在生命科学研究与生物医药开发领域,培养基作为细胞生长的 "土壤",其质量直接决定研发效率与成果转化的安全性,然而,当前行业在培养基使用中仍面临多重挑战,如 1)质量波动风险:传统培养基因成分复杂,存放过程中易出现絮状沉淀、分层等物理性状改变,导致细胞培养结果不可控。2)批间差异难题:非化学成分限定的生产模式,使得不同批次产品成分比例偏差可达40%,造成实验重复性差,尤其对临床申报材料的稳定性验证构成挑战。3)安全合规隐患:含动物源成分(如牛血清、水解蛋白),可能引入病毒、朊蛋白等外源因子污染风险,阻碍药物申报;
面对上述挑战,ACROBiosystems百普赛斯以临床级标准为导向,构建高质量、可追溯、符合法规要求的细胞培养基产品体系,以化学成分限定、无动物源、高批间一致性为核心优势,为细胞治疗研发提供更安全、更稳定、更合规的培养解决方案。
成分透明化: 所有原料均采用化学合成或重组表达技术生产,实现100% 成分可追溯。以 CelThera™系列培养基为例,其氨基酸、维生素、无机盐等组分均明确分子量与结构,彻底摒弃动物源提取物。
生产标准化: B+A 级环境,严格遵循ISO9001/ ISO13485 质量管理体系。每批次产品需通过关键指标检测(包括内毒素—基础培养基<0.05EU/mL,补充液<10EU/mL、无菌测试、细胞增殖率等)。
国际合规性: 所有 GMP 级产品均完成 FDA DMF 备案,可直接引用用于 IND/NDA 申报,助力客户加速全球注册进程。
无血清、无人源动物源成分、高安全性
对不同组织来源(脐带、骨髓、脂肪)的MSCs均有优异的扩增能力
保持不同组织来源的MSCs多次传代后的良好活率
高效维持MSCs成脂、成骨、成软骨的多向分化潜能
Human PBMCs were activated using 0.2 µg/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (ACROBiosystems, Cat. No. GMP-MC0323) and 1 µg/mL GMP Monoclonal Anti-Human CD28 Antibody (ACROBiosystems, Cat. No. GMP-MC2824), cultured with CelThera™ GMP T Cell Expansion culture medium (ACROBiosystems, Cat. No. GMP-CM3101) supplemented with 500 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) for two weeks. The results showed that GMP human IL-2 protein, GMP monoclonal anti-human CD3 antibody (OKT3), GMP monoclonal anti-human CD28 antibody and CelThrea™ GMP T cell expansion medium could be used to culture T cells in a 3L large system. It can efficiently expand cells with high viability.
Cell ratio of the human various T cells. Human PBMCs were activated using 0.2 µg/mL GMP Monoclonal Anti-Human CD3 Antibody (OKT3) (ACROBiosystems, Cat. No. GMP-MC0323) and 1 µg/mL GMP Monoclonal Anti-Human CD28 Antibody (ACROBiosystems, Cat. No. GMP-MC2824), and cultured in CelThera™ GMP T Cell Expansion culture medium (ACROBiosystems, Cat. No. GMP-CM3101) supplemented with 500 IU/mL GMP Human IL-2 Protein (ACROBiosystems, Cat. No. GMP-L02H14) for two weeks. The result shows that percentage of CD3+ cells in living cells is above 99%. At the end of the culture process, the majority memory phenotype of T cells are TN/SCM, followed by TCM, which means that the cell harvest will have a promising effect, such as sustained proliferation, prolonged survival, and so on.
使用3E7冻存外周血来源PBMC种子细胞,20 mL 起始体积连续补液扩增, 13天扩增至3 L,收获超70亿细胞,第13天NK细胞纯度高于97%。整体培养周期更短
3E6冷冻保存的PBMC(外周血来源)种子细胞,以3mL的初始体积在底部带有透气膜的规模化静置培养反应器中进行连续饲养扩增。14天后,体积扩大到2000mL,收获了超过60亿个细胞,且收获时,γδT细胞纯度超过93%。