About us
Large-Scale Production of Peptide, Oligonucleotide, and Small Molecule NCEs
About Us
Driving Innovation in Pharmaceuticals
At Sinopep, we are committed to advancing the frontiers of peptides, oligonucleotides, and small molecules as transformative therapeutic solutions. As a leader in pharmaceutical research, development, and manufacturing, we aim to set new standards across the industry. Our relentless focus on innovation, operational excellence, and scalable manufacturing has positioned us at the forefront of the global pharmaceutical landscape—delivering life-saving solutions and driving progress for our partners worldwide.
Peptide CDMO Services
Sinopep is a trusted Peptide CDMO specializing in end-to-end CMC development and cGMP manufacturing of peptide 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.
Oligo CDMO Services
Our new GMP oligonucleotide facility represents a major expansion in our ability to manufacture oligonucleotide API and NCE therapeutics, including antisense oligonucleotides (ASOs) and siRNA, at thousands of kilograms annually. Purpose-built to meet the growing global demand for advanced RNA-based medicines, this facility sets a new benchmark for large-scale oligo production.
Formulation Services
Since its founding in 2004, Sinopep has developed a robust and scalable formulation platform focused on delivering high-quality pharmaceutical products and CDMO solutions. Our recently expanded formulation facility provides even greater production capacity and an expanded range of services for our clients.
Years Experience
Employees
Capacity (MT/yr)
GMP Faclities
Why Choose Sinopep?
Why Pharma Companies Partner with Us
We combine advanced chemical modification platforms, green synthesis frameworks, and state-of-the-art automation to accelerate your high-value drug pipelines with superior yields, strict compliance, and predictable batch reproducibility.
1. Process Development & Green Synthesis Platforms
- Automated SPPS & LPPS platforms: 20 L–3,000 L automated reactors and up to 1,200 mm DAC columns delivering multi-kilogram single-batch outputs.
- Hybrid synthesis for long chains: (>50 AAs) & GLP-1 hybrids.
- Yield improvements: 30–50% with >98% purity.
- High-Concentration Disulfide Folding: High-efficiency, scalable oxidation processes engineered to reduce waste.
- Recombinant-Chemical Hybrid Platform: Solves synthesis limits for 60+ residue multi-agonist peptides by combining core fermentation with flow photochemistry.
- EcoQuench Green Technology: In situ acid neutralization of residual piperidine; cuts post-deprotection solvent by 45–65% and wash times by ~66% without purity loss.
- Continuous-Flow Photochemical Amidation: Converts C-terminal Cys handles to native primary amides in flow with 78% yield.
- Green Solvent Recycling & Recovery: Integrated closed-loop systems enabling >80% organic solvent recovery (DMF/ACN) to lower process mass intensity.
3. Large-Scale SPPS Advanced Automation
- High-Capacity Solid-Phase Reactors: Industrial-scale automated reactors (20 L to 3,000 L) optimized for high coupling efficiency and strict temperature control.
- Continuous In-Line Process Monitoring: Real-time PAT and UV/HPLC tracking to monitor deprotection and coupling completion, minimizing sequence deletions.
- Large-Diameter DAC Purification: Up to 1,200 mm dynamic axial compression column chromatography designed for commercial multi-kilogram batch isolation.
- Integrated Process Automation: Closed-loop automated reagent delivery systems engineered to minimize batch-to-batch variation and lower overall solvent usage.
2. Advanced Chemistries & Modifications
- Macrocyclization Motifs: Pen-Pen disulfides, thioethers, lactams/lactones, hydrocarbon staples, click triazoles, and orthogonal bicyclics.
- Lipation & Acylation: Site-specific C18 diacid fatty acid conjugation (e.g., K37 acylation) for extended half-life and albumin binding.
- Bioorthogonal Linker Chemistries: Site-specific coupling platforms utilizing robust amide, disulfide, thioether, and SPAAC click chemistries for precise conjugate assembly.
- Target Payload Architectures: Advanced ligation strategies for attaching peptide motifs to target payloads, enabling high-yield assembly of PDCs, POCs, PPMOs, ADCs, and AOCs.
- Post-Translational & Unnatural Modifications: Precision incorporation of D-amino acids, N-methylation, PEGylation, and non-canonical side chains to maximize proteolytic stability.
Our Services
Sinopep Biopharma is a trusted full-service Peptide and Oligo CDMO offering comprehensive end-to-end CMC development and commercial manufacturing solutions for global partners.
Peptide CDMO Services
Comprehensive GMP peptide manufacturing services designed to support projects across all stages of development through to full commercialization.
GMP Oligo Services
We provide end-to-end oligonucleotide manufacturing services — from research-grade to clinical-grade — supporting clients across all phases of development.
FTE Services
Our FTE (Full-Time Equivalent) agreements offer a unique approach for long-term peptide and oligonucleotide manufacturing projects involving multiple targets.
Discovery Services
Sinopep's research-grade peptide and oligonucleotide synthesis services are designed to support our clients' discovery efforts. Chemical design services available.
Generic APIs
Sinopep specializes in the development and manufacturing of high-quality peptide, oligonucleotide, and small molecule active pharmaceutical ingredients (APIs).
Formulation
Finished Dosage Form (FDF) Formulation Services. Oral Solid Dosage Form and Lyophilized Powder Injections. Sterile and Non-sterile preparations also supported.
