Description

Ruplizumab is a high-purity, biologically active monoclonal antibody designed for targeted therapeutic applications. This compound is critical for advanced pharmaceutical research and development, particularly in immunology and oncology. It is essential for researchers and manufacturers in the biopharmaceutical industry developing next-generation treatments for autoimmune and inflammatory diseases.

Application

• Primary Pharmaceutical Ingredient: Used as the active pharmaceutical ingredient (API) in the formulation of biologic drugs targeting specific immune pathways.
• Immunology Research: A vital tool for in vitro and in vivo studies investigating T-cell mediated immune responses and modulation.
• Autoimmune Disease Therapy Development: Central to R&D programs for novel treatments of conditions like psoriasis, rheumatoid arthritis, and multiple sclerosis.
• Pre-clinical & Clinical Studies: Serves as a reference standard and therapeutic agent in pharmacokinetic, pharmacodynamic, and safety evaluation studies.
• Bioconjugation & Drug Delivery Systems: Utilized in the development of antibody-drug conjugates (ADCs) and other targeted delivery platforms.
• Diagnostic Reagent Development: Employed in the creation of high-specificity assay kits and diagnostic tools for immune marker detection.

Basic Information

Product Name	Ruplizumab
CAS No.	220651-94-5
Molecular Formula	Contact for details
Molecular Weight	Approx. 145-150 kDa (Monoclonal Antibody)
Synonyms	Anti-CD2 Monoclonal Antibody; Anti-LFA-3 Monoclonal Antibody; IDEC-131; Anti-CD2 Mab; Alefacept (related therapeutic); LFA-3/IgG1 Fusion Protein (related); T-cell Modulating Antibody; Immunosuppressive Antibody
EINECS	Contact for details

Quality Control

Our Ruplizumab is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing including HPLC for purity and aggregation analysis, SDS-PAGE and capillary electrophoresis for identity and impurity profiling, and functional bioassays to confirm biological activity. We adhere to relevant ICH guidelines for biopharmaceuticals. A comprehensive Certificate of Analysis (COA) detailing purity, potency, endotoxin levels, and sterility is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized material at -20°C or below. Reconstituted solutions should be aliquoted and stored at -70°C to -80°C to prevent repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive); ensure containers are sealed under controlled, low-humidity conditions.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear solution
Identification (HPLC/CE-SDS)	Conforms to Reference Standard
Purity (SEC-HPLC)	≥ 95.0% Monomer
Protein Content (UV A280)	95.0 - 105.0% of label claim
Biological Activity (Cell-based Assay)	≥ 90% of Reference Standard
Endotoxin	< 1.0 EU/mg
Sterility (Membrane Filtration)	Sterile
Moisture Content (Karl Fischer)	< 3.0% (for lyophilized form)

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