Description

Ipilimumab is a fully human monoclonal antibody that functions as an immune checkpoint inhibitor, specifically targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). This mechanism is critical for modulating T-cell activation and is a cornerstone of modern immuno-oncology therapeutics. It is essential for pharmaceutical manufacturers and research institutions developing advanced cancer immunotherapies, particularly for the treatment of metastatic melanoma and other solid tumors. The product referenced as Ipilimumab CAS NO 477202-00-9 is supplied to support both clinical development and commercial manufacturing.

Application

• Oncological Therapeutics: Primary active pharmaceutical ingredient (API) in the formulation of checkpoint inhibitor drugs for cancer treatment.
• Metastatic Melanoma Treatment: Key component in therapies for unresectable or metastatic melanoma, often in combination with other agents.
• Clinical Research & Development: Used in preclinical and clinical trials to investigate new combination therapies and expanded oncology indications.
• Biosimilar Development: Serves as a reference standard for companies developing biosimilar versions of established CTLA-4 inhibitor therapies.
• Biopharmaceutical Manufacturing: Critical raw material for large-scale GMP production of finished biologic drug products.
• Immunology Research: A vital tool for academic and industrial research into T-cell biology and immune system regulation.

Basic Information

Product Name	Ipilimumab
CAS No.	477202-00-9
Molecular Formula	C6742H9972N1732O2004S40
Molecular Weight	~148 kDa
Synonyms	MDX-010; MDX-CTLA-4; BMS-734016; Anti-CTLA-4 monoclonal antibody; Yervoy (trade name); IgG1 kappa, anti-(human CTLA-4) (human monoclonal heavy chain), disulfide with human monoclonal light chain, dimer; CTLA-4 blocking antibody; Ipilimumab-yfgr
EINECS	Contact for details

Quality Control

Our Ipilimumab is manufactured and controlled under a strict quality management system. Each batch is subjected to a comprehensive battery of analytical tests to ensure identity, purity, potency, and safety, meeting the stringent requirements for biopharmaceutical active substances. Certificates of Analysis (COA) are provided, detailing specifications for purity (by SEC-HPLC and CE-SDS), potency (cell-based bioassay), host cell protein levels, and endotoxin content. Quality standards align with ICH guidelines and current Good Manufacturing Practice (cGMP).

Storage

Preserve in a tightly closed container, protected from light. This product is hygroscopic (moisture-sensitive) and light-sensitive (store away from light). For long-term stability, store frozen at -20°C to -80°C. Avoid repeated freeze-thaw cycles. Under these conditions, the product remains stable for the duration specified on the certificate of analysis.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Mass Spectrometry)	Conforms
Purity (SEC-HPLC)	≥ 98.0% Monomer
Purity (CE-SDS, Reduced)	Heavy Chain & Light Chain bands present
Potency (Cell-based Bioassay)	90% - 120% of Reference Standard
Protein Content (A280)	95% - 105% of label claim
pH	6.0 - 7.0 (for solution)
Endotoxin	< 1.0 EU/mg
Host Cell Protein	< 100 ppm
Sterility (for aseptic fill)	Sterile

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