Overview
As a global leader in oligonucleotide CDMO solutions, we provide research-grade and clinical-grade oligonucleotide manufacturing services to our clients spanning from discovery to clinical phases. Using solid-phase manufacturing protocol, we offer contract development and manufacturing of custom oligos, including scale-up development and analytical testing.
Oligonucleotide Types
ASO, siRNA, miRNA, PMO (morpholinos), Aptamer, CpG, Decoy, and most types of modifications including peptide-oligo conjugates (POCs, PPMOs).
Manufacturing Capacity
CPC Scientific has the manufacturing capacity to support your oligonucleotide projects from early discovery through commercialization (kgs).
Analytical Services
Dedicated facility equipment that provide comprehensive analytical services (e.g., structural analysis, endotoxin analysis, ICH Q1, Q2, and Q3).
OLIGONUCLEOTIDE CITATIONS AND PUBLICATIONS
CPC Scientific provides research-grade and clinical-grade Oligonucleotide manufacturing services to our clients spanning from discovery to clinical phases.
Hao, Liangliang, Renee T. Zhao, Nicole L. Welch, Edward Kah Wei Tan, Qian Zhong, Nour Saida Harzallah, Chayanon Ngambenjawong et al. Nature Nanotechnology (2023): 1-10.
All peptides and oligonucleotides were synthesized and HPLC purified by CPC Scientific and Integrated DNA Technologies (IDT), respectively. Peptide–oligonucleotide conjugates were generated by copper-free click chemistry.
Synthetic oligonucleotides constitute an important class of therapeutics developed to treat a variety of indications. Two main synthetic approaches exist for the conjugation of a peptide to an oligonucleotide: parallel and linear. The primary benefit of the linear approach is the one-pot solid-phase assembly and compatibility with machine automation. However, in cases where poor compatibility of peptide and oligo chemistries exist or long peptide and oligo fragments are required, preparing both components separately and linking both compounds together may offer the simplest solution.
Oligonucleotide Synthetic Capabilities
Our strong expertise in the synthesis of custom oligonucleotides with a wide range of modifications enables us to best meet our client’s needs. Additionally, we provide all in-house release testing for typical GMP product specifications.
Synthetic Capabilities
Suggested Purity Levels
| > 80% | > 85% | > 90% |
|---|---|---|
| Single strand RNA | Conjugate modified sequence | Generic siRNA duplex |
| Generic LAN (Locked nucleic acid) | Generic DNA | |
| Batches for toxicology studies | 2′- Modified RNA (OMe, MOE, F) |
WHY CHOOSE CPC SCIENTIFIC?
We understand that there are many peptide CDMO choices in today’s market. Learn more about what separates CPC Scientific from other GMP manufacturers.
Manufacturing Expertise
We have over 20 years of solid-phase manufacturing experience.
- SPPS, LPPS, ligation chemistry and fragment condensation methodologies.
- Innovative purification and isolation techniques employed.
- Process development and scale-up competence ensures a robust commercial process.
- Complex sequences and oligonucleotide modifications adapted to large-scale production.
CGMP Compliance
CPC Scientific’s CGMP program strictly adheres to FDA/EU cGMP guidelines.
- Code of Federal Regulations Part 210/211 (21 CFR 210/211) and
- ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)
Regulatory Support
Complete support for your IND and NDA US and international filings.
- All required regulatory support for your oligonucleotide APIs.
- Phase appropriate control systems consulting
- Information necessary for chemistry, manufacturing, and controls (CMC) compilation for Investigatory New Drug (IND) and New Drug Application (NDA) submissions
- Drug Master File (DMF) compilation and submission
- Annual product reviews
Quick Delivery Time
Delivery time is a critical component of your project’s success. We have the capacity and flexibility to accept new projects and initiate production sooner than many leading oligonucleotide manufacturers.
Manufacturing Capacity
CPC Scientific has the manufacturing capacity to support your GMP projects from early discovery through commercialization (kgs). We also have the flexibility, pre-qualified workspace, and robust supply chain to rapidly incorporate new projects into our production pipeline.
Complete Life Cycle Support
CPC Scientific stands with you at every stage of development including life-cycle support at discovery phase, preclinical development, clinical trials, and commercial manufacturing.
Confidentiality
The satisfaction of our customers is the most important reason for our continued growth and success. One critical ingredient is maintaining the confidentiality of trade secrets and proprietary information released to us by our customers. CPC Scientific will assure the complete confidentiality of all proprietary information we receive during the course of fulfilling any of our custom services.
Proven Track Record
With over 20 years of expertise in peptides, CPC Scientific has a proven track record in custom synthesis, bulk-scale manufacturing, and process development. We have early- and late-phase experience with over 100 projects in clinical development with 9 commercial products.
Quality Control and Stability
As an industry leader in late-phase and commercial oligonucleotide manufacturing, CPC Scientific understands the vital role that quality control testing plays in all facets of your project. Our Quality control group performs cGMP testing of raw materials, intermediates, and crude API including duplexes and conjugates. We also process micro risk assessment and in-process micro studies to support your API. Our experts can help you design a comprehensive stability study to meet regulatory guidelines for your product.
QC and Stability Testing to Meet Your CMC Needs
Our Quality Control group has the expertise and resources you need to keep your project on track.
In-process and Release Testing
Our QC performs all the necessary testing to generate a comprehensive certificate of analysis. We can also test drug products manufactured by a third party.
Microbiology Support
We perform environmental sampling and monitoring of the in-house purified water system and the manufacturing areas.
Comprehensive Stability Study Service
We have qualified on-site and off-site ICH sample storage to meet a range of temperature and humidity requirements.
Reference Standard Testing
CPC Scientific provides complete solutions for your reference standard’s needs.