CDMO Oligonucleotide API

High-quality oligonucleotide API manufacturing through PeptiStar collaboration.
End-to-end support from process development to GMP production and analytics.

Comprehensive CDMO for Oligonucleotide API Development and Manufacture

NAGASE provides contract development and manufacturing organization (CDMO) services for Oligonucleotide Active Pharmaceutical Ingredients (APIs) through its partnership with PeptiStar, a Japanese CDMO known for proprietary process know-how and competitive cost structures. Capabilities span process development and scale-up, non-GMP and GMP production from small to commercial scale, and full analytical support including method development, validation, and stability studies to meet regulatory expectations.

NAGASE supplies these CDMO solutions globally with technical support and international logistics for pharmaceutical programs worldwide.

Applications

Oligonucleotide APIs are used across diverse therapeutic and diagnostic workflows in modern drug development.

  • Antiviral therapeutics based on nucleoside/nucleotide analogs
  • Oncology programs requiring nucleotide-based actives or intermediates
  • Diagnostic reagents for molecular assays and kit manufacturing
  • Biopharma R&D – lead optimization and preclinical supply
  • Clinical and commercial supply of nucleotide API batches

Features

CDMO services combine proprietary process expertise, GMP readiness, and robust analytics for reliable Oligonucleotide API supply.

  • Process development & scale-up – Efficient transfer from lab to commercial scale
  • GMP/non-GMP flexibility – Small to commercial batches across phases
  • Analytical method development – Fit-for-purpose assays for nucleotides
  • Validation & stability – Regulatory-aligned qualification and shelf-life data
  • Cost-competitive production – Proprietary processes to optimize COGS

Service

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

Frequently Asked Questions about CDMO Oligonucleotide API

What does a CDMO for Oligonucleotide APIs provide?
A CDMO delivers process development, scale-up, and GMP/non-GMP manufacturing plus analytics to bring nucleotide APIs from R&D to market.

Who is PeptiStar in this collaboration?
PeptiStar is a Japanese CDMO with proprietary processes for high-quality, cost-competitive nucleotide API production.

Can NAGASE support GMP manufacturing and commercial scale?
Yes. Through PeptiStar, projects can progress from small non-GMP to full GMP and commercial-scale supply.

What analytical services are included?
Analytical method development, method validation, and stability studies to support release, comparability, and regulatory filings.

Is global supply and support available?
Yes. NAGASE provides worldwide coordination, technical support, and logistics across development phases.

Could not find what you were looking for?

Please get in touch. We strive to meet your needs.

Pharmaceuticals

Satoshi Tsubuko
Unit Manager

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