Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Trastuzumab for pharmaceutical development, biotechnology applications and regulated pharmaceutical manufacturing. Trastuzumab is a recombinant humanized monoclonal antibody of the IgG1 kappa class that specifically targets the human epidermal growth factor receptor 2 (HER2).
Trastuzumab is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. It binds to the extracellular domain of HER2 and is used as an anti-HER2 therapeutic in oncology.
Trastuzumab is a complex recombinant protein rather than a conventional small-molecule API. It has a molecular mass of approximately 148 kDa in its glycosylated form. The theoretical nonglycosylated molecular mass is approximately 145.5 kDa.
The substance is identified by CAS No. 180288-69-1, molecular formula C6470H10012N1726O2013S42, and theoretical molecular weight approximately 145,531.5 Da.
Trastuzumab is used in pharmaceutical products for HER2-positive malignancies, including applications involving:
Swapnroop Drugs & Pharmaceuticals provides Trastuzumab manufacturing and supply support for biotechnology and pharmaceutical customers requiring recombinant monoclonal antibody material.
As a Trastuzumab API manufacturer and supplier in India, Swapnroop focuses on controlled biopharmaceutical manufacturing, product characterization, quality documentation and supply requirements appropriate for biologic products.
Trastuzumab drug substance and finished formulations require controlled temperature and handling conditions appropriate for monoclonal antibody products.
For the established lyophilized 150 mg finished-product presentation, the product is stored under refrigerated conditions, and the reconstituted solution should be handled according to the applicable validated product procedure.
Typical documentation for a recombinant monoclonal antibody may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology customers seeking reliable Trastuzumab API manufacturing and supply. The company focuses on biologic quality, controlled manufacturing processes, appropriate analytical characterization and documentation for pharmaceutical applications.
| 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) | 1% |