CDMO Peptide API

High-quality peptide API manufacturing through PeptiStar® collaboration.
Delivering innovative process development, GMP production, and comprehensive analytical support.

Advanced CDMO Solutions for Peptide API Development and Manufacture

NAGASE provides contract development and manufacturing organization (CDMO) services for Peptide Active Pharmaceutical Ingredients (APIs) through its partnership with PeptiStar Inc.®, a technology-driven CDMO established in Osaka, Japan in 2017. PeptiStar® offers value-added services by leveraging cutting-edge manufacturing technologies to produce complex peptide APIs with high quality and efficiency.

Capabilities include innovative process development, non-GMP and GMP production at scales from laboratory to commercial manufacturing, and comprehensive analytical services. These services are designed to meet the regulatory and technical requirements of modern peptide-based therapeutics.

NAGASE supplies these CDMO solutions globally, providing full technical support and international logistics for pharmaceutical partners worldwide.

Applications

Peptide APIs are utilized in a wide range of therapeutic areas and diagnostic applications.

  • Peptide-based drugs for oncology, metabolic disorders, and infectious diseases
  • Hormonal peptides for endocrine therapies
  • Diagnostic reagents for immunoassays and biomarker detection
  • Research-grade peptides for preclinical and clinical development
  • Specialty formulations requiring high-purity peptide APIs

Features

PeptiStar® combines innovative manufacturing technologies with regulatory compliance to deliver high-quality peptide APIs.

  • Advanced synthesis technologies – Innovative approaches for complex peptide structures
  • Scalable manufacturing – From small-scale development to commercial GMP production
  • Regulatory expertise – Compliance with global GMP standards
  • Comprehensive analytics – Method development, validation, and stability testing
  • Global supply chain – Reliable delivery supported by NAGASE logistics

Service

・Process Development, Scale up
・non-GMP / GMP Production (small – commercial scale)
・Analytical Method Development, Validation, Stability Study
・Regulatory Support

Frequently Asked Questions about CDMO Peptide API

What does a CDMO for Peptide APIs provide?
A CDMO delivers process development, scale-up, GMP/non-GMP manufacturing, and analytics for peptide-based active pharmaceutical ingredients.

Who is PeptiStar® and what is their expertise?
PeptiStar® is a Japanese CDMO specializing in innovative technologies for the manufacturing of complex peptide APIs.

Does NAGASE offer GMP peptide API production?
Yes. Through PeptiStar®, NAGASE provides GMP manufacturing from small to commercial scale.

What analytical services are included?
Analytical method development, method validation, and stability testing to ensure product quality and compliance.

Can NAGASE supply peptide APIs worldwide?
Yes, NAGASE provides global supply, technical support, and logistics for peptide API programs.

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Pharmaceuticals

Satoshi Tsubuko
Unit Manager