Description

Coagulation Factor VIIa, Human is a highly purified, recombinant or plasma-derived serine protease that is essential for initiating the extrinsic pathway of blood coagulation. This critical therapeutic protein is used to control and prevent bleeding episodes in patients with specific coagulation disorders. It is primarily required by pharmaceutical manufacturers and biotech companies engaged in the production of life-saving hemostatic agents and advanced biologic therapies for the treatment of hemophilia A or B with inhibitors, and other rare bleeding diatheses.

Application

• Hemophilia Treatment: Primary therapeutic agent for the management of bleeding episodes in patients with hemophilia A or B who have developed inhibitors to Factor VIII or Factor IX.
• Surgical Hemostasis: Used to achieve hemostasis in patients with congenital Factor VII deficiency or acquired hemophilia undergoing surgical procedures.
• Biopharmaceutical Active Pharmaceutical Ingredient (API): Serves as the key biologic active substance in the formulation of finished injectable drug products (e.g., recombinant Factor VIIa).
• Research & Development: Essential reference standard and reagent in coagulation research, hematology studies, and the development of novel hemostatic drugs and diagnostic assays.
• Diagnostic Reagent Manufacturing: Used in the production of calibrators and controls for in-vitro diagnostic (IVD) kits that test coagulation pathways.

Basic Information

Product Name	Coagulation Factor VIIa, Human
CAS No.	102786-61-8
Molecular Formula	CₙHₘNₓOₚSₜ (Protein)
Molecular Weight	~50 kDa (Glycosylated monomer)
Synonyms	Activated Factor VII; Factor VIIa; rFVIIa; Eptacog Alfa (Activated); Coagulation Factor VIIa (Activated); FVIIa; Human Coagulation Factor VIIa; NovoSeven® (Brand Name); AryoSeven™ (Brand Name); Antihemophilic Factor VIIa
EINECS	Contact for details

Quality Control

Our Coagulation Factor VIIa, Human is manufactured and tested under strict quality systems. Each batch is rigorously analyzed to ensure it meets stringent specifications for identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. Certificates of Analysis (COA) detailing specific tests such as biological activity (clotting assay), purity (SDS-PAGE, HPLC), and absence of host cell proteins are provided. We support compliance with cGMP, FDA, and EMA regulatory frameworks for pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below for long-term stability. For short-term or in-use periods, storage at 2-8°C may be acceptable based on the specific formulation and stability data. This product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature before opening to prevent condensation and moisture ingress.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (HPLC/Activity)	Conforms to reference standard
Biological Activity (Clotting Assay)	> 90% of labeled potency
Purity (SDS-PAGE, reduced)	> 95%
Purity (Size-Exclusion HPLC)	> 98% monomer
pH (Reconstituted Solution)	5.5 - 7.0
Moisture (Karl Fischer)	< 3.0%
Endotoxin (LAL)	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile

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