Description

Eculizumab is a recombinant humanized monoclonal antibody specifically designed to target the complement protein C5. This product is of critical importance in the biopharmaceutical sector for its targeted therapeutic action. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for rare blood disorders.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of targeted biologic therapies.
• Key component in the manufacturing of treatments for Paroxysmal Nocturnal Hemoglobinuria (PNH).
• Essential for the production of therapeutics for Atypical Hemolytic Uremic Syndrome (aHUS).
• Critical raw material in biopharmaceutical research and development (R&D) for complement-mediated diseases.
• Used in the production of reference standards and quality control materials for bioassays.
• Fundamental for process development and scale-up activities in biomanufacturing facilities.

Basic Information

Product Name	Eculizumab
CAS No.	219685-50-4
Molecular Formula	C6484H10028N1732O2016S44
Molecular Weight	~148 kDa
Synonyms	Soliris; Anti-C5 Monoclonal Antibody; h5G1.1; Humanized Anti-C5 Antibody; 5G1.1; Complement Component 5 Inhibitor; Anti-Complement Component C5 Antibody; EINECS Contact for details

Quality Control

Our Eculizumab is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, adhering to relevant ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed specifications.

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. The product is hygroscopic (moisture-sensitive) and should be handled under controlled conditions to maintain integrity.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Protein Content	As per COA
Biological Activity (Cell-based Assay)	As per COA
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Residual DNA	< 10 pg/mg

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