博瑞策生物專注于生物藥物合規(guī)性質(zhì)量及安全檢測服務(wù)，在上海和蘇州兩地共建設(shè)有超過16,000㎡符合cGMP+GLP+BSL-2的檢測服務(wù)平臺、商務(wù)辦公及培訓(xùn)中心。博瑞策生物嚴(yán)格遵循各國藥典和國內(nèi)外法規(guī)，已經(jīng)獲得EU GMP QP、FDA FEI Number、ISO9001: 2015、BSL-2、CMA、CNAS等認(rèn)證資質(zhì)，確保檢測結(jié)果的真實(shí)性、有效性和數(shù)據(jù)完整性，其符合國際質(zhì)量標(biāo)準(zhǔn)的生物藥物評價體系，支持生物制劑、細(xì)胞基因治療、核酸藥物、疫苗等生物藥物產(chǎn)品質(zhì)量評價。目前，博瑞策生物具備包括動物體內(nèi)實(shí)驗(yàn)在內(nèi)的全部生物安全檢測服務(wù)能力，通過一體化服務(wù)，拒絕再轉(zhuǎn)包，穩(wěn)定且可控的質(zhì)量體系能夠覆蓋藥物生物安全檢測的全部項(xiàng)目和全生命周期。秉承高效交付、科學(xué)嚴(yán)謹(jǐn)?shù)姆?wù)理念，博瑞策生物已經(jīng)建立具有自主知識產(chǎn)權(quán)的生物安全檢測能力，通過了近百家國內(nèi)外頭部生物藥企審計(jì)，并已成功遞交多個中美IND和BLA項(xiàng)目。作為助力您成功的生物安全檢測合作伙伴，我們?yōu)榭蛻籼峁┥锇踩珯z測一站式高質(zhì)量服務(wù)，加速創(chuàng)新生物醫(yī)藥產(chǎn)品申報上市。
BRC Biotechnology, a leading force in the realm of biosafety testing services, specializing in providing biosafety testing services for biological products of global clients in accordance with international standards. Founded in Shanghai in 2022, BRC Biotechnology has cGMP/BSL-2 testing and GLP/animal testing centers. We offer biosafety testing and assay development for cell/gene therapy, antibodies, and vaccines. Our multi-platform capabilities support NMPA, EMA, and FDA submissions for IND/BLA. Since 2022, we have successfully delivered nearly a hundred FDA and EU international projects, helping our clients accelerate their applications. Given that our clients are leading global biopharmaceutical companies, time is of the essence. We ensure that our clients' new drugs are applied in clinical settings in a timely manner and guarantee the safety of patients' medication.
我們?yōu)槟峁?/strong>
? GMP生產(chǎn)細(xì)胞建庫及檢定
? 藥物原液及產(chǎn)品檢測服務(wù)
? 定制化產(chǎn)品檢測技術(shù)開發(fā)
? 生產(chǎn)工藝病毒清除驗(yàn)證服務(wù)
? 產(chǎn)品質(zhì)量合規(guī)性技術(shù)咨詢
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