Description

Agalsidase Beta is a recombinant form of the human enzyme α-galactosidase A, produced using mammalian cell culture technology. This therapeutic protein is critical for the treatment of Fabry disease, a rare genetic lysosomal storage disorder, by catalyzing the hydrolysis of globotriaosylceramide. It is essential for pharmaceutical manufacturers, biotechnology companies, and clinical research organizations involved in developing and producing enzyme replacement therapies. Our supply of Agalsidase Beta CAS NO 104138-64-9 is characterized by high purity and stringent quality control to meet the exacting demands of biopharmaceutical production.

Application

• Enzyme Replacement Therapy (ERT): Primary active pharmaceutical ingredient (API) in formulations for the treatment of Fabry disease.
• Biopharmaceutical Manufacturing: Used in the fill-finish process for producing sterile, lyophilized drug products.
• Clinical Research: Serves as a reference standard or investigational product in clinical trials for Fabry disease and related disorders.
• Biochemical Research: Utilized in in-vitro studies to understand glycosphingolipid metabolism and lysosomal function.
• Diagnostic Development: Potential use as a component in diagnostic kits or assays for enzyme activity measurement.

Basic Information

Product Name	Agalsidase Beta
CAS No.	104138-64-9
Molecular Formula	C2540H3868N672O734S20
Molecular Weight	Approx. 56,000 Da (monomer)
Synonyms	α-Galactosidase A (recombinant human); Fabrazyme (brand name); Recombinant human α-Gal A; Agalsidase-β; r-hαGAL; GLA; Melibiase; 1,4-α-D-Galactoside galactohydrolase (recombinant); CERLON
EINECS	Contact for details

Quality Control

Our Agalsidase Beta is manufactured and tested under strict quality systems to ensure it meets the rigorous standards for biopharmaceutical actives. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing critical quality attributes such as purity, potency, and impurity profiles. We adhere to relevant cGMP (current Good Manufacturing Practice) guidelines and support compliance with major pharmacopoeial standards. Certificates of Analysis are available upon request to support your regulatory and quality assurance processes.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Once reconstituted, the solution should be used immediately or stored as directed by the specific product protocol. This product is hygroscopic (moisture-sensitive) and must be protected from humidity during handling.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or cake
Identification (SDS-PAGE/Western Blot)	Complies
Purity (SEC-HPLC)	≥ 98.0 %
Protein Content	≥ 95.0 % (by UV)
Specific Activity	Contact for details
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg
Sterility (Membrane Filtration)	Sterile
Moisture Content (Karl Fischer)	≤ 3.0 %

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