Description

Pegloticase is a recombinant uricase enzyme used as a therapeutic protein for the treatment of chronic gout in adult patients refractory to conventional therapy. Its primary function is to catalyze the oxidation of uric acid into allantoin, a more soluble and readily excretable metabolite, thereby rapidly and significantly reducing serum uric acid levels. This product is essential for pharmaceutical manufacturers, biotechnology companies, and research institutions engaged in the development and production of advanced biologic therapies, particularly for metabolic and inflammatory disorders.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in biologic drug formulations for the treatment of refractory chronic gout.
• Biopharmaceutical Research: Used as a reference standard or tool compound in metabolic disorder research, enzymology studies, and pharmacokinetic/pharmacodynamic modeling.
• Drug Delivery System Development: Investigated in studies focusing on protein stabilization, pegylation technologies, and enhancing the therapeutic half-life of biologic agents.
• Clinical Trial Material (CTM): Supplied as a critical raw material for the manufacture of clinical supplies in Phase I-III trials for new biologic entities targeting hyperuricemia.
• Biosimilar Development: Serves as a key material for companies developing biosimilar versions of uricase-based therapeutics.

Basic Information

Product Name	Pegloticase
CAS No.	885051-90-1
Molecular Formula	Contact for details
Molecular Weight	Approx. 540 kDa (Pegylated tetramer)
Synonyms	Pegylated Recombinant Uricase; Uricase-PEG 20; Pegloticase Krystexxa; Polyethylene Glycol-conjugated Uricase; Recombinant Mammalian Urate Oxidase; PEG-Uricase; Rasburicase PEGylated; [mammalian urate oxidase]-PEG
EINECS	Contact for details

Quality Control

Our Pegloticase is manufactured and controlled under a quality management system. Each batch undergoes rigorous analytical testing to ensure identity, purity, potency, and safety, meeting high standards for biologic active substances. Certificates of Analysis (COA) providing detailed results for critical quality attributes such as protein content, enzymatic activity, purity by SE-HPLC, and endotoxin levels are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at -20°C or below. For long-term storage, maintain at -70°C or lower. This product is hygroscopic (moisture-sensitive). Avoid repeated freeze-thaw cycles. Thaw under controlled conditions (e.g., 2-8°C) and use immediately upon reconstitution according to protocol.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/Activity)	Conforms to reference standard
Protein Content (UV)	≥ 90%
Purity (SE-HPLC)	≥ 95.0% (Main Monomeric Peak)
Specific Activity	Contact for details
Endotoxin (LAL)	< 10 EU/mg
Residual Moisture (KF)	< 3.0%
Sterility (Membrane Filtration)	Sterile

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