Peptide CDMO Services

Peptide CDMO Services

Peptide drug substance development and manufacturing — from discovery support through clinical and commercial supply.

A CDMO Partner for Peptide Drug Development

SynPeptide is a peptide CDMO: we develop and manufacture peptide drug substance for programs moving from discovery toward the clinic and the market. A CDMO does more than make a peptide. Across peptide drug development, we support the chemistry at every stage, synthesizing candidates and analogs, applying modifications that improve druggability, developing and validating the analytical methods, characterizing impurities, and scaling the chosen molecule up to GMP-ready production. From early research batches to clinical and commercial supply, one team carries the chemistry and the documentation forward. Since 2013 we have supported peptide programs for developers in more than 100 countries.

Discovery to Commercial

One partner from candidate and analog synthesis through clinical trials and into commercial production.


Development + Manufacturing

We handle route and analytical method development, druggability work, and the manufacturing that follows.


GMP-Ready Supply

Material supplied to the quality level your program needs, up to GMP-ready production.


Backed by 50+ Patents

Built on more than 50 granted patents and over 15,600 academic citations since 2013.


Specifications

StageWhat HappensHow We Support
Discovery & DesignTarget selection, sequence design, hit findingSynthesis of candidates and analogs; peptide libraries
Lead OptimizationImprove potency, stability, and druggabilityCyclization, stapling, PEGylation, capping; SAR libraries
PreclinicalCharacterization, early PK, safetyAnalog and labeled-peptide synthesis; reference standards
Process DevelopmentLock a defined, repeatable synthesis routeRoute and analytical method development; impurity control
Clinical SupplyGMP drug substance and CMC documentationGMP-ready API manufacturing; CMC documentation support
CommercialReliable supply at scaleScale-up to multi-kilogram production
* SynPeptide provides the chemistry and manufacturing support shown above. Biological screening and in vivo studies are handled by your team or specialist partners.


What We Cover, Discovery to Commercial

We support the chemistry across the whole program: designing and making analogs, improving druggability, developing the process, and manufacturing the chosen molecule under GMP-ready conditions.

Candidate & Analog Synthesis

Fast synthesis of the lead and its analogs, so a medicinal-chemistry idea can be tested in weeks and the program keeps moving.


Lead Optimization & Druggability

Cyclization, stapling, PEGylation, and terminal capping to improve stability, half-life, and binding, with each change tested against potency.


Process Development

We design and optimize the synthesis route, choosing SPPS, LPPS, or a hybrid approach to fit the sequence, cost, and scale.


Analytical Method Development

Methods for identity, purity, potency, and impurities are developed and validated so each batch is released against a clear specification.


Impurity Characterization & Control

Process- and product-related impurities are identified, characterized, and controlled to meet the tight profiles a drug program requires.


GMP-Ready API Manufacturing

Peptide API is produced to the quality level your stage needs, up to GMP-ready manufacturing for clinical and commercial supply.


CMC & Regulatory Support

We prepare the chemistry, manufacturing, and controls documentation that supports IND and clinical filings.


Scale-Up & Tech Transfer

The same process scales from gram batches to multi-kilogram campaigns, with technology transfer that keeps quality consistent.




Development and Manufacturing Under One Roof

A peptide drug program stalls when development and manufacturing sit in different places. We keep them together. The team that designs the route and the analytical methods is the team that scales and makes the material, so nothing is lost in a handoff. That continuity is the point of a CDMO, and it is harder to get from a custom synthesis shop or a contract manufacturer alone.

· Route and method development in-house
· The same team scales and manufactures
· No tech-transfer gap between development and supply
· One point of contact across stages



Built for the Drug Development Lifecycle

A peptide program needs different things at different stages. Early on, the work is candidate and analog synthesis, library support, and process and analytical development. Moving into the clinic, GMP-ready supply and CMC documentation take over. We plan the chemistry so an early decision does not box in a later stage, and we scale through large-scale production as the program grows.

· Discovery-stage analog and library synthesis
· Clinical-stage GMP-ready supply
· Commercial scale-up planning
· Decisions made with later stages in mind



Druggability and Analytical Rigor

Most peptide leads fail first on stability, half-life, or permeability, and chemistry is how you fix that. Peptide modification does the heavy lifting, and for a drug substance the impurity profile matters as much as the peptide itself. We develop and validate identity, purity, and potency methods, then control process- and product-related impurities against a defined specification.

· Cyclization, stapling, and PEGylation for druggability
· Validated identity, purity, and potency methods
· Impurity identification and control
· Release against a fixed specification



GMP-Ready Supply and Regulatory Support

When a program reaches the clinic, the supply has to come with the right paperwork. We offer GMP-ready manufacturing and prepare the chemistry, manufacturing, and controls documentation an IND or clinical filing needs, including batch records, method reports, and stability data. Tell us the stage and the market, and we will scope the quality level and the documents to match.

· GMP-ready production on request
· CMC documentation for filings
· Batch records and method reports
· Stability data for submissions

About SynPeptide

Founded in 2013 in Nanjing, China. 150+ team members, 50+ patents, 15,600+ citations. Serving 100,000+ researchers in 100+ countries.

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FAQs

What is a peptide CDMO?

A peptide CDMO, a contract development and manufacturing organization, both develops and manufactures peptide drug substance. It goes beyond a contract manufacturer by also handling the synthesis route, the analytical methods, and the documentation a drug program needs, in addition to the production.

What does your peptide CDMO service include?

Candidate and analog synthesis, lead optimization, process and analytical method development, impurity characterization, scale-up, GMP-ready API manufacturing, stability studies, and CMC documentation support. You can use the full package or only the parts your program needs.

Can you support a program from discovery through commercial?

Yes. We support peptide programs across the lifecycle: candidate and analog synthesis and process development early on, GMP-ready supply and CMC documentation for clinical stages, and scale-up for commercial volume.

Do you support peptide drug discovery and lead optimization?

We support the chemistry side of discovery and optimization: we synthesize candidates and analogs, build libraries for structure-activity studies, and make constrained and labeled peptides. We do not run biological screening ourselves, but we make the molecules those screens need.

Do you provide GMP-grade peptide API?

We offer GMP-ready peptide API for preclinical and clinical programs, with batch records, validated methods, and stability data. Tell us your program stage and the quality level you require, and we will confirm what we can support.

What CMC and regulatory documentation do you provide?

We prepare chemistry, manufacturing, and controls documentation to support IND and clinical filings, including the synthesis description, analytical methods and validation, impurity data, and stability results. We work with your regulatory team on the format they need.

How do you improve a peptide's druggability and stability?

Chemistry. Cyclization and terminal capping slow enzymatic degradation, stapling locks an active conformation, and PEGylation extends circulation time. We test each modification against potency so a stability fix does not weaken the molecule.

What do you need to start a project?

Send the sequence, the purity and impurity targets, the scale you expect, and your program stage. If the peptide has modifications or a specific salt form, include those. We will scope the development steps, the manufacturing, and the documentation.

Understanding Peptide Drug Development

Peptide drug development is the work of turning a bioactive sequence into an approved therapeutic, from discovery and design, through lead optimization and preclinical testing, to GMP manufacturing for the clinic and the market. Peptides have become one of the fastest-growing classes of new drugs, and most of the difficulty along the way is chemistry. A peptide CDMO exists to carry that chemistry, providing both the development work and the production a program needs.

Why Peptide Therapeutics Are Growing

Peptides occupy a useful middle ground. They are more specific and less toxic than most small molecules, and smaller and easier to synthesize than antibodies. They can also block protein-protein interactions, a target class that has frustrated small-molecule discovery for decades. Advances in synthesis, modification, and delivery have widened what is possible, and approvals across metabolic disease, oncology, and rare disease have followed.

The Druggability Challenges

A natural peptide is usually a poor drug as it stands. Three problems dominate. Stability: peptide bonds are cut quickly by proteases in blood and tissue. Half-life: small peptides are cleared by the kidneys within minutes. Permeability: most peptides cross cell membranes poorly, which limits oral dosing and intracellular targets. Much of peptide drug development is fixing these without losing the activity that made the sequence interesting in the first place.

Constrained Peptides in Drug Discovery

One of the most productive answers is to constrain the peptide. Cyclization, stapling, and bicyclic designs lock the backbone into a defined shape. A constrained peptide binds its target more tightly because it pays a smaller entropic penalty on binding, resists proteases because the cleavage sites are less accessible, and can show better permeability than its linear form. Constrained and stapled peptides now appear throughout modern peptide drug discovery for exactly these reasons.

Working With a Peptide CDMO

A contract manufacturing organization (CMO) makes a peptide to a process you hand over. A CDMO also develops that process: it works out the synthesis route, builds and validates the analytical methods, characterizes impurities, and prepares the documentation. For a peptide drug, where small changes in sequence or impurity profile matter, keeping development and manufacturing in one place usually pays off. We support the chemistry across the whole path; for the underlying services, see custom peptide synthesis, peptide modification, and large-scale peptide synthesis.

All peptides are supplied for research and pharmaceutical development use, in line with each program's regulatory requirements.

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Online Consultation Email: dora@synpeptide.com Tel: +86 135 0517 2290 WhatsApp: +86 135 0517 2290