Description

Romosozumab is a humanized monoclonal antibody designed as an anabolic agent for the treatment of osteoporosis. It functions by binding to and inhibiting sclerostin, a key regulator of bone metabolism, thereby promoting bone formation and reducing bone resorption. This innovative therapeutic is primarily utilized in the pharmaceutical and biotechnology sectors for the development of advanced treatments for postmenopausal women with osteoporosis at high risk for fracture.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in biologic drug formulations for osteoporosis.
• Clinical Research & Development: Serves as a critical reference standard and investigational material in preclinical and clinical studies for bone-related disorders.
• Biopharmaceutical Manufacturing: Used in the production and fill-finish processes of biologic drugs under Good Manufacturing Practice (GMP) conditions.
• Biochemical Research: Employed in laboratory research to study the Wnt signaling pathway, bone biology, and mechanisms of sclerostin inhibition.
• Therapeutic Antibody Development: Acts as a model compound for the development and characterization of other monoclonal antibody-based therapies.
• Quality Control & Analytical Testing: Used as a certified reference material for assay validation, potency testing, and impurity profiling in quality control laboratories.

Basic Information

Product Name	Romosozumab
CAS No.	909395-70-6
Molecular Formula	C6472H10028N1740O2010S46
Molecular Weight	Approx. 146 kDa
Synonyms	EVENITY (trade name); AMG 785; Anti-sclerostin monoclonal antibody; Romosozumab-aqqg; Sclerostin Inhibitor AMG 785; Humanized anti-sclerostin IgG2 monoclonal antibody; CDR-identified antibody hPAP(1-3)-3
EINECS	Contact for details

Quality Control

Our Romosozumab is manufactured and controlled under a quality management system. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting stringent specifications for biopharmaceutical use. Certificates of Analysis (COA) are provided, detailing results for critical quality attributes including purity by SE-HPLC, potency in a cell-based assay, host cell protein levels, and endotoxin content.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -80°C. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions or with desiccant.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spectrometry)	Conforms
Purity (SE-HPLC)	≥ 95.0% Monomer
Assay (Potency)	90.0% - 110.0% of label claim
Protein Content (A280)	90.0% - 110.0% of theoretical
Host Cell Proteins (HCP)	≤ 100 ppm
Endotoxin	< 1.0 EU/mg
pH	5.5 - 6.5 (for solution)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.