Description

Palivizumab is a humanized monoclonal antibody (IgG1κ) specifically designed for immunoprophylaxis against respiratory syncytial virus (RSV) in high-risk pediatric populations. Its primary value lies in its targeted mechanism of action, binding to the F protein of RSV to prevent viral fusion and entry into host cells, thereby reducing the incidence of severe lower respiratory tract infections. This product is essential for pharmaceutical manufacturers, biotechnology companies, and clinical research organizations engaged in the development, formulation, and production of biotherapeutic agents for infectious diseases.

Application

• Active Pharmaceutical Ingredient (API): Primary use as the bulk drug substance in the commercial manufacture of the prophylactic medication for RSV.
• Biopharmaceutical Research: Critical reference standard and material for ongoing virology and immunology research focused on RSV pathogenesis and antibody-mediated neutralization.
• Formulation Development: Used in stability studies and the development of liquid or lyophilized dosage forms for parenteral administration.
• Biosimilar Development: Serves as a key comparator for companies developing biosimilar versions of the monoclonal antibody therapy.
• Clinical Trial Material: Supplied as a GMP-grade material for use in Phase I-IV clinical trials investigating new indications or delivery methods.
• Diagnostic Reagent Development: Can be utilized in the development of high-specificity immunoassays and diagnostic kits for RSV detection.

Basic Information

Item	Detail
Product Name	Palivizumab
CAS No.	188039-54-5
Molecular Formula	C6398H9846N1698O2011S46
Molecular Weight	Approx. 148 kDa
Synonyms	Palivizumab; Synagis; MEDI-493; Anti-RSV monoclonal antibody; Humanized monoclonal antibody IgG1κ anti-RSV; RSV mAb; 5C4; PRO 542 (related development); EINECS: Contact for details

Quality Control

Our Palivizumab is manufactured and tested under a quality management system designed for biopharmaceutical actives. Each batch undergoes comprehensive analytical characterization to ensure identity, purity, potency, and safety, aligning with ICH Q6B guidelines for biotechnological products. A Certificate of Analysis (COA) is provided with each shipment, detailing specifications for critical quality attributes such as purity by SEC-HPLC, host cell protein content, endotoxin levels, and biological activity. We support regulatory filings with data packages suitable for GMP applications.

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. Under these conditions, the product remains stable for the duration indicated on the certificate of analysis. This material is hygroscopic (moisture-sensitive); ensure containers are sealed properly after use to prevent moisture uptake.

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)
Assay (Protein Content)	90.0% - 110.0% of label claim
Potency (ELISA/Neutralization)	90% - 125% of reference
Host Cell Proteins (HCP)	< 100 ppm
Endotoxin	< 1.0 EU/mg
pH	6.0 - 7.5 (for solution)
Moisture Content (K.F.)	< 3.0% (for lyophilized powder)

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