Oligonucleotide Synthesis

CPC offers comprehensive support for complex oligonucleotide production throughout the entire product life cycle, aiming to become the preferred partner for oligonucleotide API development. As customer research and development activities continue to grow, we provide GMP capabilities, process and analytical development, and regulatory support for early-stage projects. Our extensive experience in peptide API development and GMP manufacturing provides a solid foundation for these endeavors.

Since 2022, we have proactively responded to evolving customer demands in the field of oligonucleotides. Currently, we manufacture modified oligonucleotides for both clinical trials and commercial applications. In early 2023, we achieved a significant milestone by successfully completing our first oligonucleotide development project. For more details, please refer to our POC case study [insert link to the case study].

From the discovery to the clinical phases, we provide our clients services for the production of oligonucleotides that are suitable for research and clinical use. We provide contract development and manufacturing of unique oligos, together with scale-up development and analytical testing, using a solid-phase manufacturing technique.

NON-GMP/GMP API OLIGONUCLEOTIDE MANUFACTURING	OLIGONUCLEOTIDE TYPES	MANUFACTURING CAPACITY	ANALYTICAL SERVICES
Over 20 years of solid-phase synthesis experience. ICH Q7, Q8, 9, 10, 11, and 2011 FDA guidance for Process Validation.	ASO, siRNA, miRNA, Aptamer, CpG, Decoy, and most types of modifications including peptide-oligo conjugates (POCs).	CPC has the manufacturing capacity to support your oligonucleotide projects from early discovery (mg quantities) through commercialization (kgs).	Dedicated facility equipment that provide comprehensive analytical services (e.g., structural analysis, endotoxin analysis, ICH Q1, Q2, and Q3).

Our Oligo Capabilities:

We are able to best serve our clients' demands thanks to our great competence in the synthesis of customized oligonucleotides with a variety of modifications. We also offer full internal release testing for standard GMP product requirements.

Synthetic Capabilities

• Quantities from milligrams to multi-kilograms scales

• Purity meet your requirement (80% – 95%)

• Length up to 35nt

• Most types:

  - ASO, siRNA, CpG, miRNA, aptamer
  

• Most Modification:

  - Backbone: PO, PS, PN

  - Base: Base: 2' -OMe, 2' -MOE, 2' -F, 2' -LNA, cEt

  - Conjugate: GaINAc, PEG, Cholesteroal, Peptides (POCs)

• Customized manufacturing model

Purity Requirements

Oligonucleotide:

• ASO

• siRNA

• CpG

• miRNA

• Apatmer

Conjugate:

• Oligo GalNAc Conjugate

• Oligo Cholesterol Conjugate

• PEGylated Oligo

• Oligo Peptide Conjugate

Modifications:

• Backbone: PO, PS, PN

• Base: 2’-OMe, 2’-MOE, 2’-F, 2’-LNA, cEt

What are Oligonucleotides?

Oligonucleotides, commonly referred to as oligos, are short molecular strings composed of building blocks similar to those found in RNA and DNA. They can be single stranded or double stranded, depending on their intended purpose. Different classes of oligos, such as antisense oligonucleotides (ASO) and RNA interference oligonucleotides (RNAi), are named based on their specific mechanism of action.

The building blocks of oligonucleotides consist of three components: a nucleobase, a sugar, and a phosphate. These components can be modified synthetically, allowing for the creation of modified oligos. The modifications can range from minor alterations in a few points to complete changes in a structural element.

Quality Control and Stability

As a pioneer in the production of late-phase and commercial oligonucleotides, CPC is aware of the significance of quality control testing in every aspect of your project. The cGMP testing of raw materials, intermediates, and crude API, including duplexes and conjugates, is done by our quality control group. To support your API, we also process micro risk assessments and ongoing microstudies. For your product, our experts can assist you in creating a thorough stability study that complies with regulatory requirements.

QC AND STABILITY TESTING TO MEET YOUR CMC NEEDS	IN-PROCESS AND RELEASE TESTING	MICROBIOLOGY SUPPORT	COMPREHENSIVE STABILITY STUDY SERVICE	REFERENCE STANDARD TESTING
Our Quality Control group has the expertise and resources you need to keep your project on track.	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.	We perform environmental sampling and monitoring of the in-house purified water system and the manufacturing areas.	We have qualified on-site and off-site ICH sample storage to meet a range of temperature and humidity requirements.	CPC provides complete solutions for your reference standard's needs.