Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vilobelimab API for pharmaceutical development, biopharmaceutical research, formulation development and regulated manufacturing applications.
Vilobelimab is a chimeric monoclonal antibody of the IgG4 class that specifically binds to complement component C5a. It is also known by the development code IFX-1. By binding to soluble C5a, Vilobelimab inhibits C5a-mediated inflammatory signaling and is being used in pharmaceutical development for complement-mediated inflammatory conditions.
Vilobelimab is identified by CAS No. 2250440-41-4 and has an approximate molecular mass of 148.5–148.6 kDa. Unlike conventional small-molecule pharmaceutical APIs, Vilobelimab is a complex biological molecule consisting of heavy and light antibody chains and is produced using mammalian cell culture technology.
Vilobelimab is a recombinant/chimeric monoclonal antibody targeting human complement component C5a. C5a is an important mediator of the complement system and contributes to inflammatory signaling, immune-cell activation and tissue inflammation.
Vilobelimab binds specifically to C5a and prevents C5a from interacting with its receptor, thereby reducing C5a-mediated inflammatory activity.
The active substance is a complex biological molecule rather than a conventional synthetic chemical compound. Its quality therefore depends on characteristics such as protein identity, purity, aggregation, charge variants, glycosylation, biological activity and other critical quality attributes.
FDA characterization describes Vilobelimab as a chimeric monoclonal IgG4 antibody containing murine-derived variable regions and human gamma-4 constant regions. The antibody contains approximately 1,328 amino acids and has an approximate molecular weight of 148.5–148.6 kDa.
Vilobelimab API is used in biopharmaceutical development and manufacturing of products targeting complement-mediated inflammatory pathways.
Key applications include:
Vilobelimab is the active substance in Gohibic, a medicine authorised in the European Union for adults with acute respiratory distress syndrome caused by SARS-CoV-2 who are receiving corticosteroids and mechanical ventilation, with or without extracorporeal membrane oxygenation.
The medicine is administered by intravenous infusion under specialist medical supervision.
In the United States, FDA issued an Emergency Use Authorization in April 2023 for Gohibic (vilobelimab) for certain hospitalized adults with COVID-19 when treatment is initiated within 48 hours of invasive mechanical ventilation or ECMO.
Vilobelimab requires specialized controls appropriate for a biological active pharmaceutical ingredient.
Unlike conventional small-molecule APIs, the quality assessment of Vilobelimab focuses on biological and protein-related critical quality attributes, including:
Manufacturing of Vilobelimab involves biological production technology using mammalian cells. Appropriate upstream processing, downstream purification, viral safety controls and aseptic processing are important elements of the manufacturing process.
Because monoclonal antibodies are structurally complex biological molecules, quality should be evaluated using validated analytical and biological assays appropriate to the active substance and intended regulatory market.
Swapnroop Drugs & Pharmaceuticals provides Vilobelimab API manufacturing and supply support for pharmaceutical and biopharmaceutical companies, formulation developers, research organizations and qualified customers involved in biological drug development.
As a Vilobelimab API manufacturer and supplier in India, Swapnroop supports requirements involving:
Vilobelimab is a biological protein and requires controlled storage and handling conditions to maintain its structural and biological integrity.
The finished product is supplied as a sterile solution and is stored under refrigerated conditions. FDA documentation supports a 24-month shelf life for the drug product when stored at 2–8°C under the evaluated conditions.
Vilobelimab should be protected from unsuitable temperatures, excessive agitation, light and other conditions that could affect protein stability.
Exact storage requirements for API or drug substance should follow the applicable manufacturer's stability data, validated storage conditions and controlled product specification.
Typical biopharmaceutical documentation may include:
Documentation requirements may vary according to the intended regulatory market and customer qualification requirements.
Quality control for Vilobelimab API requires a biological-product approach rather than conventional small-molecule API testing.
Important quality attributes can include protein identity, purity, aggregation, charge heterogeneity, glycosylation, concentration and biological activity. Process-related impurities such as host-cell proteins and residual host-cell DNA may also require appropriate control.
FDA documentation states that the Vilobelimab manufacturing and analytical control strategy supported the manufacture of material suitable for the EUA and included comparability assessment following manufacturing-process changes.
The European assessment identifies Vilobelimab as a monoclonal antibody that binds C5a and describes the active substance as the biological component of Gohibic.
For this reason, conventional small-molecule specification parameters such as melting point, specific rotation and simple aqueous solubility are not appropriate universal release tests for Vilobelimab.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biopharmaceutical manufacturers and qualified customers seeking Vilobelimab API for research, formulation, development and regulated biological manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Vilobelimab API Manufacturer and Supplier in India for monoclonal antibody, complement inhibitor and biopharmaceutical applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |