Swapnroop Drugs & Pharmaceuticals offers Tildrakizumab as a specialized biologic pharmaceutical active substance for research, development, and pharmaceutical manufacturing applications. Tildrakizumab is a recombinant, humanized IgG1/kappa monoclonal antibody that selectively targets the p19 subunit of interleukin-23 (IL-23).
Tildrakizumab is manufactured using recombinant DNA technology in Chinese hamster ovary (CHO) cells. Regulatory characterization describes the molecule as consisting of two identical heavy chains and two identical light chains linked through disulfide bonds, with glycosylation occurring on the heavy-chain Fc region.
Tildrakizumab is an anti-IL-23 monoclonal antibody used in the management of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It works by selectively binding the p19 subunit of IL-23 and preventing its interaction with the IL-23 receptor.
The molecule has an approximate molecular mass of 147 kDa according to regulatory product information. Its reported molecular formula is C6426H9918N1698O2000S46, and its CAS Registry Number is 1326244-10-3.
| Parameter | Details |
|---|---|
| Product Name | Tildrakizumab |
| CAS No. | 1326244-10-3 |
| Molecular Formula | C6426H9918N1698O2000S46 |
| Molecular Mass | Approx. 147 kDa |
| Molecular Type | Recombinant humanized monoclonal antibody |
| Immunoglobulin Class | Humanized IgG1/kappa |
| Target | Interleukin-23 (IL-23) p19 subunit |
| Expression System | Recombinant CHO cell line |
| ATC Code | L04AC17 |
| Therapeutic Category | Interleukin inhibitor / Immunomodulator |
Regulatory characterization confirms that tildrakizumab is produced in recombinant CHO cells and undergoes structural characterization using techniques including mass spectrometry, peptide mapping and N-glycan profiling.
Tildrakizumab is primarily associated with biologic therapies targeting IL-23-mediated inflammatory pathways. Its established pharmaceutical application is the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
It is supplied as a biologic drug substance/active ingredient for incorporation into appropriate pharmaceutical development and manufacturing processes.
Tildrakizumab specifically binds to the p19 subunit of IL-23 without binding to IL-12. This prevents IL-23 from interacting with its receptor and inhibits downstream inflammatory signaling, including the release of pro-inflammatory cytokines and chemokines.
As a monoclonal antibody, Tildrakizumab requires a biologics-oriented analytical control strategy rather than the conventional small-molecule API tests normally used for crystalline chemical substances.
Typical characterization and quality-control approaches include:
Health Canada states that the control strategy for tildrakizumab includes acceptance criteria covering identity, quantity, purity, potency, impurities and safety parameters, with validated or qualified analytical methods.
Swapnroop Drugs & Pharmaceuticals focuses on pharmaceutical active ingredients and specialized biologic products with emphasis on quality systems, analytical characterization, controlled manufacturing practices and regulatory documentation.
For Tildrakizumab, biologic-specific characterization and quality attributes should be controlled according to the applicable approved product specification and customer/regulatory requirements rather than applying specifications intended for conventional small-molecule APIs.
Tildrakizumab is a temperature-sensitive biologic. Regulatory manufacturing information indicates that formulated bulk drug substance may be stored at ≤ -40 ± 5°C, while the finished medicinal product is refrigerated at 2°C to 8°C and protected from light.
Storage conditions for bulk API/drug substance should always follow the manufacturer's approved specification and validated stability data.
Depending on the product grade and applicable requirements, documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| pH (1% Solution) | 5.7–6.3 |