Description

Alglucerase is a modified form of the human enzyme glucocerebrosidase, produced using recombinant DNA technology for therapeutic use. This product is critical for enzyme replacement therapy, addressing a specific metabolic deficiency. It is primarily required by the biopharmaceutical industry for the formulation of treatments for Gaucher disease, a rare genetic disorder.

Application

• Enzyme Replacement Therapy (ERT): The primary and most significant application is as the active pharmaceutical ingredient (API) in treatments for Type 1 Gaucher disease.
• Biopharmaceutical Formulation: Used in the development and commercial manufacturing of injectable drug products designed for long-term management of lysosomal storage disorders.
• Clinical Research: Serves as a reference standard or investigational material in preclinical and clinical studies for metabolic diseases.
• Specialty Pharmaceutical Manufacturing: Employed by contract development and manufacturing organizations (CDMOs) specializing in parenteral and biologic drugs.

Basic Information

Product Name	Alglucerase
CAS No.	143003-46-7
Molecular Formula	Contact for details
Molecular Weight	~60 kDa (Approximate, varies with glycosylation)
Synonyms	Glucocerebrosidase (modified); Ceredase (brand name); Alglucerase Injection; Imiglucerase precursor; β-glucocerebrosidase (modified); Macrophage-targeted glucocerebrosidase; Recombinant glucocerebrosidase (modified); Lysosomal enzyme (modified)
EINECS	Contact for details

Quality Control

Our Alglucerase is manufactured and controlled under a quality management system designed for active pharmaceutical ingredients. Each batch undergoes rigorous analytical testing including purity assay, activity determination, and impurity profiling to ensure it meets stringent specifications for therapeutic use. A comprehensive Certificate of Analysis (COA) documenting identity, purity, potency, and safety is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at -20°C or below. This product is hygroscopic (moisture-sensitive). Allow to equilibrate to room temperature in the unopened container before use to prevent condensation. For long-term storage, maintain continuous frozen conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/MS)	Conforms to reference standard
Assay (Enzymatic Activity)	≥ XX U/mg (Contact for specific grade)
Purity (SDS-PAGE/HPLC)	≥ 95.0%
Protein Content	≥ XX % (Biuret/Lowry)
Endotoxin	< XX EU/mg
Bioburden	To comply with Ph. Eur. 2.6.12
Moisture (KF)	≤ 5.0%

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