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CN-121779564-B - Anti-CD 38 recombinant rabbit monoclonal antibody and application thereof

CN121779564BCN 121779564 BCN121779564 BCN 121779564BCN-121779564-B

Abstract

The invention relates to the technical field of antibodies, in particular to an anti-CD 38 recombinant rabbit monoclonal antibody and application thereof. The anti-CD 38 recombinant rabbit monoclonal antibody provided by the invention has high specificity and high sensitivity in combination with CD38 protein molecules, can specifically identify and detect the expression of CD38 protein on cells, is positive and high in expression when detecting CD38 protein, is found through immunohistochemical detection of various different tissues, can be applied to detection and screening fields such as IHC, ELISA, immunoblotting, antibody chip preparation, flow cytometry and the like, and is beneficial to obtaining accurate assessment and detection results. Compared with the existing anti-CD 38 antibody, the 645J4B5 cloned CD38 recombinant rabbit monoclonal antibody has the characteristics of good specificity, strong positive signals and the like, is easier to score in IHC staining, is more accurate in detecting and distinguishing cancers, and is suitable for popularization and application.

Inventors

  • YANG BIN
  • CHEN QINGHUI
  • ZHANG ZHENGYU
  • LV QINGFU
  • CHEN QINGCAI
  • Chu Genglei
  • LI MIANXIAN
  • ZHANG SHENG
  • SUN DALIN
  • KONG LINGJUN

Assignees

  • 苏州大学附属第一医院

Dates

Publication Date
20260512
Application Date
20260305

Claims (9)

  1. 1. The anti-CD 38 recombinant rabbit monoclonal antibody is characterized in that the amino acid sequences of 3 CDR regions of a heavy chain are shown in SEQ ID NO. 1,2 and 3 respectively, and the amino acid sequences of 3 CDR regions of a light chain are shown in SEQ ID NO.4, 5 and 6 respectively.
  2. 2. The recombinant rabbit monoclonal antibody against CD38 according to claim 1, wherein the amino acid sequence of the heavy chain variable region is shown in SEQ ID NO. 7 and the amino acid sequence of the light chain variable region is shown in SEQ ID NO. 8.
  3. 3. A nucleic acid molecule encoding the anti-CD 38 recombinant rabbit monoclonal antibody of claim 1 or 2.
  4. 4. The nucleic acid molecule of claim 3, wherein the heavy chain has a nucleotide sequence shown in SEQ ID NO. 9 and the light chain has a nucleotide sequence shown in SEQ ID NO. 10.
  5. 5. A biomaterial comprising at least one of the following ①~③: ① . An expression vector comprising the nucleic acid molecule of claim 3 or 4; ② . Transforming or transfecting a host cell of the expression vector described in ①; ③ . Culturing ② said host cells to obtain a culture comprising said anti-CD 38 recombinant rabbit monoclonal antibody.
  6. 6. A labeled antibody comprising a label and an anti-CD 38 recombinant rabbit monoclonal antibody according to claim 1 or 2.
  7. 7. The labeled antibody of claim 6, wherein the label comprises a chemical label and a biomarker; the chemical marker includes an isotope; the biomarker comprises biotin, avidin or an enzyme.
  8. 8. Application of at least one of the following I-IV in preparation of immunodetection reagent: I. The anti-CD 38 recombinant rabbit monoclonal antibody of claim 1 or 2; II. The nucleic acid molecule of claim 3 or 4; III, the biological material of claim 5; IV, the labeled antibody of claim 6 or 7.
  9. 9. The immunodetection reagent is characterized by comprising at least one of the following i-iv: i. The anti-CD 38 recombinant rabbit monoclonal antibody of claim 1 or 2; ii. The nucleic acid molecule of claim 3 or 4; iii, the biomaterial of claim 5; iv, the labeled antibody of claim 6 or 7.

Description

Anti-CD 38 recombinant rabbit monoclonal antibody and application thereof Technical Field The invention relates to the technical field of antibodies, in particular to an anti-CD 38 recombinant rabbit monoclonal antibody and application thereof. Background CD38 protein has a molecular weight of 34kDa, belongs to type II transmembrane glycoprotein, is a member of the ADP-ribosyl transferase superfamily and is also known as ADP-ribosyl cyclase/cyclo-ADP-ribosylase 1, NAD (+) nucleotidase. CD38 is widely expressed on the surface of various immune cells, such as activated T cells, B cells, plasma cells, natural killer cells, etc., and plays a role in the development, activation, proliferation, and immunomodulation of immune cells, etc. As immune cell receptors, are involved in cell migration regulation, signal transduction and receptor-mediated adhesion, helping immune cells to better recognize and cope with foreign pathogens. However, the binding specificity and sensitivity of the CD38 antibody currently marketed with CD38 protein molecules need to be improved, and the recognition degree in IHC staining is poor, which is not beneficial to detection and differentiation, resulting in limited application fields of the CD38 antibody currently marketed. Because of the existence of the homologous protein CD157 of the CD38 protein, nonspecific cross reaction is easy to occur during immunohistochemical detection, and the expression deletion of the CD38 protein exists in partial tumor cells (such as CD38 negative myeloma), the complementary detection needs to be realized by combining with other markers (CD 138). There is therefore a need to develop monoclonal antibodies with higher specificity, avoiding cross-reactions. Disclosure of Invention In view of the above, the technical problem to be solved by the invention is to provide an anti-CD 38 recombinant rabbit monoclonal antibody and application thereof, and the invention provides a monoclonal antibody capable of specifically recognizing CD38 protein and a preparation method thereof, which have high sensitivity and strong specificity and can avoid cross reaction in detection. The invention provides an anti-CD 38 recombinant rabbit monoclonal antibody, which is characterized by comprising the following components: (1) The amino acid sequences of the 3 CDR regions of the heavy chain are shown as SEQ ID NO. 1,2 and 3 respectively, the amino acid sequences of the 3 CDR regions of the light chain are shown as SEQ ID NO. 4, 5 and 6 respectively, or (2) An amino acid sequence obtained by substituting, deleting or adding one or more amino acids in the amino acid sequence of (1) and functionally identical or similar to the amino acid sequence of (1), or (3) A CDR having at least 90% sequence identity to the amino acid sequence of (1) or (2). In some embodiments, the amino acid sequences of the 3 CDR regions of the heavy chain variable region are set forth in SEQ ID NOs 1, 2 and 3; the amino acid sequences of the 3 CDR regions of the light chain variable region are shown in SEQ ID NOs 4,5 and 6. In some embodiments of the present invention, in some embodiments, (4) The heavy chain variable region has an amino acid sequence shown as SEQ ID NO. 7, the light chain variable region has an amino acid sequence shown as SEQ ID NO. 8, or (5) An amino acid sequence obtained by substituting, deleting or adding one or more amino acids to the amino acid sequence of (4) and functionally identical or similar to the amino acid sequence of (4), or (6) An amino acid sequence having at least 90% homology with the sequence of (4) or (5). In some embodiments, the amino acid sequence of the heavy chain variable region is shown in SEQ ID NO. 7 and the amino acid sequence of the light chain variable region is shown in SEQ ID NO. 8. The invention provides nucleic acid molecules encoding the anti-CD 38 recombinant rabbit monoclonal antibodies. In some embodiments, the nucleic acid molecule has: (7) The heavy chain of the polypeptide has a nucleotide sequence shown as SEQ ID NO. 9, the light chain of the polypeptide has a nucleotide sequence shown as SEQ ID NO. 10, or (8) A nucleotide sequence obtained by modifying, substituting, deleting or adding one or more bases to the nucleotide sequence according to (7), or (9) A sequence having at least 90% homology with the nucleotide sequence of (7) or (8), or (10) The nucleotide sequence of (7), (8) or (9). In some embodiments, the heavy chain has a nucleotide sequence shown in SEQ ID NO. 9 and the light chain has a nucleotide sequence shown in SEQ ID NO. 10. The present invention provides a biomaterial comprising at least one of the following ①~③: ① . An expression vector comprising the nucleic acid molecule; ② . Transforming or transfecting a host cell of the expression vector; ③ . Culturing the host cell to obtain a culture containing the anti-CD 38 recombinant rabbit monoclonal antibody. In some embodiments, the invention also provides an expression module