Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Vedolizumab API for biopharmaceutical development, pharmaceutical formulation, research and regulated pharmaceutical manufacturing applications.
Vedolizumab is a recombinant humanized monoclonal antibody (mAb) belonging to the IgG1 class. It is a targeted biological active pharmaceutical ingredient that binds specifically to the α4β7 integrin expressed on a subset of lymphocytes involved in gastrointestinal immune responses. By blocking the interaction between α4β7 integrin and mucosal addressin cell adhesion molecule-1 (MAdCAM-1), vedolizumab reduces the migration of these cells into gastrointestinal tissues.
Vedolizumab is the active substance in pharmaceutical products used for the treatment of ulcerative colitis and Crohn's disease and is also indicated in the European Union for certain patients with chronic pouchitis.
Vedolizumab is a recombinant humanized IgG1 monoclonal antibody consisting of two heavy chains and two kappa light chains. The antibody contains disulfide bonds characteristic of IgG1 molecules and N-linked glycosylation sites on the heavy chains.
Regulatory characterization describes vedolizumab as a recombinant humanized IgG1 monoclonal antibody directed against human α4β7 integrin. Its predicted mass for the unmodified protein is approximately 146,837 Da, while the glycosylated antibody has a molecular mass around the 147 kDa range.
Because Vedolizumab is a biological monoclonal antibody rather than a conventional small-molecule API, its quality assessment requires protein-specific analytical methods and product-specific biological specifications.
The EMA classifies vedolizumab under immunosuppressants and monoclonal antibodies and identifies α4β7 integrin as its molecular target.
Vedolizumab API is used in the development and manufacture of biological pharmaceutical products targeting inflammatory diseases of the gastrointestinal tract.
Key applications include:
Vedolizumab selectively targets the α4β7 integrin pathway involved in the trafficking of certain lymphocytes to gastrointestinal tissues.
As a recombinant monoclonal antibody, Vedolizumab requires a biological manufacturing and quality-control framework different from that used for conventional chemical APIs.
Important quality attributes may include:
A generic small-molecule assay such as 98–102% HPLC should not be applied to Vedolizumab as a universal API specification. Product quality should instead be evaluated using validated biological and physicochemical analytical methods appropriate for the specific monoclonal antibody.
Swapnroop Drugs & Pharmaceuticals provides Vedolizumab API manufacturing and supply support for pharmaceutical and biotechnology customers involved in therapeutic protein development and regulated pharmaceutical manufacturing.
As a Vedolizumab API manufacturer and supplier in India, Swapnroop focuses on controlled biological API quality, product-specific specifications, analytical documentation and pharmaceutical supply requirements.
Vedolizumab API can support:
Vedolizumab should be handled and stored according to the applicable biological API specification and validated stability requirements.
The material should be protected from unsuitable temperature conditions, excessive environmental exposure and physical conditions that may affect protein stability.
Appropriate pharmaceutical-grade containers and controlled handling procedures should be used according to the specific product presentation and manufacturing requirements.
Typical documentation for Vedolizumab API may include:
Documentation availability depends on the applicable product grade, regulatory market and customer requirements.
Quality control of Vedolizumab API requires characterization appropriate for recombinant monoclonal antibodies.
Critical quality attributes may include identity, purity, molecular size, aggregation, charge heterogeneity, glycosylation, protein concentration and biological activity.
The EMA assessment describes Vedolizumab as a recombinant humanized IgG1 monoclonal antibody with two kappa light chains, two heavy chains and N-linked glycosylation on the heavy chains.
Therefore, conventional CMS parameters such as melting point, residue on ignition, specific rotation and generic small-molecule assay limits are not appropriate universal specifications for this API.
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology customers seeking Vedolizumab API for biological drug development, formulation and regulated manufacturing applications.
Our approach focuses on:
Swapnroop supports customers looking for Vedolizumab API Manufacturer and Supplier in India for pharmaceutical and biotechnology applications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |