Talquetamab is a recombinant bispecific T-cell-engaging monoclonal antibody designed to target G protein-coupled receptor class C group 5 member D (GPRC5D) on multiple myeloma cells and CD3 on T cells. It is marketed as TALVEY (talquetamab-tgvs) and is administered by subcutaneous injection. FDA identifies the substance as a humanized IgG4 bispecific antibody and gives the CAS name as 2226212-40-2.
Talquetamab is a biologic oncology API rather than a conventional small-molecule active pharmaceutical ingredient. Its complex molecular architecture consists of two antibody arms directed against different targets. The approximate molecular weight is 147 kDa, according to the EMA assessment report.
Talquetamab is a humanized IgG4 bispecific antibody with one arm recognizing GPRC5D and the other recognizing CD3. PubChem identifies the compound under CAS 2226212-40-2, development code JNJ-64407564, and FDA UNII 4W3KFI3TN3.
Because Talquetamab is a recombinant protein, it does not have the type of simple molecular formula, melting point or small-molecule physicochemical specification normally used for conventional APIs. Its quality is characterized through protein identity, purity, aggregation, charge variants, glycosylation, potency and other critical quality attributes.
Talquetamab simultaneously binds GPRC5D on malignant plasma cells and CD3 on T cells. This brings T cells into close proximity with GPRC5D-expressing multiple myeloma cells, resulting in T-cell activation and cytotoxic destruction of the target cells.
The mechanism therefore represents a T-cell redirection strategy in which the antibody acts as a molecular bridge between immune effector cells and malignant plasma cells.
Talquetamab is an oncology biologic used for relapsed and refractory multiple myeloma. The EMA indication covers adults who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, with disease progression on the last therapy.
In the United States, TALVEY received accelerated approval for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The EMA assessment describes Talquetamab as having an approximate molecular weight of 147 kDa. As an IgG4-based bispecific antibody, it is expected to undergo catabolic degradation through pathways involved in the turnover of endogenous immunoglobulins.
The marketed drug product is supplied as a sterile solution for subcutaneous injection at 2 mg/mL and 40 mg/mL strengths.
Talquetamab drug substance requires biologics-specific analytical characterization. Appropriate quality attributes may include:
FDA confirms that a T-cell activation assay is used to measure Talquetamab potency. The numerical acceptance criteria in the public FDA CMC review are redacted.
Talquetamab is manufactured as a recombinant antibody using biotechnology-based production and purification processes. Manufacturing of such a bispecific antibody requires careful control of the expression system, purification process, molecular assembly, product-related variants and biological activity.
The final drug substance must meet its registered biological-product specification before being used for finished pharmaceutical manufacturing.
Talquetamab drug substance should be packaged in suitable pharmaceutical-grade containers and stored according to validated stability data and the registered drug-substance specification.
For the finished TALVEY product, FDA labeling specifies a sterile solution for subcutaneous injection, while the FDA CMC review reports an 18-month finished-product shelf life at 2–8°C protected from light. This finished-product condition should not automatically be represented as the API drug-substance storage specification.
A pharmaceutical-grade Talquetamab drug-substance package may include a Certificate of Analysis, biological specification, analytical methods, potency data, impurity profile, stability information, batch documentation and applicable regulatory documentation.
A qualified Talquetamab manufacturer in India should maintain strong biologics manufacturing controls and validated analytical procedures covering antibody identity, purity, aggregation, charge variants, glycosylation and biological potency. Because Talquetamab is a bispecific T-cell engager, control of target-binding and functional activity is particularly important for consistent product quality.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |