Teclistamab

Therapeutic Teclistamab antibody from the original Tecvayli® commercial drug.

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B cell maturation antigen
,
CD3
Bispecific Antibody
Tecvayli®
10 mg/mL
1 mg
-80°C
10/2024
398,00 
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Tecvayli® / Teclistamab Reference Product

Drug nameTecvayli®
INNTeclistamab
API typeBispecific antibody directed against the B cell maturation antigen (BCMA) and CD3 receptors, produced in a mammalian cell line (Chinese hamster ovary [CHO]) using recombinant DNA technology
Pharmacotherapeutic group
Other monoclonal antibodies and antibody drug conjugates
ATC code
L01FX24
Target of antibody
CD3 receptor expressed on the surface of T cells, B cell maturation antigen (BCMA) expressed on the surface of malignant multiple myeloma B-lineage cells
General functionTeclistamab is able to draw CD3+ T cells in close proximity to BCMA+ cells, resulting in T cell activation and subsequent lysis and death of BCMA+ cells, which is mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. This effect occurs without regard to T cell receptor specificity or reliance on major histocompatibility complex (MHC) Class 1 molecules on the surface of antigen presenting cells.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Teclistamab is a full-size, IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Within the first month of treatment, activation of T-cells, redistribution of T-cells, reduction of B-cells and induction of serum cytokines were observed. 18Within one month of treatment with teclistamab, the majority of responders had reduction in soluble BCMA, and a greater reduction in soluble BCMA was observed in subjects with deeper responses to teclistamab.
Original license holder
Janssen-Cilag International N.V.
Turnhoutseweg 30
Beerse
2340 Antwerp
Belgium
Marketing authorisation numbers
EU/1/22/1675/001 (10 mg/ml) EU/1/22/1675/002 (90 mg/ml)
Marketing authorisation holder
Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
Name of the manufacturer of the biological active substance
Janssen Sciences Ireland UC Barnahely, Ringaskiddy, Co. Cork Ireland
Name and address of the manufacturer(s) responsible for batch releaseJanssen Biologics B.V. Einsteinweg 101 2333 CB Leiden
The Netherlands

Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse
Belgium
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
EDTA disodium salt dihydrate Glacial acetic acid Polysorbate 20 (E432) Sodium acetate trihydrate Sucrose Water for injections