Pre-made Brentuximab benchmark antibody ( Whole mAb ADC, anti-TNFRSF8 therapeutic antibody, Anti-CD30/Ki-1/D1S166E Antibody) for drug discovery and mechanism of action (MOA) research

Cat No.: GMP-Bios-ab-080

Pre-Made Brentuximab biosimilar, Whole mAb ADC, Anti-TNFRSF8 Antibody: Anti-CD30/Ki-1/D1S166E therapeutic antibody is a biosimilar expressed by mammalian cell line as a benchmark reference therapeutic antibody for biological drug disovery items including cell culture, assay development, animal model development, PK/PD model development (Pharmacokinetics & Pharmacodynamic) and mechanism of action (MOA) research.

Brentuximab vedotin (INN; trade name Adcetris) is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL. The drug is being jointly marketed by Millennium Pharmaceuticals outside the US and by Seattle Genetics in the US.

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Catalog No. Package Price(In USD) Qty (Quantity) Sum(In USD)
GMP-Bios-ab-080-1mg 1mg 4635
GMP-Bios-ab-080-10mg 10mg Inquiry
GMP-Bios-ab-080-100mg 100mg Inquiry
GMP-Bios-ab-080-xmg ≥100mg Inquiry
Shipping Cost: 760.00
Total:



Description

Products Name (INN Index) Pre-Made Brentuximab biosimilar, Whole mAb ADC, Anti-TNFRSF8 Antibody: Anti-CD30/Ki-1/D1S166E therapeutic antibody
INN Name Brentuximab
Target TNFRSF8
Format Whole mAb ADC
Derivation
Species Reactivity Human
CH1 Isotype IgG1
VD LC Kappa
Highest_Clin_Trial (Jan '20) Approved
Est. Status Active
100% SI Structure None
99% SI Structure None
95-98% SI Structure None
Year Proposed 2010
Year Recommended 2011
Companies Bristol-Myers Squibb;Celgene Corporation;Dana-Farber Cancer Institute;Fondazione Italiana Linfomi;Fox Chase Cancer Center;Immune Tolerance Network;Lymphoma Academic Research Organisation;Massachusetts General Hospital;National Cancer Institute (USA);National Institute of Allergy and Infectious Diseases;Seattle Genetics;Stanford University;Takeda;Takeda Oncology;UNC Lineberger Comprehensive Cancer Center;Washington University School of Medicine
Conditions Approved Anaplastic large cell lymphoma;Cutaneous T-cell lymphoma;Hodgkin's disease;Mycosis fungoides;T-cell lymphoma
Conditions Active Adult T-cell leukaemia-lymphoma;Diffuse large B cell lymphoma;Germ cell and embryonal neoplasms;Mastocytosis;Mesothelioma;Non-Hodgkin's lymphoma;Peripheral T-cell lymphoma;Sezary syndrome;Diffuse scleroderma
Conditions Discontinued Graft-versus-host disease;Leukaemia;Multiple myeloma;Solid tumours;Systemic lupus erythematosus
Development Tech na


Case study


Antibody Payload QC
Ab-001 VCMMAE SDS-PAGE(reducing and non-reducing)
Human IgG1 Control DAR
Ab-002 Cytotoxity assay

First, we used a higher dose of reducing agent (TCEP) and small toxic molecule (vcmmae) to ensure the success of coupling. SDS-PAGE (reducing DTT & non reducing DTT) results showed that we successfully linked MMAE to the antibody. Here you are the conjugate manufacturing.

1. human IgG1-ADC: SDS-PAGE (reducing) and SDS-PAGE (non-reducing)

2. DAR detect

In this batch, we selected 5.4 equivalent TCEP and 10.8 equivalent VCMMAE groups for DAR detection. The DAR of our sample is almost the same as that of the standard sample, but the integrity of the antibody result is not as good as that of the standard sample.

3. cytotoxity assay

At next step, we did cytotoxity assay to observe the toxic effect of ADC on 293 cells. At the same time, considering the storage and transportation of ADC, we lyophilized ADC and compared the effect of non-lyophilized on ADC cytotoxicity.
Obviously, compared with the blank group, ADC had a significant inhibitory effect on the growth of 293 cells. Moreover, lyophilized can reduce the inhibition of ADC on cell growth.

The results show that when the equivalent of reducing agent TCEP is 0.4 and 1.5, the results do not have regularity, which may be caused by the limited opening of disulfide bond and the limited coupling of small molecules. However, when the equivalent of TCEP is 3, the results can match the previous PTM-1-ADC (5.4t5.4v & 5.4t10.8). We also deal 293-ko cell line with PTM-1-ADC, obviously, there is no regular relationship between cell death and ADC dose.

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Figure. QC and functional verification of ADC(human IgG1-MMAE).
Figure C and figure D: LC-MS to detect the DAR(drug-to-antibody ratio) of ADC. Figure C is positive control and figure D is the ADC made by ourselves. Both are human IgG1-MMAE.
Figure C and figure D: LC-MS to detect the DAR(drug-to-antibody ratio) of ADC. Figure C is positive control and figure D is the ADC made by ourselves. Both are human IgG1-MMAE.
Figure E and figure F: ADC cytotoxicity assay.