上海貝融生物基因工程有限公司（BETAGENE? Genetic，貝融生物?）致力于重組蛋白生物試劑的研發(fā)與生產(chǎn)。貝融生物?的重組蛋白生產(chǎn)中心位于上海外高橋保稅區(qū)，生產(chǎn)面積達2000㎡，具備成熟的原核與真核表達體系。潔凈車間設有發(fā)酵、純化、制劑、質(zhì)量四個區(qū)域，其中制劑車間設有西林瓶、預灌封、凍干三條生產(chǎn)線。凈化區(qū)域設立C、B、A等級，符合ISO9001與ISO13485，并已投入GMP運營，可滿足藥物中試規(guī)模。
貝融生物?為國內(nèi)外生物制藥公司、醫(yī)療公司、科研單位提供快速、優(yōu)質(zhì)、專業(yè)的GMP級細胞因子、酶制劑及蛋白試劑，同時提供蛋白質(zhì)定制與蛋白質(zhì)藥物開發(fā)等服務。這些產(chǎn)品可用于細胞培養(yǎng)、細胞及基因治療、抗體純化、疫苗制備、體外診斷、化妝品及醫(yī)療器械等行業(yè)。貝融生物?建立了嚴格的產(chǎn)品質(zhì)控體系以及完善的客戶服務流程、保密制度，以確保能為客戶提供優(yōu)質(zhì)的產(chǎn)品及頂級的服務。
Product quality control has been our top priority from day one, by ensuring every aspect of our quality management system - from management of raw materials and equipment to facilities maintenance (environmental monitoring), manufacturing processes, internal audits and inspection processes - is in compliance with relevant GMPs and all applicable regulatory and standard requirements. Cytokines are manufactured and tested in compliance with relevant cGMP regulations、ISO 9001:2015 and ISO 13485:2016 standards.
The company has been assessed and registered as meeting the requirements of ISO9001:2015 and 13485:2016 in 2022. The scope of approval includes design, production and sales of biological reagents (biological enzyme preparations, cells, recombinant proteins). The company has been dedicated to becoming world class biological reagents supplier and delivering top quality recombinant protein products to life science industry.
