Description

Emicizumab is a humanized bispecific monoclonal antibody engineered to bridge activated factor IX and factor X, effectively mimicking the cofactor function of factor VIII. This innovative mechanism of action makes it a critical therapeutic agent for the management of hemophilia A, particularly in patients with inhibitors. It is primarily utilized by pharmaceutical manufacturers and research institutions focused on hematology and advanced biologics. Emicizumab CAS NO 1610943-06-0 represents a significant advancement in prophylactic treatment, offering a subcutaneous administration route with a long half-life.

Application

• Pharmaceutical Active Ingredient (API): Primary use as the active component in finished drug products for the treatment of hemophilia A.
• Prophylaxis Treatment: Formulation into injectable solutions for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
• Research & Development: Serves as a key reference standard and material in preclinical and clinical studies for novel hemophilia therapies.
• Biologics Manufacturing: Used by contract development and manufacturing organizations (CDMOs) for the production of biosimilar or next-generation biologic candidates.
• Clinical Trial Material: Supplied as GMP-grade material for Phase I-III clinical trials investigating new indications or delivery methods.

Basic Information

Product Name	Emicizumab
CAS No.	1610943-06-0
Molecular Formula	Contact for details
Molecular Weight	~148 kDa
Synonyms	ACE910; Hemlibra; RO5534262; Anti-Factor IXa/Factor X Bispecific Antibody; Emicizumab-kxwh; RG6013; Bispecific Monoclonal Antibody ACE910
EINECS	Contact for details

Quality Control

Our Emicizumab is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting the stringent requirements for biopharmaceutical actives. Certificates of Analysis (COA) are provided, detailing results for critical quality attributes including assay, purity by SE-HPLC and CE-SDS, host cell protein, endotoxin, and bioburden. Production is aligned with cGMP guidelines to ensure consistency and reliability for global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration indicated on the certificate of analysis.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SE-HPLC)	≥ 98.0% (Monomer)
Purity (CE-SDS, reduced)	≥ 95.0% (Heavy & Light Chain)
Assay (Protein Content)	90.0% - 110.0% of label claim
Potency (Biological Activity)	90% - 125% of reference
Endotoxin	< 1.0 EU/mg
Bioburden	Meets Ph. Eur. 2.6.27 / USP <71>
pH	5.5 - 6.5 (for solution)

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