Description

Rilonacept is a recombinant fusion protein designed to inhibit interleukin-1 signaling. This targeted biologic is critical for the treatment of rare autoinflammatory diseases, offering a specific mechanism of action to control systemic inflammation. It is primarily utilized by pharmaceutical manufacturers and research institutions focused on developing and producing advanced therapies for cryopyrin-associated periodic syndromes (CAPS) and related disorders.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active pharmaceutical ingredient in biologic drug formulations for autoinflammatory conditions.
• Therapeutic Agent for CAPS: Manufacture of therapeutics for Cryopyrin-Associated Periodic Syndromes, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
• Clinical Research & Development: Serves as a key reference standard and investigational material in preclinical and clinical studies targeting IL-1 mediated pathways.
• Biologic Drug Substance: Used in the fill-finish process for producing lyophilized (freeze-dried) powder for reconstitution or other sterile dosage forms.
• Biosimilar Development: Critical reference material for companies developing biosimilar versions of the innovator biologic product.

Basic Information

Product Name	Rilonacept
CAS No.	501081-76-1
Molecular Formula	C3320H5188N922O1002S44
Molecular Weight	~ 148 kDa
Synonyms	Interleukin-1 Trap; IL-1 Trap; IL1 Trap; ARCALYST® (Brand Name); rilonacept; Recombinant Fusion Protein; IL-1 Receptor Accessory Protein and IL-1 Receptor Type I Fc Fusion Protein; Cryopyrin-Associated Periodic Syndrome Therapeutic
EINECS	Contact for details

Quality Control

Our Rilonacept is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting stringent specifications for biologic drug substances. Certificates of Analysis (COA) are provided, detailing results from tests including HPLC purity, SDS-PAGE, peptide mapping, endotoxin levels, and biological activity assays.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This product is hygroscopic (moisture-sensitive). For long-term storage, keep desiccated. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Purity (SDS-PAGE, reduced & non-reduced)	≥ 95.0%
Assay (HPLC-SEC)	90.0% - 110.0% of label claim
Protein Content (UV)	As per COA
Biological Activity (Cell-based assay)	Meets acceptance criteria
Endotoxin	< 10 EU/mg
Residual Moisture (KF)	< 3.0%

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