Telitacicept, also known as RC18, is a recombinant human TACI-Fc fusion protein designed to inhibit the B-cell activating factors BAFF/BLyS and APRIL. It combines the extracellular ligand-binding domain of human transmembrane activator and CAML interactor (TACI/TNFRSF13B) with the Fc region of human IgG1.
Telitacicept is a biologic immunomodulator developed by RemeGen. It has been approved in China and is being investigated internationally for B-cell-mediated autoimmune diseases. EMA documentation includes development programs for systemic lupus erythematosus (SLE) and myasthenia gravis.
Telitacicept is a dimeric recombinant fusion protein consisting of two identical TACI-Fc chains. Each protein chain contains 333 amino acids, while the mature biologic has an estimated average molecular weight of approximately 75.4 kDa. FDA GSRS lists the molecular formula as an estimated C3318H5118N914O1008S44.
The molecule contains N-linked glycosylation at Asn183 on each chain and multiple intrachain and interchain disulfide bonds characteristic of the fusion-protein structure.
FDA GSRS confirms the CAS, UNII, IgG1 fusion-protein classification, 75.4 kDa estimated average molecular weight and protein sequence.
Telitacicept inhibits signaling mediated by BAFF/BLyS and APRIL, two important regulators of B-cell survival and differentiation. It is therefore being developed for diseases in which abnormal B-cell activity contributes to pathogenesis.
Current regulatory development includes:
EMA has an active paediatric investigation plan for telitacicept in myasthenia gravis, with subcutaneous administration and both powder-for-solution and solution-for-injection presentations.
As a recombinant fusion protein, Telitacicept requires biologic-specific analytical characterization. Suitable quality-control testing can include:
Publicly available research-grade Telitacicept material is reported at approximately 75.36 kDa, with purity values around 99.3%, while individual lots may report higher values. These are commercial/research measurements rather than universal regulatory release specifications.
Swapnroop supports pharmaceutical and biologic API requirements with quality-focused analytical testing, technical documentation and customer-specific specifications.
Telitacicept can be supported with appropriate biologic characterization, analytical documentation and batch-specific quality information according to the intended application.
Telitacicept should be stored under controlled conditions appropriate for a recombinant protein. The exact storage temperature, formulation buffer and shelf-life should be determined from the applicable stability program and batch specification.
Research-grade material is commonly supplied as a solid/lyophilized protein or formulated solution, with lot-specific storage and reconstitution instructions.
Depending on the intended pharmaceutical application, documentation may include:
Swapnroop focuses on quality-oriented pharmaceutical and biologic API solutions supported by analytical testing and technical documentation. Telitacicept can be supported according to agreed specifications and the requirements of pharmaceutical development or manufacturing programs.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 99.0% |