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>产品&服务 > FDA DMF备案系列产品

FDA DMF备案系列产品

背景
产品特点
产品列表
产品数据
背景
药品主文件（Drug Master Files, DMF）是持有者递交给FDA的存档药物文件，主要涉及产品的质量标准、检验方法、生产工艺描述、纯度、稳定性等保密细节信息，这些信息用于支持新药临床试验申报（IND）、新药注册（NDA）和生物制品许可证申请（BLA）。
ACROBiosystems部分自主开发的重组蛋白产品已完成美国FDA DMF备案（FDA DMF编号：034936），您相关的CAR-T细胞治疗或抗体药物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。
引用DMF编号授权：
如果您使用了ACRO的DMF备案系列产品并需要引用DMF编号，请向ACRO提出授权申请，收到申请后，我们将向FDA中心提供DMF授权书。点击申请授权
产品特点
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
FDA DMF备案产品列表
分子名称 货号 产品描述
CD19 CD9-HF2H2 FITC-Labeled Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-HF251 FITC-Labeled Human CD19 (20-291) Protein, Fc Tag DMF Filed
CD9-H8259 Biotinylated Human CD19, Fc Tag, ultra sensitivity (primary amine labeling) DMF Filed
CD9-H52H2 Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-H5251 Human CD19 (20-291) Protein, Fc Tag, low endotoxin (Super affinity, MALS verified) DMF Filed
CD9-HP2H3 PE-Labeled Human CD19 (20-291) Protein, His Tag (Site-specific conjugation)
CD9-H82E9 Biotinylated Human CD19 (20-291) Protein, His,Avitag™ (SPR verified)
BCMA BCA-HF2H1 FITC-Labeled Human BCMA / TNFRSF17 Protein, His Tag DMF Filed
BCA-HF254 FITC-Labeled Human BCMA / TNFRSF17 Protein, Fc Tag DMF Filed
BCA-H82E4 Biotinylated Human BCMA / TNFRSF17 Protein, His,Avitag™ DMF Filed
BC7-H82F0 Biotinylated Human BCMA / TNFRSF17 Protein, Fc,Avitag™ DMF Filed
BCA-H522y Human BCMA / TNFRSF17 Protein,His Tag (HPLC-verified) DMF Filed
BC7-H5254 Human BCMA / TNFRSF17 Protein, Fc Tag (HPLC verified) DMF Filed
BCA-HP2H2 PE-Labeled Human BCMA / TNFRSF17 Protein, His Tag (Site-specific conjugation)
FMC63 FM3-Y45 Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-Y45A1 Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Carrier-free) (recommended for ADA assay)
FM3-Y45P1 Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (HEK293)
FM3-FY45 FITC-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-BY54 Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1, Avitag™ (Y45)
FM3-HPY53 PE-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Site-specific conjugation)
ROR1 RO1-H5250 Human / Cynomolgus / Rhesus macaque ROR1 Protein, Fc Tag (MALS verified)
Siglec-2 CD2-H52H8 Human Siglec-2 / CD22 Protein, His Tag (MALS verified)
Mesothelin MSN-HP2H5 PE-Labeled Human Mesothelin / MSLN (296-580) Protein, His Tag (Site-specific conjugation)
MSN-H82E9 Biotinylated Human Mesothelin / MSLN (296-580) Protein, His,Avitag™ (MALS verified)
CD4 LE3-H5228 Human CD4 / LEU3 Protein, His Tag (MALS verified)
CD4-HF255 FITC-Labeled Human CD4 Protein, Fc Tag
CD4-H5259 Human CD4 Protein, Fc Tag (MALS verified)
EGFRvIII EGI-HF2H7 FITC-Labeled Human EGFRvIII Protein, His Tag
EGFR EGR-HF2H5 FITC-Labeled Human EGF R Protein, His Tag
RBD SPD-M180 Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Human IgG1 (AM180）
Nuclease GMP-NUES19 GMP GENIUS™Nuclease DMF Filed
PH20 / SPAM1 PH0-H5225 Human PH20 / SPAM1 Protein, His Tag (active enzyme)

>>> 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

产品数据
经流式验证FITC-Labeled CD19蛋白能够特异性检测Anti-CD19 CAR 表达
293 cells were transfected with anti-CD19-scFv and RFP tag. 2e5 of the cells were stained with FITC-Labeled Human CD19 (20-291), Fc Tag (Cat. No. CD9-HF251, 10 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-CD19-scFv) expression and FITC was used to evaluate the binding activity of FITC-Labeled Human CD19 (20-291), Fc Tag (Cat. No. CD9-HF251) (QC tested).
Protocol
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).
Protocol
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).
Protocol
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).
Protocol

>>> 点击查看更多CAR-T靶点信息

>>> 点击查看更多CD19详细信息——高亲和力CD19蛋白，专为检测CD19-CAR-T而设计

>>> 点击查看更多Anti-FMC63 scFv Ab详细信息-更加灵敏检测Anti-CD19 (FMC63) CAR的特异性抗体

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