Tralokinumab is a recombinant human IgG4 monoclonal antibody that specifically targets and neutralizes interleukin-13 (IL-13). It is an established biologic API used in the treatment of moderate-to-severe atopic dermatitis. Tralokinumab is marketed in the European Union as Adtralza and in the United States as Adbry (tralokinumab-ldrm).
Tralokinumab is produced using recombinant DNA technology in mouse myeloma cells. The FDA describes the antibody as consisting of 1,326 amino acids with an approximate molecular weight of 147 kDa. It is a human IgG4 antibody and specifically binds human IL-13, preventing IL-13 from interacting with its receptor subunits.
Tralokinumab is an IL-13 antagonist. IL-13 is an important cytokine involved in type 2 inflammatory responses and is strongly associated with the pathophysiology of atopic dermatitis. By binding IL-13, tralokinumab inhibits IL-13 interaction with the IL-13Rα1/IL-4Rα receptor complex and IL-13Rα2.
EMA's assessment reports that tralokinumab has been comprehensively characterized for its primary and higher-order structure, charge heterogeneity, size heterogeneity, glycosylation and biological activity.
Tralokinumab is used for the treatment of moderate-to-severe atopic dermatitis in patients who are candidates for systemic therapy. EMA currently describes Adtralza for adult and adolescent patients 12 years and older.
The current EMA product information describes Adtralza as a clear to opalescent, colourless to pale-yellow injectable solution with a pH of 5.5. Each pre-filled syringe contains 150 mg in 1 mL, while the 300 mg pre-filled pen contains 300 mg in 2 mL.
Swapnroop Drugs & Pharmaceuticals provides pharmaceutical and biologic API sourcing support for Tralokinumab for qualified pharmaceutical, biotechnology and formulation-development requirements.
As a Tralokinumab API manufacturer and supplier in India, Swapnroop focuses on specification-based biologic sourcing, product characterization, quality documentation, traceability and appropriate cold-chain handling where required.
Tralokinumab is a biological monoclonal-antibody substance and should be stored and transported according to validated stability conditions and the applicable drug-substance specification.
The finished Adtralza product is stored refrigerated. The finished-product storage condition should not be interpreted as a universal bulk drug-substance storage specification.
Documentation may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology companies seeking Tralokinumab API manufacturer and supplier services in India.
The supply approach emphasizes biologic product identity, structural characterization, biological activity, purity/impurity control, documentation and appropriate storage and transportation requirements.
For bulk Tralokinumab API requirements, customers can contact Swapnroop for product availability, technical specifications, documentation and commercial supply information.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |