Description

Sarilumab is a high-purity, recombinant human monoclonal antibody designed to specifically target and inhibit the interleukin-6 (IL-6) receptor. This product is essential for pharmaceutical research and development, offering a critical tool for studying inflammatory pathways and autoimmune disease mechanisms. It is primarily required by biopharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in the development of targeted biologic therapies for conditions such as rheumatoid arthritis.

Application

• Primary active pharmaceutical ingredient (API) in the formulation of biologic drugs targeting IL-6 mediated diseases.
• Critical reference standard for bioanalytical method development and validation in pharmacokinetic/pharmacodynamic (PK/PD) studies.
• Essential reagent for in vitro and in vivo research models investigating the role of IL-6 signaling in autoimmune disorders and cytokine release syndrome.
• Key material for the development and quality control of biosimilar candidates to commercial Sarilumab products.
• Used in cell-based assays for screening and characterizing potential combination therapies.
• Vital component in stability studies and forced degradation studies to understand product profiles.

Basic Information

Product Name	Sarilumab
CAS No.	1189541-98-7
Molecular Formula	C38H57N9O9S2 (Note: This represents the peptide sequence of the complementary-determining region (CDR); full antibody structure is significantly larger and complex)
Molecular Weight	Approx. 150 kDa (Monoclonal Antibody)
Synonyms	REGN88; SAR153191; Anti-IL-6R monoclonal antibody; IL-6R inhibitor; Kevzara® (Brand Name); Immunoglobulin G1, anti-(human interleukin 6 receptor) (human REGN88 heavy chain), disulfide with human REGN88 light chain, dimer
EINECS	Contact for details

Quality Control

Our Sarilumab is manufactured under strict quality management systems. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines for biotechnological products. A Certificate of Analysis (COA) detailing specifications for purity (by SEC-HPLC and CE-SDS), biological activity (cell-based bioassay), endotoxin levels, and host cell protein/DNA content is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Reconstituted or liquid formulations should be stored at 2-8°C and used promptly. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled humidity conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS, Reduced)	Heavy Chain & Light Chain bands present, ≥ 95.0%
Assay (Protein Content)	90.0% - 110.0% of label claim
Biological Activity (Cell-based Assay)	EC50 within defined range of reference
Endotoxin	< 1.0 EU/mg
pH	6.0 - 7.0 (for solution)
Moisture Content (KFT)	≤ 3.0% (for lyophilized powder)

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