Loncastuximab Tesirine, also known as loncastuximab tesirine-lpyl and ADCT-402, is a CD19-directed antibody-drug conjugate (ADC) used in oncology. It combines a humanized IgG1 kappa monoclonal antibody with a pyrrolobenzodiazepine (PBD) cytotoxic payload through a protease-cleavable linker.
Loncastuximab Tesirine has the CAS Number 1879918-31-6 and an approximate molecular weight of 151 kDa. It is a complex biological drug conjugate consisting of an antibody, linker and cytotoxic payload.
Loncastuximab Tesirine targets CD19, a protein found on B-cell lineage cells. After binding to CD19, the antibody-drug conjugate is taken into the target cell. The linker is then cleaved, releasing the cytotoxic PBD payload.
The released payload interacts with DNA and forms DNA cross-links, which interfere with DNA replication and transcription and can lead to cancer-cell death. Loncastuximab Tesirine is marketed under the brand name ZYNLONTA and is administered by intravenous infusion.
Loncastuximab Tesirine binds to CD19 on malignant B cells and is internalized into the cell. Inside the cell, the protease-cleavable linker releases the PBD-based cytotoxic payload.
The released payload forms cross-links with DNA, interfering with DNA replication and transcription. This activity ultimately contributes to inhibition of cell growth and induction of cell death.
Loncastuximab Tesirine requires specialized analytical characterization because it is a complex antibody-drug conjugate. Suitable analytical methods may be used to evaluate identity, purity, antibody integrity, conjugation characteristics, drug-to-antibody ratio (DAR), aggregates and other product-quality attributes.
Quality control should be performed according to the applicable product specification and may include biological, chromatographic, spectroscopic and other validated analytical procedures.
Loncastuximab Tesirine should be stored under controlled conditions appropriate for biological pharmaceutical products. The product should be protected from excessive heat, light and contamination, and temperature excursions should be avoided. Specific storage and handling requirements should follow the applicable manufacturer specification and product documentation.
Loncastuximab Tesirine may be supplied for qualified pharmaceutical, biopharmaceutical, research and development applications, subject to applicable regulatory requirements. Product specifications, Certificate of Analysis, packaging configuration, technical documentation and storage requirements should be confirmed according to the intended application.
Swapproop Drugs and Pharmaceuticals supports the sourcing and supply of specialty pharmaceutical and biopharmaceutical products such as Loncastuximab Tesirine for qualified pharmaceutical and research requirements.
Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for Loncastuximab Tesirine.
Loncastuximab Tesirine has CAS Number 1879918-31-6, development code ADCT-402 and FDA UNII 7K5O7P6QIU. The conjugate has an approximate molecular weight of 151 kDa and contains an average of approximately 2.3 cytotoxic payload molecules per antibody molecule.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |