Oligonucleotide CDMO Services for GMP API Development and Manufacturing

PeptiStar, a Japan-based CDMO, collaborates closely with clients to meet their goals throughout the entire manufacturing process, all under GMP compliance. With experience in over 450 projects worldwide, we specialize in both peptide and oligonucleotide production. Our expertise is dedicated to driving cost savings, reducing lead times and being environmentally friendly through tailored recommendations.

All-in-One TIDES Approach for Next-Generation Therapeutics | Whitepaper

Request a Quote

Applications & Uses:

Active Pharmaceutical Ingredients
Drug conjugates

Benefits:

Offers flexible manufacturing process options to suit your needs.
Ensures smooth and consistent scaling from lab scale to commercial production while adhering to GMP standards.
Expertise in proposing strategies to reduce costs and shorten lead times.
Utilizes a variety of unique technology to optimize processing times and cost for both upstream and downstream processes.

Performance Attributes:

Capable of synthesizing oligonucleotides at a wide range of production scales, from a minimum of several dozen micrograms (µg) up to a maximum of several kilograms (kg) per year.
Downstream process areas are maintained at Class 100,000 cleanliness standards.
Continuous chromatography allows you to maximize both purity and yield effectively.
Uses mixer-dryer type lyophilization to produce homogeneous oligonucleotides and shorten processing times dramatically.

Manufacturer:

PeptiStar Inc.

Sub Category:

Oligonucleotides

Oligonucleotide Development and Manufacturing Partner

Successful oligonucleotide programs require a reliable partner across development and manufacturing. NAGASE and PeptiStar provide integrated support spanning process development, analytical development, scale-up, and GMP manufacturing to help customers advance oligonucleotide therapeutics efficiently.

Our coordinated approach supports a smooth transition from early-stage development to larger-scale manufacturing across a range of oligonucleotide modalities, including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), and phosphorodiamidate morpholino oligomers (PMOs).

Integrated Development and Manufacturing Support

Process development and optimization / Analytical method development / Scale-up support

Optimize Oligonucleotide Synthesis and Process Development

Scalable Oligonucleotide Synthesis and Process Development

A development strategy is established by connecting synthesis performance with downstream purification, isolation and analytical control.

Support for Diverse Oligonucleotide Modalities

PeptiStar tailors its technical approach to each molecule’s length, chemistry, modifications, and conjugation needs, including ASOs, siRNAs, PMOs, and other modalities.

Typical Lead Times:

Sample ( ~10 g)	3 weeks ~ 2 months
Non-GMP manufacturing ( ~1,000 g)	1 ~ 3 months
GMP manufacturing	3 ~ 4 months

※Excluding raw material procurement lead time for manufacturing

A Clear, Collaborative Path from Initial Discussion

Initial Inquiry

We discuss your molecule, development stage, target quantity, quality requirements and timeline to assess initial project fit.

Confidentiality & Technical Review

An NDA can be established when needed before our teams review the molecule, process, analytical requirements and scale-up risks.

Proposal & Project Planning

We define the scope, deliverables, schedule, responsibilities, assumptions and key technical considerations.

Kickoff & Project Execution

Both teams align on milestones and communication before beginning the agreed development, manufacturing and analytical activities.

Quality Review & Delivery

Testing results and documentation are reviewed before delivery of the API and agreed project documents.

Our project approach combines technical expertise with disciplined project management and responsive communication. NAGASE and PeptiStar work closely with customers to align requirements, identify risks and maintain clear visibility throughout the project.

Regular Project Reviews

Scheduled review meetings provide transparent updates on progress, results, risks, changes and upcoming decisions throughout project execution and delivery.