Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Tositumomab API manufacturer and supplier in India, supporting qualified pharmaceutical, biotechnology, research, and oncology-related requirements for monoclonal antibody drug substances.
Tositumomab is a recombinant/biological murine IgG2a lambda monoclonal antibody directed against the CD20 antigen expressed on normal and malignant B lymphocytes. It was the antibody component of the Bexxar (tositumomab and iodine I-131 tositumomab) radioimmunotherapy regimen developed for B-cell non-Hodgkin lymphoma. The FDA labeling describes tositumomab as a murine IgG2a lambda monoclonal antibody with an approximate molecular weight of 150 kDa.
Tositumomab is identified in NCBI's drug information as CAS 208921-02-2. It is a biologic monoclonal antibody rather than a conventional low-molecular-weight chemical API.
Tositumomab is an intact murine IgG2a lambda antibody directed against CD20. The antibody is composed of two murine gamma-2a heavy chains and two lambda light chains. The reported antibody structure contains approximately 451 amino acids in each heavy chain and 220 amino acids in each light chain, with an overall molecular mass of approximately 150 kDa.
The antibody binds CD20 on B lymphocytes and was used as the targeting component of iodine-131 tositumomab radioimmunotherapy. The FDA approved the Bexxar regimen in 2003 for certain patients with CD20-positive follicular non-Hodgkin lymphoma.
Tositumomab was used as the antibody component of a targeted radioimmunotherapy regimen. By binding to CD20, the antibody targets B lymphocytes, allowing the radiolabeled form, iodine I-131 tositumomab, to deliver therapeutic radiation to CD20-positive B-cell malignancies.
The Bexxar regimen was approved for patients with CD20-positive follicular non-Hodgkin lymphoma, including patients whose disease was refractory to rituximab and had relapsed following chemotherapy.
Swapnroop supports qualified customers seeking Tositumomab drug substance / monoclonal antibody API for research, analytical, development, and qualified pharmaceutical requirements.
Because Tositumomab is a monoclonal antibody, its quality attributes are fundamentally different from those of conventional synthetic APIs. Appropriate characterization may include antibody identity, purity, aggregation, protein concentration, charge variants, molecular integrity, binding activity, and other biologic critical quality attributes.
The historical Bexxar formulation supplied tositumomab as a sterile, pyrogen-free, clear-to-opalescent, colorless-to-slightly-yellow, preservative-free liquid concentrate. The antibody drug product was supplied at a nominal concentration of 14 mg/mL, with a formulation pH of approximately 7.2.
These are historical finished-product values, not universal bulk drug-substance specifications for Tositumomab.
Depending on the applicable supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Tositumomab drug-substance/API supply support for qualified pharmaceutical, biotechnology, research, and development requirements.
| 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) | 7.2 |