Tafolecimab is a fully human immunoglobulin G2 (IgG2) monoclonal antibody and a PCSK9 inhibitor developed for lipid-lowering therapy. Also known by the development code IBI-306, Tafolecimab specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9), helping prevent PCSK9-mediated degradation of low-density lipoprotein receptors (LDLR) and thereby promoting clearance of LDL cholesterol from circulation.
Tafolecimab has CAS Number 2225109-03-3 and an approximate molecular weight of 145.34 kDa. It is classified as a human IgG2 monoclonal antibody.
Swapnroop provides pharmaceutical and biopharmaceutical API solutions, including support for Tafolecimab-related requirements subject to applicable manufacturing capabilities, specifications, documentation and regulatory requirements.
Tafolecimab, also designated IBI-306, is a human IgG2 monoclonal antibody directed against PCSK9. By binding PCSK9, Tafolecimab interferes with PCSK9-mediated internalization and degradation of LDL receptors on hepatocytes. Increased LDL receptor availability promotes the uptake and clearance of circulating LDL cholesterol.
Tafolecimab is associated with the cardiovascular and metabolic therapeutic area. Innovent's product portfolio identifies SINTBILO (tafolecimab) as a monoclonal antibody targeting PCSK9, with approved indications including primary hypercholesterolemia and mixed dyslipidemia.
Unlike conventional small-molecule APIs, Tafolecimab is a biological drug substance consisting of a recombinant monoclonal antibody. Therefore, parameters such as molecular weight, identity, purity, aggregation, charge variants and biological activity are more relevant to quality characterization than conventional small-molecule parameters such as melting point or residue on ignition.
Tafolecimab is reported as a human IgG2 monoclonal antibody with a molecular weight of approximately 145.34 kDa. Research-grade material is described as a liquid with a colorless to light-yellow appearance, although the final appearance and formulation should be established from the applicable drug-substance or drug-product specification.
Tafolecimab acts as a PCSK9 inhibitor. PCSK9 normally contributes to LDL receptor degradation. By binding PCSK9, Tafolecimab helps preserve LDL receptors on the cell surface, increasing LDL uptake and reducing circulating LDL-C levels.
Pharmaceutical applications associated with Tafolecimab include:
China's NMPA approved Tafolecimab injection in 2023 for adult patients with primary hypercholesterolemia and mixed dyslipidemia who do not achieve recommended LDL-C targets with moderate- or high-intensity statin therapy.
Because Tafolecimab is a monoclonal antibody, quality control should use analytical methods appropriate for biological products.
Typical characterization and quality-control parameters may include:
Acceptance criteria should be taken from the applicable approved specification and validated analytical methods. Numerical limits should not be added to the public page unless they are supported by the actual Tafolecimab specification or CoA.
Swapnroop provides pharmaceutical and biopharmaceutical product solutions for customers requiring quality-focused API and biological drug-substance support.
For Tafolecimab-related requirements, supply and documentation should be confirmed according to the applicable biological manufacturing capabilities, customer requirements and regulatory market.
Swapnroop's quality-focused approach can support requirements involving:
Contact Swapnroop for current Tafolecimab availability, technical specifications, documentation and commercial requirements.
Tafolecimab is a biological product and requires controlled handling and storage conditions appropriate to the specific formulation and manufacturing specification.
Storage conditions should be based on the approved product specification, stability data and applicable Certificate of Analysis.
For biological materials, appropriate temperature-controlled handling and transportation should be maintained throughout the supply chain where required.
Depending on the product stage and applicable regulatory requirements, documentation may include:
Swapnroop focuses on pharmaceutical and biopharmaceutical product requirements with emphasis on quality, analytical characterization and appropriate technical documentation.
Tafolecimab is a specialized anti-PCSK9 monoclonal antibody API/biological drug substance, making appropriate biological manufacturing and quality-control processes essential for pharmaceutical applications.
For Tafolecimab requirements, contact Swapnroop for technical information, specifications, documentation and bulk supply enquiries.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 90.0–110.0% |
| pH (1% Solution) | 5.0 ± 0.5 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.5% |