Description

Aducanumab is a human monoclonal antibody designed to target aggregated amyloid-beta for the treatment of Alzheimer's disease. Its development represents a significant advancement in addressing the underlying pathology of neurodegenerative conditions. This high-purity biological is critical for pharmaceutical research, clinical development, and advanced therapeutic manufacturing.

Application

• Pharmaceutical Active Ingredient: Primary use as the active pharmaceutical ingredient (API) in biologic formulations for Alzheimer's disease therapy.
• Clinical Research & Development: Essential for preclinical and clinical trials investigating amyloid-beta targeting and neuroprotective mechanisms.
• Reference Standard: Serves as a high-purity analytical standard for bioassay validation, quality control, and pharmacokinetic studies.
• Biologics Manufacturing: Used in the GMP-compliant production of finished dosage forms, such as injectable solutions.
• Mechanistic Studies: Employed in academic and industrial research to study antibody-antigen interactions and plaque clearance pathways.
• Biosimilar Development: Acts as a benchmark molecule for the development and analytical characterization of biosimilar candidates.

Basic Information

Product Name	Aducanumab
CAS No.	1384260-65-4
Molecular Formula	C6472H10028N1740O2010S46
Molecular Weight	Approx. 146 kDa
Synonyms	BIIB037; Aducanumab-avwa; Anti-Amyloid Beta Monoclonal Antibody; Aduhelm™; Anti-ABeta Antibody; Amyloid β-Targeting Monoclonal Antibody
EINECS	Contact for details

Quality Control

Our Aducanumab is manufactured and controlled under a quality management system designed for biologics. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, aligning with ICH guidelines. A Certificate of Analysis (COA) detailing specifications and results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store frozen at -20°C to -80°C. Avoid repeated freeze-thaw cycles. Under recommended storage conditions, the product remains stable for the duration indicated on the label. This material is hygroscopic (moisture-sensitive).

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (SEC-HPLC)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 95.0% Monomer
Assay (Protein Content)	90.0% - 110.0% of label claim
Potency (Cell-Based Assay)	Within specified range
Endotoxin	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Host Cell DNA	< 10 pg/mg

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