Description

Laronidase [Usan:Inn] CAS NO 210589-09-6 is a recombinant form of the human enzyme α-L-iduronidase, produced using recombinant DNA technology. This enzyme is critical for the hydrolysis of terminal α-L-iduronic acid residues in glycosaminoglycans, specifically dermatan sulfate and heparan sulfate. It is primarily required by the pharmaceutical and biotechnology sectors for the formulation of enzyme replacement therapies, specifically for the treatment of the lysosomal storage disorder Mucopolysaccharidosis I (MPS I), also known as Hurler, Hurler-Scheie, and Scheie syndromes.

Application

• Enzyme Replacement Therapy (ERT): The primary and most critical application is as the active pharmaceutical ingredient (API) in the treatment of Mucopolysaccharidosis I (MPS I).
• Pharmaceutical Formulation: Used in the development and commercial manufacturing of sterile, injectable biologic drug products.
• Biomedical Research: Serves as a key reagent in biochemical and pharmacological research focused on lysosomal storage diseases, enzyme kinetics, and glycosaminoglycan metabolism.
• Reference Standard: Utilized as a high-purity reference material in analytical laboratories for method development, validation, and quality control testing of related biopharmaceuticals.
• Clinical Trial Material: Supplied as a GMP-grade material for use in pre-clinical studies and clinical trials for novel therapies related to MPS I.

Basic Information

Product Name	Laronidase [Usan:Inn]
CAS No.	210589-09-6
Molecular Formula	C2536H3858N672O711S16
Molecular Weight	Approx. 83,000 Da (monomer)
Synonyms	α-L-iduronidase (recombinant human); Aldurazyme (brand name); Laronidase (INN, USAN); Recombinant human α-L-iduronidase; rhIDU; IDUA; EC 3.2.1.76; Mucopolysaccharidosis I therapeutic enzyme
EINECS	Contact for details

Quality Control

Our Laronidase is manufactured under strict cGMP (current Good Manufacturing Practice) conditions suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical characterization, including tests for identity, purity, potency, and safety, ensuring compliance with relevant pharmacopeial standards (e.g., USP monographs for biologics). A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), specific activity, protein content, endotoxin levels, and sterility is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized (freeze-dried) 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, dry conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (HPLC/Peptide Mapping)	Conforms to reference standard
Purity (SDS-PAGE, reduced)	≥ 95.0%
Purity (Size-Exclusion HPLC)	≥ 98.0% monomer
Specific Activity	Contact for details
Protein Content (UV Absorbance)	Contact for details
Endotoxins (LAL)	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile
pH	Specified range
Moisture Content (KF)	< 3.0% (for lyophilized form)

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