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Your Position: Home > FDA DMFファイルタンパク質

FDA DMFファイルタンパク質

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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

特長
  1. 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。

  2. 生物活性はFlow cytometry、SPR、ELISAによって検証されています。

  3. CAR発現検出、抗体薬物スクリーニングに適しています。

FDA DMF申請済みのタンパク質製品一覧
分子名製品番号説明
CD19CD9-HF2H2FITC-Labeled Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-HF251FITC-Labeled Human CD19 (20-291) Protein, Fc Tag DMF Filed
CD9-H8259Biotinylated Human CD19, Fc Tag, ultra sensitivity (primary amine labeling) DMF Filed
CD9-H52H2Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-H5251Human CD19 (20-291) Protein, Fc Tag, low endotoxin (Super affinity, MALS verified) DMF Filed
CD9-HP2H3PE-Labeled Human CD19 (20-291) Protein, His Tag (Site-specific conjugation)
CD9-H82E9Biotinylated Human CD19 (20-291) Protein, His,Avitag™ (SPR verified)
BCMABCA-HF2H1FITC-Labeled Human BCMA / TNFRSF17 Protein, His Tag DMF Filed
BCA-HF254FITC-Labeled Human BCMA / TNFRSF17 Protein, Fc Tag DMF Filed
BCA-H82E4Biotinylated Human BCMA / TNFRSF17 Protein, His,Avitag™ DMF Filed
BC7-H82F0Biotinylated Human BCMA / TNFRSF17 Protein, Fc,Avitag™ DMF Filed
BCA-H522yHuman BCMA / TNFRSF17 Protein,His Tag (HPLC-verified) DMF Filed
BC7-H5254Human BCMA / TNFRSF17 Protein, Fc Tag (HPLC verified) DMF Filed
BCA-HP2H2PE-Labeled Human BCMA / TNFRSF17 Protein, His Tag (Site-specific conjugation)
FMC63FM3-Y45Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-Y45A1Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Carrier-free) (recommended for ADA assay)
FM3-Y45P1Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (HEK293)
FM3-FY45FITC-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-BY45Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-BY54Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1, Avitag™ (Y45)
FM3-HPY53PE-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Site-specific conjugation)
ROR1RO1-H5250Human / Cynomolgus / Rhesus macaque ROR1 Protein, Fc Tag (MALS verified)
Siglec-2CD2-H52H8Human Siglec-2 / CD22 Protein, His Tag (MALS verified)
MesothelinMSN-HP2H5PE-Labeled Human Mesothelin / MSLN (296-580) Protein, His Tag (Site-specific conjugation)
MSN-H82E9Biotinylated Human Mesothelin / MSLN (296-580) Protein, His,Avitag™ (MALS verified)
CD4LE3-H5228Human CD4 / LEU3 Protein, His Tag (MALS verified)
CD4-HF255FITC-Labeled Human CD4 Protein, Fc Tag
CD4-H5259Human CD4 Protein, Fc Tag (MALS verified)
EGFRvIIIEGI-HF2H7FITC-Labeled Human EGFRvIII Protein, His Tag
EGFREGR-HF2H5FITC-Labeled Human EGF R Protein, His Tag
RBDSPD-M180Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Human IgG1 (AM180)
NucleaseBEE-N3116GENIUS™Nuclease
PH20 / SPAM1PH0-H5225Human PH20 / SPAM1 Protein, His Tag (active enzyme)
>>> ほかFDA DMFファイリングを希望する方は、こちらをクリックしてお問い合わせください。Click here
データ
フローサイトメトリーによってFITC-Labeled CD19タンパク質はAnti-CD19 CARの発現を特異的に検出できます(フローサイトメトリーによって確認されている)。

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).

ヒトCD19タンパク質の親和定数は0.17nMです(SPRによって確認されている)。

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).

抗BCMACAR発現のFACS分析

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).

ヒトBCMAタンパク質の親和定数は0.388nMです(SPRによって確認されている)。

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).

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