Tisotumab Vedotin API is an advanced antibody-drug conjugate (ADC) and oncology biologic designed to selectively target Tissue Factor (TF) expressed on cancer cells. It consists of a human IgG1-kappa monoclonal antibody conjugated with the cytotoxic payload monomethyl auristatin E (MMAE) through a protease-cleavable valine-citrulline (vc) linker. Tisotumab Vedotin is developed for targeted cancer therapy and is marketed under the brand name Tivdak. (EMA)
Tisotumab Vedotin, also known as Tisotumab Vedotin-tftv and previously designated HuMax-TF-ADC, is a Tissue Factor-directed antibody-drug conjugate. The antibody component binds to Tissue Factor on the surface of target cells and facilitates internalization of the ADC. Following internalization, the protease-cleavable linker enables release of MMAE, which disrupts microtubule function and contributes to cell-cycle arrest and cancer-cell death.
Tisotumab Vedotin has an approximate molecular weight of 153 kDa and an average drug-to-antibody ratio (DAR) of approximately 4 MMAE molecules per antibody. (FDA)
Tisotumab Vedotin is a complex biological drug substance rather than a conventional small-molecule pharmaceutical API. Its characterization therefore involves antibody identity, purity, conjugation characteristics, drug loading, potency and other biologic quality attributes.
Product Name: Tisotumab Vedotin
CAS Number: 1418731-10-8
Development Code: HuMax-TF-ADC
Molecular Type: Antibody-Drug Conjugate (ADC)
Antibody: Human IgG1-kappa monoclonal antibody
Target: Tissue Factor (TF)
Cytotoxic Payload: Monomethyl Auristatin E (MMAE)
Linker: Valine-Citrulline (vc) protease-cleavable linker
Average Drug-to-Antibody Ratio: Approximately 4
Approximate Molecular Weight: 153 kDa
Therapeutic Area: Oncology
Pharmacological Class: Antibody-Drug Conjugate / Antineoplastic Agent
Tisotumab Vedotin combines targeted antibody recognition with cytotoxic drug delivery. The monoclonal antibody portion binds to Tissue Factor present on the surface of target cancer cells. The ADC-Tissue Factor complex is subsequently internalized by the cell.
After internalization, the valine-citrulline linker is cleaved by intracellular proteases, releasing MMAE. MMAE binds to tubulin and disrupts microtubule networks, resulting in inhibition of cell division and ultimately cancer-cell death.
This targeted ADC mechanism enables the delivery of a potent cytotoxic payload to Tissue Factor-expressing cells. (FDA)
Tisotumab Vedotin is primarily used in oncology and immuno-oncology drug development as a Tissue Factor-targeted antibody-drug conjugate.
Its pharmaceutical applications include:
Tisotumab Vedotin is approved for specific oncology indications in applicable jurisdictions. The approved indication should be confirmed against the regulatory requirements of the intended market.
Swapnroop Pharma offers Tisotumab Vedotin API for qualified pharmaceutical and biopharmaceutical requirements. As an advanced antibody-drug conjugate, Tisotumab Vedotin requires specialized characterization and quality evaluation appropriate for biologic drug substances.
Swapnroop supports pharmaceutical companies, biotechnology organizations, formulation developers and qualified buyers seeking oncology biologics and ADC-related pharmaceutical materials from India.
Product specifications, analytical documentation and technical information can be provided according to the applicable product grade and customer requirements.
Tisotumab Vedotin is available for qualified bulk pharmaceutical and biopharmaceutical requirements, subject to product availability and applicable commercial conditions.
Bulk supply can be supported with relevant product documentation, including Certificate of Analysis, Product Specification, Safety Data Sheet and applicable technical or regulatory documentation.
Packaging and transportation conditions should be established according to the validated stability requirements of the biological drug substance.
As an antibody-drug conjugate, Tisotumab Vedotin is evaluated using biologic-specific analytical approaches. Important quality attributes can include:
The actual acceptance criteria should be based on the manufacturer's approved specification and validated analytical methods rather than generic small-molecule API limits.
Tisotumab Vedotin is a protein-based antibody-drug conjugate and should be handled under controlled conditions appropriate for biological drug substances.
The approved finished product is supplied as a 40 mg/vial lyophilized powder for intravenous administration. After reconstitution with 4 mL of Sterile Water for Injection, the resulting concentration is 10 mg/mL. The finished product has a reported pH of 6.0 and is stored at 2°C–8°C under the approved product conditions. (FDA)
Storage conditions for bulk drug substance should always follow the actual manufacturer's validated stability data and approved specification.
Depending on product grade and customer requirements, documentation may include:
For pharmaceutical and biotechnology companies seeking Tisotumab Vedotin API in India, Swapnroop Pharma provides sourcing and supply support for qualified oncology and biopharmaceutical requirements.
Contact Swapnroop Pharma for Tisotumab Vedotin API availability, product specifications, analytical documentation, packaging and bulk requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |