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近年來，細胞治療産(chǎn)品，尤其是嵌合抗原受體(tǐ)T細胞（CAR-T）的研發與臨床應用(yòng)發展迅猛。在美國(guó)臨床試驗網站檢索全球CAR-T細胞治療臨床試驗登記數可(kě)以發現，中(zhōng)國(guó)所登記的項目數僅次于美國(guó)，居全球第二。迄今為(wèi)止，國(guó)内已有(yǒu)近二十家公(gōng)司拿(ná)到了CAR-T細胞療法的臨床批件[1]。
疾控中(zhōng)心的建設要符合我國(guó)現行的生物(wù)安(ān)全實驗室各項标準，目前國(guó)際上依據實驗室所處理(lǐ)對象的生物(wù)危險程度，把生物(wù)安(ān)全實驗室分(fēn)為(wèi)四級：一級對生物(wù)安(ān)全隔離的要求最低，四級最高。我國(guó)目前有(yǒu)兩個四級生物(wù)安(ān)全實驗室：湖(hú)北武漢BSL-4病毒實驗室（中(zhōng)國(guó)科(kē)學(xué)院武漢國(guó)家生物(wù)安(ān)全實驗室 ）和國(guó)家動物(wù)疫病防控高級别生物(wù)安(ān)全實驗室（中(zhōng)國(guó)農業科(kē)學(xué)院哈爾濱獸醫(yī)研究所）。
Digitising process development can reduce the time delay between sampling and availability, and can increase the quality of the data obtained
Process control is a central task in bioprocess development and production. Apart from common control tasks including pH, temperature or dissolved oxygen, more advanced control tasks must be mastered. Real-time availability of analytical data is ofte
To facilitate optimal process control limiting substrates must be identified, moni-tored and controlled. Amino acids are often critical substances, especially in mam-malian processes. Measurement and thus monitoring is tedious and rarely done.
