LONZA X-VIVO 15 免疫细胞无血清培养基

细胞治疗和基因治疗发展如火如荼，继2017年2个细胞治疗产品获得美国FDA上市批准后，同年年底，中国国家食品药品监督管理总局也发布了《细胞治疗产品研究与评价技术指导原则（试行）》，为提高细胞治疗产品的安全性、有效性提供了法律依据，使我国细胞治疗的发展进入快车道。

细胞治疗和基因治疗过程，均涉及到从患者体内分离血液细胞，通过体外扩大培养，再输回患者体内的过程，而培养基的安全性，是保证免疫细胞培养的重要一环。

瑞士LONZA集团，在全球拥有100余个生产基地和办事处，全球员工14500余人，是著名的生物技术、制药、特殊成分供应商，多年来为基因治疗、过继免疫治疗及其他细胞疗法开发了众多研究工具。

LONZA X-VIVO 15 免疫细胞培养基，作为LONZA最畅销的无血清培养基，可为免疫细胞提供营养平衡完善的体外培养环境，已成功应用于T细胞、造血干细胞、单核细胞、巨噬细胞、CIK、自然杀伤细胞、外周血淋巴细胞、树突状细胞、淋巴因子激活杀伤细胞、肿瘤浸润淋巴细胞、粒细胞的培养中。

LONZA X-VIVO 15 培养基，不含外源生长因子、人工细胞增殖刺激因子、蛋白激酶C刺激剂，所有成分明确，含有重组人胰岛素、重组人转铁蛋白和白蛋白，并针对肿瘤浸润淋巴细胞（TIL）的体外无血清培养进行了优化，近年来在众多CAR-T研究中得到使用。

Serum-free media outperforms serum-based media and maintains phenotype, with secondary suppliers for cytokines.T-cells (1x106) were stimulated with CD3/CD28 Dynabeads in both 6-well plates (5 ml) and a closed system breathable vessel(35 ml) with different media. The serum-free X-VIVO media supported the largest expansion of T-cells, comparable to RPMI supplemented with human serum in both open and closed systems and outperforming several serum-free media alternatives

LONZA X-VIVO 15 已在美国FDA进行备案。为满足细胞治疗行业对产品质量和安全性的高标准， 生产用途的X-VIVO 15培养基由拥有ISO13485质量管理认证的美国或欧洲工厂生产，严格按照cGMP标准，不含抗生素、不含酚红，且全部标记为FFM (For Further Manufacture)。用于科研及研发用途的X-VIVO 15培养基，添加抗生素及酚红，并标记为RUO(Research Use Only)。

相关文献：

Highly efficient therapeutic gene editing of human hematopoietic stem cells.(Nature Medicine,2019)

Bacteria-free minicircle DNA system to generate integration-free CAR-T cells.(J Med Genetics,2019,56: 10-17)

Genome-wide CRISPR Screens in Primary Human T Cells Reveal Key Regulators of Immune Function.(Cell,2018,175(7):1985-1971)

A high-fidelity Cas9 mutant delivered as a ribonucleoprotein complex enables efficient gene editing in human hematopoietic stem and progenitor cells.(Nature Medicine,2018,24(8): 1216-1224)

Clinical grade manufacturing of genetically modified, CAR-expressing NK-92 cells for the treatment of ErbB2-positive malignancies. (Cancer Immunol Immunother,2018,67(1):25-38) 

Improved Expansion and In Vivo Function of Patient T Cells by a Serum-free Medium.(Molecular Therapy,2018,8:65-74)

Genetic Inactivation of CD33 in Hematopoietic Stem Cells to Enable CAR T Cell Immunotherapy for Acute Myeloid Leukemia.(Cell,2018,173(6):1439-1453)

Targeting a CAR to the TRAC locus with CRISPR/Cas9 enhances tumour rejection.(Nature,2017,543(7643):113-117)

A genome-wide CRISPR screen identifies a restricted set of HIV host dependency factors.(Nature Genetics,2016,49(2):193-203)

High efficacy and safety of low-dose CD19-directed CAR-T cell therapy in 51 refractory or relapsed B acute lymphoblastic leukemia patients.(Leukemia,2017,31:2587-2593)

Co-stimulatory signaling determines tumor antigen sensitivity and persistence of CAR T cells targeting PSCA+ metastatic prostate cancer. (OncoImmunology,2017,7(2))

A genome-wide CRISPR screen identifies a restricted set of HIV host dependency factors.(Nature Genetics,2016,49(2):193-203)

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——北京泽平，LONZA中国地区一级代理商