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FDA DMFファイルタンパク質
ドラッグマスターファイル(DMF)とは、企業が製品の品質基準、検査方法、製造プロセスの説明、純度、安定性などの詳細情報を米食品医薬品局(FDA)に登録する医薬品ファイルのことです。登録した情報は、試験薬申請(IND)、新薬申請(NDA)と生物製剤ライセンス申請(BLA)のために利用されます。
ACROBiosystemsが独自で開発した組換えタンパク質製品の一部は、米国FDA DMFファイリング(FDA DMF番号:034936)登録を完了しています。CAR-T細胞療法や抗体薬物の研究において、臨床応用または新薬登録の際には弊社のDMF番号を直接引用いただけます。時間を節約でき、臨床応用の準備プロセスを加速できます。
DMF番号の引用:
弊社のDMF申請済みのタンパク質製品を利用し、DMF番号を引用されたい方はお問い合わせください。弊社よりFDAにDMF承認書を提出します。お問い合わせはこちら
非標識、蛍光標識、ビオチン化タンパク質など、様々なタンパク質を提供できます。
生物活性はFlow cytometry、SPR、ELISAによって検証されています。
CAR発現検出、抗体薬物スクリーニングに適しています。
分子名 | 製品番号 | 説明 |
---|---|---|
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-BY45 | Biotinylated 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) |
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, Fc Tag (Cat. No. CD9-HF251) (QC tested).
Human CD19, 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).
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).
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