Description

Engerix-B is a high-purity, recombinant Hepatitis B surface antigen (HBsAg) vaccine component, identified by CAS No. 351186-51-1. This product is critical for ensuring the safety, efficacy, and consistency of vaccine formulations in the global pharmaceutical supply chain. It is primarily required by biopharmaceutical manufacturers and research institutions engaged in the development and production of prophylactic vaccines against Hepatitis B virus infection.

Application

• Active Pharmaceutical Ingredient (API) for recombinant Hepatitis B vaccines.
• Formulation Component in the production of monovalent and combination pediatric and adult vaccines.
• Reference Standard for quality control and analytical method development in vaccine manufacturing.
• Research & Development tool for immunological studies and next-generation vaccine platform development.
• Biosimilar Development as a key comparator antigen for establishing bioequivalence.

Basic Information

Product Name	Engerix-B
CAS No.	351186-51-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Hepatitis B Surface Antigen (HBsAg); Recombinant HBsAg; Hepatitis B Vaccine (Recombinant); rHBsAg; HB Vaccine Antigen; Hepatitis B Virus Major Surface Antigen; GSK Engerix-B® Antigen; HBsAg adw subtype
EINECS	Contact for details

Quality Control

Our Engerix-B is manufactured and tested under strict quality systems to meet the exacting standards of the global pharmaceutical industry. Each batch is supported by a comprehensive Certificate of Analysis (COA) confirming identity, purity, potency, and safety. We adhere to relevant cGMP guidelines and support compliance with major pharmacopoeial standards (e.g., USP, EP) as required for vaccine API production.

Storage

Preserve in a tightly closed container, protected from light. Store at the recommended temperature of 2°C to 8°C (refrigerated, do not freeze). Maintain the cold chain during transport and storage to ensure product stability and potency.

Specification

Item	Specification
Appearance	White to off-white suspension
Identification (Immunoassay)	Conforms
Protein Content	≥ 95% (HPLC)
Potency (Immunogenicity)	Conforms to reference
Purity (SDS-PAGE)	≥ 98%
Endotoxin	< 5 EU/mL
Sterility	Sterile
pH	6.5 - 7.5
Aluminum Content	0.25 - 0.5 mg/mL

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