Description

Imiglucerase is a recombinant form of the human enzyme β-glucocerebrosidase, produced using recombinant DNA technology. This therapeutic enzyme is critical for the treatment of Gaucher disease, a genetic lysosomal storage disorder, by facilitating the breakdown of accumulated glucocerebroside. It is primarily utilized by the pharmaceutical and biotechnology industries for the formulation of life-saving enzyme replacement therapies. Our supply of Imiglucerase CAS NO 154248-97-2 is manufactured under stringent quality controls to ensure the highest standards of purity and biological activity for clinical applications.

Application

• Enzyme Replacement Therapy (ERT): The primary and most critical application is as the active pharmaceutical ingredient (API) in treatments for Type 1 Gaucher disease.
• Pharmaceutical Formulations: Used in the development and commercial production of lyophilized (freeze-dried) powder for reconstitution and intravenous infusion.
• Biomedical Research: Serves as a reference standard or reagent in biochemical research focused on lysosomal function, enzyme kinetics, and glycosphingolipid metabolism.
• Clinical Trial Material: Supplied as a critical component for preclinical studies and Phase I-III clinical trials investigating new therapeutic protocols or biosimilar development.
• Biosimilar Development: Acts as a key comparator for companies developing and validating biosimilar versions of this essential biologic.

Basic Information

Product Name	Imiglucerase
CAS No.	154248-97-2
Molecular Formula	C2542H3852N672O711S16
Molecular Weight	Approximately 60.5 kDa
Synonyms	β-Glucocerebrosidase (Recombinant); Cerezyme (Brand Name); Recombinant Glucosylceramidase; Alglucerase (Modified Form); β-D-Glucosyl-N-acylsphingosine Glucohydrolase (Recombinant); GCD; GBA (Recombinant); Ucerase; Imiglucerase alfa
EINECS	Contact for details

Quality Control

Our Imiglucerase is produced and tested to meet the exacting standards required for pharmaceutical active ingredients. Quality assurance adheres to current Good Manufacturing Practices (cGMP) and relevant ICH guidelines. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing critical quality attributes such as purity (by HPLC), specific activity, endotoxin levels, sterility, and identity. We ensure full traceability and compliance with global regulatory expectations for biologic therapeutics.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at 2-8°C. The reconstituted solution should be used immediately or stored as directed by the final product manufacturer. This product is hygroscopic (moisture-sensitive); protect from excessive humidity and store in a controlled environment.

Specification

Item	Specification
Appearance	White or off-white lyophilized cake or powder
Identification (HPLC/MS)	Conforms to reference standard
Purity (SDS-PAGE / SEC-HPLC)	≥ 98.0%
Specific Activity	Contact for details
Protein Content (UV)	Contact for details
Endotoxins (LAL)	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile
pH (in solution)	6.0 - 7.0
Moisture Content (KF)	< 3.0%

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