Vunakizumab is a recombinant humanized monoclonal antibody and an active pharmaceutical ingredient belonging to the class of targeted biological therapies. It specifically targets interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in immune-mediated inflammatory diseases. Vunakizumab is also known by its development code SHR-1314 and is classified as a recombinant human IgG1/kappa monoclonal antibody.
Vunakizumab selectively binds to IL-17A and inhibits its interaction with the IL-17 receptor. By blocking IL-17A-mediated signaling, Vunakizumab can reduce downstream inflammatory responses associated with diseases such as plaque psoriasis and other inflammatory disorders.
The substance is identified by CAS Number 1792181-33-9 and FDA Global Substance Registration System UNII Y4U029R8MS. Its reported molecular weight is approximately 146.38 kDa.
Vunakizumab is a large recombinant protein rather than a conventional low-molecular-weight chemical API. It is a humanized IgG1/kappa monoclonal antibody designed to recognize and neutralize human IL-17A.
The antibody is produced using mammalian cell expression technology, with CHO-cell systems reported for recombinant Vunakizumab production. Its molecular size is approximately 146.38 kDa, which is characteristic of a full-length immunoglobulin G monoclonal antibody.
Because Vunakizumab is a biological molecule, its identity and quality cannot be adequately described using only conventional chemical parameters such as molecular formula, melting point or residue on ignition. Instead, characterization focuses on molecular identity, protein concentration, purity, aggregation, charge variants, biological activity and process-related impurities.
Vunakizumab acts as a selective IL-17A inhibitor. IL-17A is an inflammatory cytokine that participates in signaling pathways involved in the development and maintenance of chronic inflammatory diseases.
Vunakizumab binds specifically to IL-17A and prevents IL-17A from interacting with its receptor. This reduces IL-17A-mediated inflammatory signaling and downstream production of inflammatory mediators.
The mechanism makes Vunakizumab relevant to targeted biological treatment strategies involving the IL-17A pathway. Its pharmacological classification is therefore anti-IL-17A monoclonal antibody.
Vunakizumab API is relevant to pharmaceutical manufacturers, biotechnology companies, biological formulation developers and research organizations working with targeted immunological therapies.
As a Vunakizumab API manufacturer and supplier in India, the product can be positioned for pharmaceutical development, analytical research and biological manufacturing applications requiring controlled-quality recombinant monoclonal antibody material.
Quality control for Vunakizumab should be designed specifically for biological products. Important attributes include antibody identity, protein concentration, purity, aggregate level, molecular integrity, charge heterogeneity, host-cell proteins, residual host-cell DNA, endotoxins, bioburden and biological activity.
Vunakizumab is a targeted biological medicine developed for inflammatory and immune-mediated diseases. In China, Vunakizumab injection was approved for adults with moderate-to-severe plaque psoriasis who are candidates for systemic treatment or phototherapy. The approved product is described as a recombinant humanized IgG1 anti-IL-17A monoclonal antibody.
Clinical development has also evaluated Vunakizumab in other inflammatory conditions associated with IL-17A signaling, including psoriatic arthritis and axial spondyloarthritis.
For pharmaceutical manufacturing and research, Vunakizumab can be categorized as an anti-IL-17A API, monoclonal antibody API, recombinant biological API, immunology API and psoriasis-related biological ingredient.
Unlike conventional pharmaceutical chemicals, Vunakizumab does not have a simple low-molecular-weight chemical formula suitable for routine API characterization. It is a recombinant immunoglobulin molecule with a reported molecular weight of approximately 146.38 kDa.
Research-grade Vunakizumab is described as a liquid, with a color ranging from colorless to light yellow. Commercial research specifications report Vunakizumab as a human IgG1/kappa monoclonal antibody.
A research-grade Vunakizumab preparation has been reported in a buffer system containing 100 mM proline and 20 mM arginine at pH 5.0. This is a formulation/buffer value and should not be represented as a universal pharmaceutical API pH specification.
Other research preparations use different buffers, including PBS around pH 7.4–7.5, demonstrating that pH and formulation conditions depend on the particular preparation.
Quality control of Vunakizumab requires analytical methods appropriate for recombinant monoclonal antibodies.
SEC-HPLC can be used to evaluate molecular-size variants and aggregation, while SDS-PAGE can provide information about protein integrity and purity. Peptide mapping and mass spectrometry can support identity confirmation. Binding and cell-based assays can be used to evaluate biological activity against IL-17A.
Additional quality attributes may include protein concentration, charge variants, glycosylation profile, host-cell proteins, residual DNA, endotoxin, bioburden and visible or subvisible particles.
Because Vunakizumab is a biological API, the release specification should be based on validated analytical procedures and the applicable regulatory dossier rather than generic chemical API specifications.
Vunakizumab, also known as SHR-1314, was developed as a humanized monoclonal antibody targeting IL-17A.
Recombinant Vunakizumab has been expressed in Chinese hamster ovary (CHO) cells, followed by purification and analytical characterization. Published research has used high-performance size-exclusion chromatography to evaluate antibody purity and aggregation and functional assays to assess IL-17A neutralization.
The development of Vunakizumab reflects the growing use of targeted monoclonal antibodies in inflammatory and autoimmune diseases. Its selective IL-17A mechanism provides a targeted approach for diseases in which IL-17 signaling contributes to pathological inflammation.
Vunakizumab is a recombinant protein produced using mammalian cell culture technology. CHO-cell expression is reported for recombinant Vunakizumab, followed by protein purification to obtain the antibody product.
For pharmaceutical manufacturing, biological-process controls are required throughout cell culture, harvest, purification, viral clearance and final formulation.
Important manufacturing controls include protein concentration, aggregation, purity, charge variants, glycosylation, host-cell protein removal, residual DNA control, endotoxin control and biological potency.
The final formulation and buffer system should be established according to the applicable pharmaceutical product specification and stability program.
Vunakizumab biological material should be stored according to the applicable product specification, stability data and certificate of analysis.
Research-grade preparations are commonly stored under refrigerated or frozen conditions depending on the formulation. For example, one research preparation recommends 2–8°C for short-term use, −20°C for up to 12 months and −80°C for long-term storage.
Another research preparation uses −20°C storage and recommends avoiding repeated freeze-thaw cycles. These differences demonstrate why storage conditions should be based on the specific formulation and validated stability data rather than applying one generic temperature to every Vunakizumab preparation.
Vunakizumab is a specialized recombinant monoclonal antibody targeting IL-17A. Its biological mechanism and clinical development make it relevant to the development of targeted therapies for inflammatory diseases.
For pharmaceutical manufacturers and biotechnology developers, appropriate control of identity, protein concentration, purity, aggregation, biological activity, charge variants, glycosylation, host-cell proteins, residual DNA, endotoxins and bioburden is important for maintaining consistent biological API quality.
Vunakizumab can be positioned as a monoclonal antibody API, anti-IL-17A biological API, recombinant antibody API, immunology API and pharmaceutical biotechnology ingredient.
Vunakizumab is a recombinant humanized IgG1/kappa monoclonal antibody that specifically targets interleukin-17A. It is also known as SHR-1314 and has CAS Number 1792181-33-9 and FDA UNII Y4U029R8MS.
Vunakizumab has a reported molecular weight of approximately 146.38 kDa and is generally described as a recombinant liquid antibody preparation with a color ranging from colorless to light yellow.
Its mechanism involves binding IL-17A and inhibiting IL-17A-mediated inflammatory signaling. Vunakizumab has been developed for inflammatory diseases, including moderate-to-severe plaque psoriasis, and was approved in China for this indication in adults.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 5.0 |
| Melting Point | 150°C – 154°C |