Peptide 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

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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 peptides at a wide range of production scales, up to several hundred kilograms per year.
Offers both Microwave SPPS and LPPS options for peptide synthesis.
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 peptides and shorten processing times dramatically.

Manufacturer:

PeptiStar Inc.

Sub Category:

Peptides

Peptide CDMO for NCE Development

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.

Build a Scalable Peptide Process

Synthesis, cleavage, purification, salt exchange and lyophilization are developed as one connected process to improve robustness and scalability.

Establish Phase-Appropriate Analytical Control

Analytical methods are developed alongside the manufacturing process to support process understanding, quality control and stage-appropriate testing.

Advance with Confidence to GMP Manufacturing

Scale-up risks, manufacturing requirements and quality needs are evaluated early to support an efficient transition into GMP API production.

Experiences for Unique Synthesis for Cyclic Peptides

Case Study: Scalable CDMO Insights for Cyclic Peptides

Today, integrating cyclic peptides into your R&D strategy is no longer just a challenging concept—it is a fully realizable pathway. By partnering with us and exploring our diverse portfolio, you can confidently turn complex peptide designs into scalable clinical realities.

PeptiStar has experience in the development and manufacturing of various types of cyclic peptides, including disulfide-, thioether-, and amide-linked peptides, bicyclic peptides, cyclic homo- and hetero-dimers, cyclic tetramers, and peptide drug conjugates.

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.

Regular Project Reviews

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