博瑞策生物專(zhuān)注于生物藥物合規性質(zhì)量及安全檢測服務(wù)，在上海和蘇州兩地共建設有超過(guò)16,000㎡符合cGMP+GLP+BSL-2的檢測服務(wù)平臺、商務(wù)辦公及培訓中心。博瑞策生物嚴格遵循各國藥典和國內外法規，已經(jīng)獲得EU GMP QP、FDA FEI Number、ISO9001: 2015、BSL-2、CMA、CNAS等認證資質(zhì)，確保檢測結果的真實(shí)性、有效性和數據完整性，其符合國際質(zhì)量標準的生物藥物評價(jià)體系，支持生物制劑、細胞基因治療、核酸藥物、疫苗等生物藥物產(chǎn)品質(zhì)量評價(jià)。目前，博瑞策生物具備包括動(dòng)物體內實(shí)驗在內的全部生物安全檢測服務(wù)能力，通過(guò)一體化服務(wù)，拒絕再轉包，穩定且可控的質(zhì)量體系能夠覆蓋藥物生物安全檢測的全部項目和全生命周期。秉承高效交付、科學(xué)嚴謹的服務(wù)理念，博瑞策生物已經(jīng)建立具有自主知識產(chǎn)權的生物安全檢測能力，通過(guò)了近百家國內外頭部生物藥企審計，并已成功遞交多個(gè)中美IND和BLA項目。作為助力您成功的生物安全檢測合作伙伴，我們?yōu)榭蛻?hù)提供生物安全檢測一站式高質(zhì)量服務(wù)，加速創(chuàng )新生物醫藥產(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(kāi)發(fā)
? 生產(chǎn)工藝病毒清除驗證服務(wù)
? 產(chǎn)品質(zhì)量合規性技術(shù)咨詢(xún)
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