Description

Trastuzumab CAS NO 180288-69-1 is a recombinant humanized monoclonal antibody specifically designed to target the human epidermal growth factor receptor 2 (HER2). This targeted biologic is a cornerstone in precision medicine, offering a critical therapeutic pathway for aggressive cancer types. It is primarily utilized in the biopharmaceutical and clinical research sectors for the development and manufacturing of targeted oncology treatments.

Application

• Oncological Therapeutics: Primary active pharmaceutical ingredient (API) for the treatment of HER2-positive metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.
• Biosimilar Development: Reference standard and key material for the research, development, and analytical characterization of trastuzumab biosimilars.
• Drug Conjugate Payload: Used as the targeting antibody component in antibody-drug conjugates (ADCs) for enhanced tumor-specific drug delivery.
• Clinical Research: Essential reagent in preclinical and clinical studies investigating HER2 biology, resistance mechanisms, and novel combination therapies.
• Biopharmaceutical Manufacturing: Serves as the master or working cell bank-derived product in large-scale GMP production processes.
• Diagnostic & Companion Diagnostic Development: Used to validate and calibrate diagnostic assays that determine HER2 status in patient tumor samples.

Basic Information

Product Name	Trastuzumab
CAS No.	180288-69-1
Molecular Formula	C6470H10012N1726O2013S42
Molecular Weight	Approx. 145,531.5 Da
Synonyms	Anti-HER2 monoclonal antibody; rhuMAb HER2; Trastuzumab (USP); Herceptin (Trade Name); Immunoglobulin G1, anti-(human epidermal growth factor receptor 2) (human-mouse monoclonal rhuMAb4D5 gamma1-chain), disulfide with human-mouse monoclonal rhuMAb4D5 κ-chain, dimer; CAS 180288-69-1; Trastuzumab-dtt (drug substance).
EINECS	Contact for details

Quality Control

Our Trastuzumab is manufactured and controlled under strict quality systems. Each batch is subjected to a comprehensive battery of analytical tests including potency (cell-based assay), purity (SEC-HPLC, CE-SDS), identity (peptide mapping, IEF), and impurity profiles (host cell proteins, DNA, aggregates). Certificates of Analysis (COA) are provided, detailing compliance with relevant specifications for drug substance.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store lyophilized powder at -20°C or below. Reconstituted or liquid formulations should be stored at 2-8°C and used promptly. Avoid repeated freeze-thaw cycles.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (Peptide Map)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% Monomer
Potency (Cell-based Assay)	90.0% - 115.0% of reference
Protein Content (A280)	90.0% - 110.0% of label claim
pH	5.5 - 6.5 (for solution)
Endotoxin (LAL)	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm

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