聯(lián)生藥（揚(yáng)州)的生物制藥研發(fā)與生產(chǎn)基地,占地 1.3 萬(wàn)平米,提供一站式 CDMO 服務(wù),從原液到藥品的無(wú)菌灌裝 cGMP 生產(chǎn)。生產(chǎn)規(guī)模涵蓋 50L/200L/500L/2000L,  支持前臨床和臨床的 IND 報(bào)批,以及后期 BLA 審批和早期的商業(yè)化生產(chǎn)。我們 團(tuán)隊(duì)擁有超過(guò) 10 年的單抗和重組蛋白生產(chǎn)經(jīng)驗(yàn), 實(shí)現(xiàn)了 6+個(gè)創(chuàng)新藥物在中國(guó)和 美國(guó)的臨床報(bào)批。持續(xù)地精進(jìn)與強(qiáng)化生物工藝,在質(zhì)量源于設(shè)計(jì)和質(zhì)量風(fēng)險(xiǎn)管理 的原則下,確保產(chǎn)品整個(gè)生命周期的質(zhì)量并且符合經(jīng)濟(jì)效益。透過(guò)建立靈活的伙 伴關(guān)系,以及一體化的服務(wù)平臺(tái): 高效敬業(yè)的項(xiàng)目團(tuán)隊(duì), 國(guó)際標(biāo)準(zhǔn)的質(zhì)量管理, 優(yōu) 質(zhì)的 CMC 文件, 全方位支持客戶完成個(gè)階段的研發(fā)和報(bào)批任務(wù)。

The R&D and production base of United Biopharma(Yangzhou) covers an area of  13,000 square meters and provides one-stop CDMO services for cGMP production of  drug substance and drug product by aseptic filling, which production scale includes  50L/200L/500L/2000L, supporting pre-clinical and clinical IND approval, as well as  the later BLA approval and early commercial production. Our team has more than 10  years of experience in the production of mAb and recombinant proteins, and has  achieved clinical approval of 6+ innovative biologics in China and the United States.  Continue to improve and intensify the bioprocess, meanwhile ensure the product quality  during R&D life cycle, balanced with the economic benefits under implementing quality-by-design and quality risk management. Through the establishment of flexible  partnerships, and an integrated service platform: efficient and dedicated project team,  international standard quality management, high-quality CMC documents, all-round  support for our clients to accomplish each R&D stage and IND approval tasks.