Oligonucleotide NCEs
Large-Scale Production and Development of ASOs, siRNA, and PMOs
OLIGO Services
Oligo CDMO for NCE Development and Commercial Production
As a dedicated oligonucleotide CDMO, Sinopep has reached key milestones in oligo development, successfully synthesizing a variety of oligonucleotide types, including ASOs, siRNA, and PMOs. With a recent expansion in production capabilities, Sinopep now offers an annual manufacturing capacity of 1,000 kg of oligonucleotides, 100 kg of PMOs, and 200 kg of peptide-oligo conjugates.
Inside Our New GMP Oligonucleotide Manufacturing Facility
A closer look at our state-of-the-art facility in Jiangsu Lianyungang
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.
Complete Lifecycle Support
Our comprehensive oligonucleotide platform provides end-to-end CMC support, mitigating risk and ensuring seamless scalability at every stage of development. The table below details our phase-specific activities across discovery, preclinical IND-enabling studies, and clinical manufacturing:
| FUNCTION | KEY ACTIVITIES |
|---|---|
| Preclinical Phase | IND-Enabling Oligo Development |
| Sequence & Backbone Selection | Screening modified bases, backbone chemistries (PS/PO), and conjugation strategy (e.g., GalNAc, lipid). |
| Solid-Phase Synthesis & Upstream | Phosphoramidite quality evaluation, coupling yield optimization, and gram-scale solid-phase synthesis. |
| Downstream & Analytical Setup | Cleavage/deprotection (C&D) screening, crude IP-RP-HPLC/IEX purification, and MS sequence confirmation. |
| IND-Enabling CMC Support | Impurity profiling ($(n-1)$, shorters, depurination), forced degradation, and initial IND CMC package. |
| Clinical Phase I | Early Clinical Manufacturing |
| GMP Upstream & Cleavage | Tech transfer, synthesis column loading strategy, GMP amidite sourcing, and controlled C&D execution. |
| GMP Downstream & Desalting | Preparative HPLC/IEX purification, ultrafiltration/diafiltration (UF/DF) desalting, and lyophilization. |
| Analytical Release & Characterization | HRMS sequence mapping, free amidite/solvent residual testing, elemental analysis, and GMP release. |
| Clinical Phase II | Process Characterization & Control |
| Synthesis Optimization & QbD | Deblock, coupling, capping, and oxidation/sulfurization efficiency DoE studies to map CQAs. |
| Purification & Conjugation Scale-Up | Large-scale column chromatography optimization, conjugation reaction yield, and impurity purge studies. |
| Reference Standards & Stability | Primary oligo reference standard qualification, formal ICH stability, and Phase II CMC package. |
| Clinical Phase III | Registration Readiness |
| Commercial Process Lock | Final scale-up lock for synthesis cycles, C&D parameters, resin reuse limits, and Master Batch Records. |
| Analytical Validation | Validation of IP-RP-HPLC/IEX purity assays, HRMS identity, bioburdens/endotoxins, and ICH Q2 methods. |
| Regulatory & Raw Material Security | Phosphoramidite and solid support supply chain qualification, CTD Module 3, and NDA/MAA filing. |
| Commercialization | Process Validation & Launch |
| Process Performance Qualification | PPQ batch execution (≥3 consecutive campaigns), impurity carryover monitoring, and CQA verification. |
| Commercial Supply & Testing | Routine GMP release, lyophilization site qualification, supply chain management, and launch readiness. |
| Lifecycle Management | Post-approval continuous process verification (CPV), synthesis yield optimization, and regulatory updates. |
Years Experience
Employees
GMP Oligo Projects
GMP Faclities
State-of-Art Equipment
Our advanced oligonucleotide platform integrates state-of-the-art synthesis equipment, versatile conjugation technologies, and a strong manufacturing infrastructure to deliver high-quality products with exceptional consistency. Using industry-leading OligoSynt systems, we support a broad range of complex conjugates—including PPMO, POC, AOC, GalNAc-oligos, and antibody-oligo formats—providing flexible solutions for diverse therapeutic needs. With robust production capacity and deep technical expertise, we help accelerate oligonucleotide programs from early development through advanced stages.
| Instrument | Process | Scale / Flow Rate | Application |
|---|---|---|---|
| Cytiva OligoSynt | Synthesis | 10 µmol to 180 | Discovery (in vitro and host-cell–based screening of drug candidates) |
| Cytiva OligoPilot | Synthesis | 10–50 µmol (small range); 50 µmol–9 mmol (large range); up to 10–100 mmol | Pre-clinical, toxicology studies, early clinical (Phase 1/2) |
| Cytiva OligoProcess | Synthesis | 10–1800 mmol (up to 2 mol) | Late-stage clinical (Phase 3) and commercial manufacturing |
| ÄKTA Avant 150 | Purification | 120 mg ~ 6.0 g / 0.01–150 mL/min | Research, process development, and small-scale/pre-clinical purification |
| ÄKTA Process | Purification | 1–2000 L/h (ranges: 1–180, 3–600, 10–2000 L/h) | Pilot to mid-scale clinical and commercial oligonucleotide purification |
| ÄKTA Bio-Process | Purification | 1 to 12,000 L/h | Large-scale commercial manufacturing of approved oligonucleotide therapeutics |
| Cytiva Uniflux 30 | Ultra-Filtration | 3–60 L/min | Concentration and buffer exchange for pre-clinical and early clinical batches |
| ÄKTA Flux | Ultra-Filtration | Up to 100 mL/min (s); up to 500 mL/min (6); permeate 1–50 mL/min | Lab-scale and pilot TFF, process development, and small clinical batches |
| Cytiva Uniflux 400 | Ultra-Filtration | Up to 400 L/min (custom high-flow) | Large-scale concentration, diafiltration, and formulation of commercial oligonucleotide drug substance |
Oligo Drugs Currently in Development at Sinopep
Advancing Antisense Oligonucleotides (ASO) and Small Interfering RNA (siRNA) Therapies.
At Sinopep, we are actively developing a pipeline of oligonucleotide-based therapeutics, focusing on antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs). These advanced modalities enable precise gene silencing and modulation, offering promising treatments for a range of genetic, rare, and complex diseases. Leveraging our expertise in oligonucleotide synthesis and manufacturing, we deliver high-quality, scalable solutions to support partners from preclinical stages through clinical development.
| Project Code | Project Type | Drug Class | Status |
|---|---|---|---|
| AT008 | CDMO (ANDA) | siRNA | Process development and optimization |
| AT017 | CDMO (ANDA) | siRNA | Process development (Lab scale) |
| AT018 | CDMO (ANDA) | siRNA | Process development (Lab scale) |
| AT019 | CDMO (ANDA) | siRNA | Process development (Lab scale) |
| AT030 | CDMO (NDA) | siRNA | Toxicology batch |
| AT041 | CDMO (NDA) | siRNA | Process development (Lab scale) |
| AT005 | CDMO (ANDA) | ASO | Engineering batch |
| AT003 | CRO | ASO, vaccine adjuvant | Process development (Lab scale) |
| AT035 | CRO | ASO, vaccine adjuvant | Process development (Lab scale) |
| AT037 | CRO | ASO, vaccine adjuvant | Process development (Lab scale) |
