Description

Teprotumumab is a fully human monoclonal antibody specifically designed to inhibit the insulin-like growth factor-1 receptor (IGF-1R). This targeted biologic agent is of critical importance in the treatment of active thyroid eye disease (TED), where it addresses the underlying inflammatory pathology. Pharmaceutical manufacturers and advanced biopharmaceutical research organizations require this high-purity active pharmaceutical ingredient (API) for the formulation of innovative therapeutics.

Application

• Primary Therapeutic Use: Formulation of the biologic drug for the treatment of moderate-to-severe Thyroid Eye Disease (TED), also known as Graves' ophthalmopathy.
• Biopharmaceutical Research: Serves as a critical reference standard and active material in R&D focused on IGF-1R pathway inhibition.
• Drug Product Manufacturing: Used as the core active pharmaceutical ingredient (API) in the commercial-scale production of finished biologic injectables.
• Clinical Trial Material: Supply of GMP-grade material for use in Phase I-IV clinical studies investigating new indications or formulations.
• Biosimilar Development: Acts as the reference product for analytical characterization and comparability studies in biosimilar development programs.

Basic Information

Product Name	Teprotumumab
CAS No.	1036734-93-6
Molecular Formula	C6462H9996N1732O2010S46
Molecular Weight	~145 kDa
Synonyms	RV 001; TEP-001; R 1507; RO 4858696; Anti-IGF-1R Recombinant Monoclonal Antibody; IGF-1R Inhibitor R1507; Teprotumumab-trbw; Tepezza (Brand Name)
EINECS	Contact for details

Quality Control

Our Teprotumumab is manufactured under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for a monoclonal antibody API. Certificates of Analysis (COA) detailing specifications such as purity by SEC-HPLC, host cell protein levels, endotoxin content, and biological activity are provided. We support compliance with cGMP, ICH Q7, and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -70°C. Avoid repeated freeze-thaw cycles. Under these recommended conditions, the product remains stable for the duration indicated on the certificate of analysis.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (SEC-HPLC)	Conforms to reference standard
Purity (Monomer by SEC-HPLC)	≥ 98.0%
Protein Content (A280)	As per COA
Potency (Cell-Based Bioassay)	As per COA
Host Cell Proteins (HCP)	< 100 ppm
Endotoxin	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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