Tarlatamab is a recombinant bispecific T-cell engager (BiTE) designed to target delta-like ligand 3 (DLL3) on tumor cells and CD3 on T cells. By simultaneously engaging DLL3-expressing tumor cells and T cells, tarlatamab promotes T-cell activation and redirected tumor-cell lysis.
Tarlatamab-dlle is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. The molecule consists of 982 amino acids and has a molecular weight of approximately 105 kDa.
Tarlatamab is a complex protein therapeutic rather than a conventional small-molecule API. It contains two single-chain variable-fragment binding domains directed against DLL3 and CD3, together with a silenced Fc immunoglobulin domain that contributes to extended serum half-life.
CAS Number: 2307488-83-9
Molecular Weight: approximately 105 kDa
Amino Acids: 982
Molecule Type: Bispecific T-cell engager
Target: DLL3 and CD3
Expression System: Chinese hamster ovary (CHO) cells
Development Code: AMG 757
Brand: IMDELLTRA
PubChem identifies CAS 2307488-83-9 for tarlatamab, while FDA regulatory documentation identifies the approved active ingredient as tarlatamab-dlle.
Tarlatamab binds simultaneously to DLL3 expressed on the surface of tumor cells and CD3 expressed on T cells. This physical engagement redirects T cells toward DLL3-positive tumor cells.
The resulting T-cell activation promotes release of inflammatory cytokines and cytotoxic proteins, leading to targeted lysis of DLL3-expressing tumor cells.
Tarlatamab-dlle is an oncology biologic used for adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. The FDA approved tarlatamab-dlle under the accelerated-approval pathway in May 2024.
Its therapeutic activity is associated with the high expression of DLL3 observed in small cell lung cancer and the ability of the bispecific molecule to recruit T cells against DLL3-expressing malignant cells.
As a recombinant bispecific protein therapeutic, tarlatamab requires biologics-specific analytical characterization rather than conventional small-molecule API testing.
Relevant quality attributes may include:
FDA's chemistry review concluded that the manufacturing process for IMDELLTRA was adequately controlled and produced a product that was pure and potent.
Swapnroop Drugs and Pharmaceuticals is an India-based pharmaceutical manufacturing organization supporting pharmaceutical and biopharmaceutical requirements with quality-focused manufacturing and documentation.
Tarlatamab is a highly specialized recombinant bispecific protein and therefore requires biologics-specific manufacturing controls, characterization, impurity assessment, potency testing, and validated storage and transportation conditions.
The exact drug-substance specification should be established according to the applicable regulatory dossier, validated analytical methods, and customer requirements.
Tarlatamab-dlle is supplied commercially as a sterile, preservative-free, white to slightly yellow lyophilized powder for reconstitution. FDA describes single-dose vial presentations containing 1 mg and 10 mg of tarlatamab-dlle.
For drug-substance supply, packaging, storage temperature, shipping conditions, retest period, and shelf-life should follow validated stability data and the applicable approved specification.
Documentation for Tarlatamab API or drug-substance projects may include:
Tarlatamab is a recombinant bispecific T-cell engager that targets DLL3 on tumor cells and CD3 on T cells. It consists of 982 amino acids and has an approximate molecular weight of 105 kDa. It is produced using recombinant DNA technology in CHO cells and is used as an oncology biologic for extensive-stage small cell lung cancer in the approved indication.
Because tarlatamab is a complex protein therapeutic, its quality assessment relies on identity, purity, structural characterization, aggregate control, glycosylation, process-related impurity testing, and biological potency rather than conventional small-molecule API specifications.
Swapnroop Drugs and Pharmaceuticals supports qualified pharmaceutical and biopharmaceutical customers with quality-focused manufacturing and documentation.
| 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% |