FDA DMF备案意义在哪？看ACRO蛋白如何助力CAR-T项目申报

根据美国联邦食品、药品和化妆品法规定，药品在上市之前申报者必须向FDA提出相关的申请，比如临床研究申请（IND）、新药注册（NDA）和生物制品许可证申请（BLA）等，并需要提供该药物在安全性、有效性和质量三方面的全部信息^[2]，其中涉及到原料药、辅料的相关技术内容，但是准备这些材料无疑会耗费大量的时间和精力，同时原料供应商也不愿透漏自己的技术信息，因此严重影响临床申报的进程。

为解决这一问题，FDA建立了DMF体系，原料供应商以DMF文件的形式将所需的技术内容直接交给FDA备案并获得备案编号，药物申报者可以直接使用DMF备案编号来代替申报过程中需要提供有关原料和辅料的具体信息^[3]，极大程度上缩短了审查和评估时间。

ACROBiosystems自主开发的CD19和BCMA蛋白系列产品已完成美国FDA DMF备案（FDA DMF编号：034936），您的CAR-T细胞治疗研究项目进行临床申请或新药注册的监管备案文件中可直接引用我们的DMF编号，从而节约产品审查和评估时间，缩减新药临床申报的准备工作。

ACRO DMF备案产品列表

如果您有其他产品的FDA DMF备案需求，欢迎联系我们。点击咨询

> 覆盖非标记、荧光标记和生物素标记蛋白多种形式

> 蛋白活性经Flow cytometry、SPR、ELISA验证

> 适用于CAR表达检测和抗体药筛选

经流式验证PE-Labeled CD19蛋白能够特异性检测Anti-CD19 CAR 表达

1e6 of the anti-CD19 CAR-293 cells were stained with 100 μL of 1:50 dilution (2 μL stock solution in 100 μL FACS buffer) of PE-Labeled Human CD19 (20-291), His Tag (Cat. No. CD9-HP2H3). PE Streptavidin was used as negative control (QC tested)

经SPR验证Human CD19蛋白的亲和力常数为0.17 nM

Human CD19 (20-291), Fc Tag, low endotoxin (Super affinity) (Cat. No. CD9-H5251) captured on CM5 chip via Anti-Human lgG Fc antibodies surface, can bind FMC63 MAb (mouse lgG2a) with an affinity constant of 0.17 nM as determined in a SPR assay (Biacore T200) (Routinely tested). 

FITC-Labeled Human BCMA流式检测Anti- BCMA CAR表达

293 cells were transfected with anti-BCMA-scFv and RFP tag. 2e5 of the cells were stained with FITC-Labeled Human BCMA, His Tag (Cat. No. BCA-HF2H1, 1 µg/ml) and FITC-labeled protein control. Non-transfected 293 cells and FITC-labeled protein control were used as negative control. RFP was used to evaluate CAR (anti-BCMA-scFv) expression and FITC was used to evaluate the binding activity of FITC-Labeled Human BCMA, His Tag (Cat. No. BCA-HF2H1) (QC tested).

经SPR验证Human BCMA蛋白的亲和力常数为0.388 nM

Anti-BCMA Neutralizing Antibody, Mouse IgG1 (Clone: AM43, Cat. No. BCA-M43) captured on CM5 chip via anti-mouse antibodies surface can bind Human BCMA, His Tag (Cat. No. BCA-H522y) with an affinity constant of 0.388 nM as determined in a SPR assay (Biacore T200) (Routinely tested).

更多CAR-T靶点蛋白系列产品

>　全部CAR-T靶点蛋白产品

＞　CD19蛋白产品

＞　CD22蛋白产品

＞　MSLN蛋白产品

＞　抗FMC63抗体产品

参考文献：

[1] https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs

[2] Federal Food Drug and Cosmetic Act

[3] https://www.fda.gov/drugs/guidances-drugs/drug-master-files-guidelines