Description

Nelipepimut-S is a synthetic peptide antigen designed for targeted immunotherapy. This compound is a key component in the development of novel cancer vaccines, specifically targeting the HER2/neu protein. It is primarily utilized by pharmaceutical R&D departments, biotechnology firms, and clinical research organizations engaged in advanced oncology therapeutics. The material is supplied to support pre-clinical studies and clinical trial manufacturing under stringent quality protocols.

Application

• Active Pharmaceutical Ingredient (API) in cancer vaccine formulations targeting HER2/neu-positive cancers.
• Immunotherapeutic Agent for research and development of novel immunotherapies against breast cancer and other malignancies.
• Clinical Trial Material for Phase I-III studies investigating peptide-based vaccine efficacy and safety.
• Reference Standard for analytical method development and validation in quality control laboratories.
• Bioconjugation Intermediate for creating peptide-carrier protein complexes to enhance immunogenicity.
• Cell-based Assay Component used in immunological assays to measure T-cell response and immune activation.

Basic Information

Product Name	Nelipepimut-S
CAS No.	160212-35-1
Molecular Formula	C129H204N38O43
Molecular Weight	2883.2 g/mol
Synonyms	E75; HER2/neu (369-377) peptide; p369-377; GP2; AE37 (related analogue); Influenza Matrix Protein (IMP) 58-66; KIFGSLAFL; HER-2/neu-derived peptide; Cancer vaccine peptide E75
EINECS	Contact for details

Quality Control

Every batch of Nelipepimut-S is manufactured and tested under current Good Manufacturing Practice (cGMP) guidelines for peptide APIs. Our quality system ensures identity, purity, potency, and consistency for research and clinical use. Comprehensive release testing includes chiral purity, sequence verification, and stringent controls for related substances and residual solvents. Certificates of Analysis (COA) documenting full compliance with release specifications are provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store frozen at -20°C or below. The product is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a dry environment before opening to prevent condensation and hydrolysis. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Single Impurity (HPLC)	≤ 1.0%
Amino Acid Analysis	95.0% - 105.0% of theoretical
Water Content (KF)	≤ 5.0%
Acetate Content (HPLC)	≤ 10.0%
Bacterial Endotoxins	< 10 EU/mg

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