Tezepelumab is a recombinant human monoclonal antibody and a biologic API designed to target thymic stromal lymphopoietin (TSLP), an epithelial-cell-derived cytokine involved in inflammatory immune responses.
Tezepelumab is an IgG2λ monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It has a molecular weight of approximately 147 kDa. FDA identifies the CAS Registry Number as 1572943-04-4.
Tezepelumab is a targeted biologic active pharmaceutical ingredient belonging to the anti-TSLP monoclonal antibody class.
The molecule binds with high affinity to human TSLP and prevents TSLP from interacting with its heterodimeric receptor. Because tezepelumab is a complex recombinant protein, its quality evaluation relies on orthogonal biologics-specific analytical methods rather than conventional small-molecule API testing alone.
Tezepelumab consists of two heavy chains and two light chains characteristic of an IgG2 monoclonal antibody. EMA reports 448 amino acids in each heavy chain and 214 amino acids in each light chain, with 36 cysteine residues involved in disulfide bonding. Each heavy chain contains an N-linked glycosylation site at Asn298.
The theoretical molecular mass is approximately 144.3 kDa for the deglycosylated molecule and approximately 147.189 kDa when glycosylation is included. The experimentally determined glycosylated molecular mass reported by EMA is approximately 147.191 kDa.
Tezepelumab binds to human TSLP and blocks its interaction with the TSLP receptor complex.
TSLP is positioned upstream in the inflammatory cascade and can contribute to the initiation and persistence of airway inflammation. By blocking TSLP activity, tezepelumab reduces downstream inflammatory signaling and associated biomarkers.
Tezepelumab is the active substance in Tezspire, a biologic medicine used as an add-on maintenance treatment for severe asthma in adults and adolescents 12 years and older who remain inadequately controlled despite high-dose inhaled corticosteroids and another maintenance treatment.
EMA also currently lists tezepelumab as an add-on treatment for severe chronic rhinosinusitis with nasal polyps in adults when systemic corticosteroids and/or surgery do not provide adequate disease control.
Tezepelumab is administered by subcutaneous injection in the approved pharmaceutical product. The current EMA product information describes Tezspire as a 210 mg solution in a pre-filled syringe or pre-filled pen, with a concentration of 110 mg/mL.
Tezepelumab API requires comprehensive biologics-specific analytical characterization. Important quality attributes include:
FDA identifies a receptor-ligand binding assay as the potency assay for tezepelumab and evaluates product quality attributes including molecular characterization and subvisible particles.
EMA reports that tezepelumab's characterization includes molecular mass, glycosylation, cysteine/disulfide structure, isoelectric point and thermal properties.
Swapnroop Drugs and Pharmaceuticals is a WHO-GMP certified pharmaceutical company engaged in pharmaceutical APIs and pharmaceutical raw materials for domestic and international markets.
Tezepelumab API can be evaluated according to applicable biologics quality requirements, customer-specific specifications and regulatory expectations. Product-specific analytical documentation can be provided according to the intended pharmaceutical development and manufacturing requirements.
Tezepelumab is a protein biologic and requires controlled storage conditions to maintain its structural and functional integrity.
The approved Tezspire drug product is supplied as an aqueous protein solution in pre-filled delivery systems. EMA product information specifies storage of the finished medicinal product under controlled refrigerated conditions and protection from freezing and excessive heat. API storage should follow the validated stability program and product-specific storage specification.
Technical documentation for Tezepelumab API may include:
Swapnroop Drugs and Pharmaceuticals operates as a WHO-GMP certified pharmaceutical company with a portfolio of pharmaceutical APIs and pharmaceutical raw materials.
For Tezepelumab API requirements, customers can request product specifications, analytical documentation, quality information, packaging details and commercial information according to their pharmaceutical development, manufacturing and regulatory requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |