What Is a Peptide CDMO?
A Contract Development and Manufacturing Organisation (CDMO) provides outsourced pharmaceutical manufacturing services to companies that do not operate their own production facilities. A peptide CDMO specialises in the synthesis, formulation, filling, testing, and packaging of peptide-based products on behalf of clients.
For distributors, brand owners, and research organisations, partnering with a peptide CDMO eliminates the capital cost of in-house manufacturing while providing access to specialist synthesis expertise, analytical infrastructure, and scalable production capacity. ShiLai™ Healthcare operates as a full-service peptide CDMO with particular depth in injectable delivery systems — pre-filled pens, dual-cartridge pens, and lyophilized vials.
CDMO Service Scope
Custom Peptide Synthesis
Solid-phase peptide synthesis (SPPS) for research-grade and commercial-scale peptides. Fmoc and Boc chemistry available. Sequences from 2 to 50+ amino acids, including modified, cyclic, and conjugated peptides.
Lyophilization & Vial Filling
Freeze-drying services for peptide bulk drug substance and finished vials. Lyophilized vials offer extended shelf life and cold-chain flexibility. Available in 2mg, 5mg, 10mg, and custom fill weights.
Pre-Filled Pen & Cartridge Filling
Aseptic filling of pre-filled injection pens and dual-cartridge pen systems. Suitable for peptides requiring precise dosing and patient-friendly delivery formats. OEM and private-label configurations available.
Analytical Development & QC
In-house RP-HPLC purity analysis and LC-MS identity confirmation for every batch. Method development, specification setting, and full COA documentation. Independent batch release before shipment.
Packaging & Private Label
Custom packaging design, private-label printing, and branded kit assembly. Suitable for distributors and brand owners requiring finished, market-ready product. MOQ and lead time discussed per project.
Project Management & Regulatory Support
Dedicated project manager assigned to each CDMO engagement. Batch records, COA documentation, and quality agreements available for partners with regulatory filing requirements.
The ShiLai™ CDMO Process
Initial Enquiry
Submit your peptide sequence, target specifications, delivery format, and estimated volume via WhatsApp or email. We respond within 24 hours.
Feasibility & Quotation
Our technical team reviews the project scope, confirms feasibility, and provides a detailed quotation covering synthesis, testing, filling, and packaging.
Project Agreement
A project agreement and quality agreement are signed. Raw material sourcing and synthesis scheduling begin upon receipt of deposit.
Synthesis & Manufacturing
Peptide synthesis, purification, lyophilization or liquid filling, and packaging are carried out according to agreed specifications and timelines.
Analytical Testing & Release
Every batch undergoes RP-HPLC purity analysis and LC-MS identity confirmation. A Certificate of Analysis is issued before shipment.
Shipment & Documentation
Finished product ships with full batch documentation. Cold-chain logistics arranged where required. Tracking provided upon dispatch.
Peptide Manufacturing Capabilities
ShiLai™ Healthcare has established synthesis and analytical processes for the following peptides. Custom sequences outside this list are evaluated on a project-by-project basis.
Finished Product Delivery Formats
| Format | Description | Typical Application |
|---|---|---|
| Pre-Filled Injection Pen | Single-use or multi-dose pen pre-filled with peptide solution | Retatrutide, NAD+, GHK-Cu, BPC-157+TB-500, and 25+ other peptides |
| Dual-Cartridge Pen System | Two-chamber cartridge: lyophilized peptide + diluent mixed at point of use | Peptides requiring separation of active and diluent for stability |
| Lyophilized Vial | Freeze-dried powder in sealed glass vial, reconstituted before use | Maximum stability; suitable for research and clinical-grade supply |
| Nasal Spray | Peptide solution in nasal spray device for needle-free delivery | DSIP, Selank, Semax, NAD+, BPC-157+TB-500 |
| Bulk API | Purified peptide bulk drug substance, lyophilized or in solution | Partners with in-house formulation or filling capability |
Quality Assurance & Batch Traceability
Every batch manufactured by ShiLai™ Healthcare is assigned a unique batch number at synthesis and tracked through to the Certificate of Analysis (COA) and shipping documentation. Analytical testing — RP-HPLC purity and LC-MS identity — is performed in-house on every batch before release.
CDMO partners requiring batch manufacturing records (BMRs), quality agreements, or additional documentation for regulatory submissions can request these as part of the project agreement.
CDMO vs OEM: Which Service Do You Need?
| Requirement | CDMO | OEM / Private Label |
|---|---|---|
| Custom peptide sequence or novel formulation | ✓ Full development scope | — Standard catalogue peptides only |
| Private-label packaging under your brand | ✓ Available | ✓ Core service |
| Analytical method development | ✓ Included | — Standard COA only |
| Batch manufacturing records (BMR) | ✓ Available on request | — Not standard |
| Regulatory documentation support | ✓ Available | — Limited |
| Minimum order quantity | Project-dependent | Lower MOQ available |
Not sure which service fits your project? Ask us on WhatsApp and we'll advise based on your requirements.
Frequently Asked Questions
What is the minimum order quantity for CDMO projects?
MOQ depends on the peptide, delivery format, and project scope. Contact ShiLai™ Healthcare via WhatsApp with your project details and we will confirm feasibility and minimum quantities.
Can ShiLai™ Healthcare synthesise a custom peptide sequence not in your catalogue?
Yes. Custom sequences are evaluated on a project-by-project basis. Submit your sequence, target purity, quantity, and delivery format and our technical team will assess feasibility and provide a quotation.
What analytical testing is included in the CDMO service?
Every batch includes RP-HPLC purity analysis and LC-MS identity confirmation as standard. Additional testing (endotoxin, residual solvents, water content, etc.) can be arranged on request.
Do you provide batch manufacturing records (BMRs) for regulatory submissions?
BMRs are available to qualified CDMO partners under a signed quality agreement. Discuss your documentation requirements at the project agreement stage.
What is the typical lead time for a CDMO project?
Lead time depends on peptide complexity, delivery format, and order volume. Standard catalogue peptides in pre-filled pen format typically ship within 3–6 weeks from project agreement. Custom sequences require additional development time.
Can you handle cold-chain shipping for finished product?
Yes. ShiLai™ Healthcare arranges cold-chain logistics for temperature-sensitive peptide products. Shipping conditions are confirmed at the project agreement stage.
Start Your Peptide CDMO Project
Contact ShiLai™ Healthcare via WhatsApp with your peptide sequence, target format, and estimated volume. Our team responds within 24 hours.
Discuss Your CDMO Project