Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Trastuzumab Emtansine for pharmaceutical and biopharmaceutical applications. Trastuzumab emtansine, also known as ado-trastuzumab emtansine or T-DM1, is an antibody-drug conjugate (ADC) consisting of the HER2-targeting monoclonal antibody trastuzumab covalently linked to the cytotoxic maytansinoid derivative DM1 through the non-cleavable MCC linker.
Trastuzumab emtansine is a complex biologic drug substance rather than a conventional small-molecule API. FDA characterization reports a theoretical molecular mass of approximately 148,781 Da with an average DM1-to-trastuzumab ratio of 3.5.
Trastuzumab emtansine is designed to selectively target HER2-expressing cancer cells. The trastuzumab component binds HER2, while the DM1 payload inhibits tubulin polymerization after cellular internalization. The drug substance is manufactured as a recombinant antibody-drug conjugate.
The FDA identifies the substance as trastuzumab-MCC-DM1, with the synonyms T-DM1 and ado-trastuzumab emtansine. The FDA substance record identifies UNII SE2KH7T06F and CAS 1018448-65-1.
The EMA describes trastuzumab emtansine as trastuzumab, a humanized IgG1 monoclonal antibody produced using CHO cell culture, covalently linked to DM1 through the stable MCC thioether linker.
Trastuzumab emtansine is used in pharmaceutical products for HER2-positive breast cancer, including:
The currently authorized Kadcyla product contains trastuzumab emtansine and is supplied as a sterile powder for concentrate for intravenous infusion.
Swapnroop Drugs & Pharmaceuticals provides manufacturing and supply support for Trastuzumab Emtansine API, serving pharmaceutical and biopharmaceutical customers requiring complex antibody-drug conjugate materials.
As a Trastuzumab Emtansine API manufacturer and supplier in India, Swapnroop focuses on controlled biologic manufacturing, ADC characterization, quality documentation and supply requirements applicable to complex biologic drug substances.
Trastuzumab emtansine drug substance requires controlled temperature storage and protection from conditions that may affect the stability of the antibody-drug conjugate.
Regulatory assessment information reports storage of the drug substance at approximately −15°C to −25°C or colder, with commercial drug-substance stability supporting storage around −20°C.
For the finished product, Kadcyla is supplied as 100 mg and 160 mg single-use lyophilized vials. After reconstitution, the concentration is 20 mg/mL.
Typical documentation for an ADC biologic may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical and biotechnology customers requiring Trastuzumab Emtansine API with controlled manufacturing, appropriate biologic characterization and pharmaceutical documentation.
The company provides supply support for customers seeking a reliable Trastuzumab Emtansine API manufacturer and supplier in India.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |