概述：
機(jī)械攪拌多級(jí)生物反應(yīng)器是一種新型生物反應(yīng)器，其選材和制造工藝符合CGMP要求。在放大操作過程中為重組蛋白藥物提供理想的生理和產(chǎn)物的物理環(huán)境，滿足生產(chǎn)菌株生長、代謝，藥物合成，維持生物動(dòng)力學(xué)性能和傳質(zhì)混合及空間結(jié)構(gòu)要求。
應(yīng)用范圍：
廣泛用于生物高技術(shù)產(chǎn)業(yè)的中試，生產(chǎn)規(guī)模包括單克隆抗體、病毒疫苗、干擾素、tPA、白介素、G-CSF等所有用于大腸桿菌表達(dá)產(chǎn)品的基因工程生物制品。
優(yōu)點(diǎn)：
1. 罐體根據(jù)不同產(chǎn)物需求，可設(shè)計(jì)不同高徑比的罐體。
2.無泄露裝置，消除交叉污染，符合CGMP要求,運(yùn)行平穩(wěn)，噪音低。
3. 采用德國博格曼機(jī)械雙端面密封+KENOD自行開發(fā)組件, 替代進(jìn)口無菌密封。
4. 軸與葉輪采用特殊一體式加工，保證葉輪在高速下的平衡運(yùn)轉(zhuǎn)。
5. 攪伴槳備有十幾種不同的工程菌株,可供選擇。
6. 生物反應(yīng)器在發(fā)酵放大后仍保持較高的一致性和生產(chǎn)率，控制系統(tǒng)采用可調(diào)諧的PID控制回路全自動(dòng)控制。
Application scope：
Widely used in biological high-tech industrial pilot, the scale of production including monoclonal antibodies, virus vaccine, interferon, tPA and interleukin, G-CSF etc. all used for e. coli express product genetic engineering of biological products.
Advantages：
1. Tank requirements for different products can be designed with different aspect ratio of the tank.
2. Completely leak-free installations, eliminating cross-contamination, consistent with CGMP requirements, sterile and stable operation, low noise.
3. Adopted the German Burgmann mechanical double seal+KENOD develop their own components, completely replace imported sterile seal.
4. Axis impeller machining using the special one, to ensure the balance of the impeller at high speed operation .
5. Stir equipped with a dozen different engineering strains, with choices to be made.
6. Bioreactor in the fermentation amplification remained high after the consistency and productivity, control system can be tuned PID control loop automatic controled.
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