而,目前臺灣國產疫苗廠多是跨海向歐美訂購佐劑,成本負擔重。


在佐劑市場中,核酸藥物的前景看俏,工研院與基龍米克斯合作導入GMP核酸合成廠,藉由擴增產能與設備升級,除可以更立即供應國產疫苗核酸佐劑,加速國產疫苗研發生產外,未來也能與國內外藥廠合作進行核酸藥物之研發與生產;預計今年底完成建廠並開始檢驗製程確效,有望於2022年第三季正式投產。

Other News

Other News

Building Key Capabilities for Vaccine Adjuvants: GMP Nucleic Acid Synthesis Plant Completed

The pandemic has highlighted the importance of local vaccine production. The Industrial Technology Research Institute (ITRI) and Genomics Bioscience & Technology Co. Ltd., (4195) jointly announced today (23rd) the completion of the nucleic acid synthesis plant, supported by the Department of Industrial Technology, MOEA. Assisted by ITRI, the plant is expected to receive ISO certification in October and commence production in the fourth quarter. This plant aims to address the market gap where vaccine nucleic acid adjuvants must be sourced from abroad, imposing a heavy cost burden and uncertainty in procurement. The goal is to achieve the “localization of vaccine manufacturing and autonomy in raw material production”. Additionally, the plant will collaborate with domestic and international pharmaceutical companies to supply raw materials for nucleic acid drugs, thereby enhancing Taiwan's biomedical new drug industry.

MAR.24
2022

Genomics to Develop Agricultural Genomics Database

"By Tsai Wu Mu │Moneyweekly Issue 1010│2020-01-03

Despite the stagnation in the precision medicine market, Genomics, a leading gene sequencing company, has adopted a strategy of agile advancement. Since July 2018, they have partnered with the Taiwan Livestock Research Institute under the Ministry of Agriculture, leveraging “whole-genome + artificial intelligence” to aid in pig breeding and mating. They have successfully completed data models for pig selection and mating and are planning to apply these models across various domains, including other livestock and aquaculture. This initiative is aimed at establishing Taiwan's pioneering agricultural genomics database, which is anticipated to generate significant business opportunities."

JAN.03
2020

Top

Contact

Contact Us

Contact

Contact Us

Search

Search Entire Website

Search for products or news