Description

Guselkumab CAS NO 1350289-85-8 is a high-purity, human monoclonal antibody specifically designed to target the p19 subunit of interleukin-23 (IL-23). This targeted biological agent is critical for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis. It is primarily required by pharmaceutical manufacturers, biotechnology research organizations, and clinical development facilities engaged in the production of advanced biologic therapeutics and biosimilars.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of biologic drugs targeting IL-23-mediated autoimmune conditions.
• Reference Standard in quality control laboratories for the analysis and validation of commercial Guselkumab batches.
• Research Reagent in immunology and dermatology research to study the IL-23/Th17 pathway and its role in inflammatory diseases.
• Biosimilar Development as a key comparator for structural, functional, and bioanalytical characterization studies.
• Pre-clinical and Clinical Trial Material for investigative new drug (IND) applications and phase I-III clinical studies.

Basic Information

Product Name	Guselkumab
CAS No.	1350289-85-8
Molecular Formula	Contact for details
Molecular Weight	Approx. 144 kDa
Synonyms	CNTO 1959; Anti-IL-23 p19 monoclonal antibody; IL23p19 mAb; Tremfya (brand name); Guselkumab Injection; Guselkumab (recombinant); Human anti-IL23 monoclonal antibody IgG1λ
EINECS	Contact for details

Quality Control

Our Guselkumab is manufactured and tested under stringent quality systems. Each batch is characterized to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. Comprehensive testing includes assays for purity (SEC-HPLC, CE-SDS), biological activity (cell-based bioassay), and characterization of post-translational modifications. A Certificate of Analysis (COA) detailing all release specifications is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Avoid repeated freeze-thaw cycles. This product is hygroscopic (moisture-sensitive) and should be handled under controlled conditions to maintain integrity.

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
Protein Content (A280)	95.0% - 105.0% of label claim
Biological Activity (Cell-based Assay)	EC50 within defined range of reference
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.