Commercial-Scale Peptide CDMO
GMP Peptide Manufacturing | NCE Development Services | IND-enabling CMC Packages | Formulation
Peptide NCE Services
GMP Peptide Manufacturing & Development
Sinopep is a leading CDMO specializing in the development and GMP manufacturing of peptide NCEs. Our comprehensive platform offers end-to-end support for peptide projects of all scales—from preclinical research through commercial production. Leveraging advanced expertise in both solid-phase and liquid-phase peptide synthesis, we excel in the synthesis of complex and challenging peptides. With flexible manufacturing capacities, modular systems, and a track record of successfully advancing multiple peptide NCEs through Phase 1–3 clinical trials and commercial supply, Sinopep provides reliable, high-quality solutions to accelerate the development and commercialization of peptide-based therapeutics.
GMP Peptide Manufacturing Video
Large-scale automated peptide synthesis
Sinopep is a trusted CDMO specializing in end-to-end CMC development and cGMP manufacturing of peptide and oligonucleotide APIs for NCEs, from early-phase development to commercialization. Since 2009, Sinopep has passed four U.S. FDA inspections and adheres strictly to FDA/ICH guidelines. Our expertise covers process and analytical method development/validation, stability studies, and regulatory support for global filings (IND/NDA).
Complete Lifecycle Support
Our comprehensive peptide platform delivers end-to-end CMC support, mitigating development risks and ensuring seamless transition from lead optimization through commercialization. The table below outlines our phase-specific activities across sequence design, process chemistry, analytical development, and clinical manufacturing:
| FUNCTION | KEY ACTIVITIES |
|---|---|
| Preclinical Phase | IND-Enabling Peptide Development |
| Synthetic Route & Strategy Selection | Evaluation of SPPS (Fmoc/tBu), LPPS, or hybrid condensation; resin selection and coupling agent screening. |
| Cleavage & Disulfide Folding | TFA cleavage cocktail optimization, scavenger screening, and air/guided oxidative folding condition development. |
| Early Purification & Counterion Screening | Preparative RP-HPLC method screening and initial counterion selection (acetate vs. chloride). |
| IND-Enabling CMC Support | Racemization profiling, deletion peptide mapping, forced degradation, and IND CMC package prep. |
| Clinical Phase I | Early Clinical Manufacturing |
| GMP Upstream & Cleavage | Tech transfer, scale-up of SPPS cycles, raw material amino acid qualification, and crude peptide isolation. |
| GMP Purification & Salt Exchange | Multi-step RP-HPLC purification, TFA-to-acetate counterion exchange, and batch lyophilization execution. |
| Analytical Release & Control | LC-MS identity confirmation, chiral HPLC amino acid analysis, residual TFA testing, and GMP release. |
| Clinical Phase II | Process Characterization & Optimization |
| Process Robustness & QbD | DoE studies on coupling temperature, racemization risk points, resin substitution rates, and cleavage parameters. |
| Purification & Isolation Scale-Up | Optimization of column loading capacity, solvent recycling strategy, and isolation/lyophilization parameters. |
| Reference Standards & Characterization | Primary peptide reference standard qualification, secondary structure assessment (CD/NMR), and stability studies. |
| Clinical Phase III | Registration Readiness |
| Commercial Process Lock | Finalization of SPPS batch parameters, resin/reagent specs, folding limits, and Master Batch Records. |
| Analytical Method Validation | ICH Q2 validation for RP-HPLC purity, chiral purity, TFA/acetate assay, MS identity, and bioburden/endotoxin. |
| Regulatory & Raw Material Security | Critical amino acid building block supplier qualification, CTD Module 3 authoring, and NDA/MAA filing. |
| Commercialization | Process Validation & Launch |
| Process Performance Qualification | PPQ campaign execution (≥3 consecutive batches), aggregation tracking, and process consistency validation. |
| Commercial Supply & Testing | Routine commercial release, lyophilization capacity validation, cold-chain distribution, and launch readiness. |
| Lifecycle Management | Continued process verification (CPV), yield improvement, green chemistry solvent optimization, and post-approval updates. |
Download NCE Development Brochure
Sinopep is a leading CDMO specializing in the development and GMP manufacturing of peptide, oligonucleotide, and small molecule NCEs. With the rapidly expanding landscape of peptide therapeutics, we have grown our peptide CDMO platform into one of our most advanced and comprehensive capabilities, leveraging cutting-edge solid-phase and liquid-phase synthesis to tackle even the most complex and challenging sequences.
Advanced Automation Technology at Scale
Flexible Scale-Up: From milligrams to hundreds of kilograms, our modular manufacturing systems support your program at every stage—from discovery to commercialization.
| Specification | Category | Value |
|---|---|---|
| Projected annual peptide | Peptide | 20–30 tons / year |
| SPPS reactors (3,000 L) | Peptide | 14+ units |
| Total reactor volume | Peptide | 65,000 L |
| Reactor size range | Peptide | 50–3,000 L |
| DAC purification column | Peptide | Up to 1,200 mm |
| Spray dryer throughput | Peptide | 32 kg / h (200+ kg / batch) |
| Oligonucleotide | Oligonucleotide | 1,000 kg / year |
| PMO (phosphorodiamidate) | Oligonucleotide | 30 kg / year |
| GMP production facilities | Infrastructure | 3 large-scale sites |
Peptide NCE Development Pipeline
As a specialized CDMO partner, Sinopep supports the end-to-end development of peptide New Chemical Entities (NCEs) across all stages—from preclinical research to commercial manufacturing. Our growing pipeline of over 10 peptide NCEs, including SNP–FB618, SNP–IBI362, and SNP–SCI241, showcases our deep expertise in complex peptide synthesis, scale-up, and formulation. With active programs spanning Phase 1 to Phase 3, NDA, and commercial supply, Sinopep offers flexible, high-quality CDMO solutions tailored to accelerate the development and launch of peptide-based therapeutics.
| Preclinical | Phase 1 | Phase 2 | Phase 3 | NDA | Commercial |
|---|
- SNP - FB618
- SNP - IBI362
- SNP - SCI241
- SNP - PEG601
- SNP - HRS953
- SNP - HDM100
- SNP - MWN109
- SNP - ELA235
- SNP - NPE013
- SNP - HEP712
- Multiple Others
Inspection History
Since 2014, Sinopep’s GMP manufacturing facilities have successfully passed four (4) inspections conducted by the U.S. FDA, demonstrating our strong commitment to global regulatory compliance and product quality. In addition to these FDA audits, Sinopep has also undergone inspections by the Korean MFDS and has successfully completed 20 regulatory audits conducted by the NMPA in China.
| Date | Inspected Product | Inspection Type | Result |
|---|---|---|---|
| Apr 2014 | Peptide API | FDA CGMP | Pass |
| Apr 2016 | Peptide API | FDA CGMP | Pass |
| Jan 2019 | Routine Inspection | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Routine Inspection (Unannounced Inspection) | FDA CGMP | Pass |
| July 2025 | Semaglutide & Liraglutide | ANVISA CGMP | Pass |
