Description

Efmoroctocog Alfa CAS NO 1270012-79-7 is a recombinant coagulation factor VIII protein, engineered for extended half-life and enhanced stability. This advanced therapeutic protein is critical for providing reliable and effective prophylactic treatment for patients with hemophilia A. It is primarily utilized by biopharmaceutical manufacturers and contract development and manufacturing organizations (CDMOs) engaged in the production of next-generation hemophilia therapies.

Application

• Active Pharmaceutical Ingredient (API) for long-acting hemophilia A treatments.
• Biosimilar Development as a reference or target molecule for formulation research.
• Pre-clinical and Clinical Research for studying pharmacokinetics and efficacy of factor VIII therapies.
• Process Development in biomanufacturing for scale-up and optimization of recombinant protein production.
• Quality Control and Analytical Standard for assay validation and comparative testing.

Basic Information

Product Name	Efmoroctocog Alfa
CAS No.	1270012-79-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	rFVIII-Fc; Recombinant Factor VIII Fc Fusion Protein; BAY 94-9027; Antihemophilic Factor (Recombinant), Fc Fusion Protein; Jivi® (Brand Name); efmoroctocog alfa; extended half-life recombinant factor VIII
EINECS	Contact for details

Quality Control

Our Efmoroctocog Alfa is manufactured and tested under a quality management system designed for active pharmaceutical ingredients. Each batch undergoes rigorous analytical testing to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. A comprehensive Certificate of Analysis (COA) detailing specifications and test 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 or below. Avoid repeated freeze-thaw cycles. This product is hygroscopic (moisture-sensitive) and must be handled under controlled, low-humidity conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/CE-SDS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0%
Assay (Chromogenic/One-stage Clotting)	90.0% - 110.0% of labeled potency
Protein Content	As per COA
Single Chain Content	As per COA
Residual Moisture (KF)	≤ 3.0%
Biological Activity	As per COA
Endotoxin (LAL)	< 1.0 EU/mg
Sterility	Sterile (or meets applicable microbial limits)

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