Oligonucleotide CDMO
Oligonucleotide therapeutics have emerged as a powerful class of precision medicines with applications in genetic diseases, oncology, metabolic disorders, and emerging RNA-based therapies. However, successful development of oligonucleotide drugs requires integrated expertise across molecular design, synthesis process development, drug substance manufacturing, formulation development, and analytical characterization. Protheragen provides comprehensive oligonucleotide CDMO services supporting the development and manufacturing of diverse nucleic acid therapeutics, including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), phosphorodiamidate morpholino oligomers (PMOs), CpG oligonucleotides, and RNA-based therapeutics.
Overview of Oligonucleotide CDMO
Oligonucleotide drug development involves a complex multidisciplinary workflow that requires coordinated optimization of molecular design, chemical synthesis, purification processes, formulation strategies, and quality evaluation. Compared with conventional small molecule therapeutics, oligonucleotide medicines present unique development challenges, including sequence-specific properties, chemical modification requirements, delivery limitations, and manufacturing complexity.
A successful oligonucleotide development program requires a seamless transition from discovery to manufacturing. Early-stage sequence optimization and conjugation design influence downstream process development, while robust analytical strategies and scalable manufacturing processes are essential for clinical translation.
Fig.1 Delivery of oligonucleotide‐based therapeutics: challenges and opportunities. (Hammond, S.M., et al., 2021)
Our Services
A multi-dimensional evaluation framework covering post-translational modifications, physicochemical properties, and molecular stability - providing a complete picture of candidate developability.
Early-stage design and optimization are critical for developing effective and manufacturable oligonucleotide therapeutics. Protheragen supports sequence design, candidate evaluation, and conjugation strategy development to improve therapeutic potential and development feasibility.
A thorough understanding of molecular properties provides essential information for downstream process development and quality control. Protheragen provides customized process development solutions to establish robust and scalable manufacturing processes for oligonucleotide therapeutics. Our capabilities include solid-phase synthesis optimization, CMC process development, and modality-specific process strategies for ASO, siRNA, PMO, and CpG oligonucleotides.
Protheragen offers integrated drug substance development and manufacturing support, including oligonucleotide API development, manufacturing process optimization, and RNA drug substance production. Our solutions help establish reliable production processes and ensure consistent quality for clinical-stage oligonucleotide programs.
Protheragen provides formulation development and manufacturing solutions to transform oligonucleotide drug substances into stable and clinically suitable drug products. Our expertise covers injectable formulations, lyophilized products, and advanced lipid nanoparticle (LNP)-based delivery systems.
Protheragen delivers comprehensive analytical characterization and stability evaluation services to support oligonucleotide quality assessment throughout development. Our analytical strategies cover starting materials, process intermediates, drug substances, and drug products to ensure product understanding and development readiness.
Oligonucleotide Modalities Supported
Protheragen supports a broad range of oligonucleotide platforms, providing customized development strategies according to molecular characteristics and therapeutic objectives.
| Modality |
Applications |
| Antisense Oligonucleotides (ASOs) |
Gene regulation, RNA modulation, rare genetic diseases |
| siRNA Therapeutics |
Gene silencing, RNA interference therapies |
| PMO Therapeutics |
Splicing correction and genetic disease applications |
| CpG Oligonucleotides |
Immune activation and vaccine-related applications |
| RNA Therapeutics |
Emerging nucleic acid medicines and delivery platforms |
Support Across Oligonucleotide Development Stages
Protheragen supports oligonucleotide programs throughout the development lifecycle, providing flexible CDMO solutions from early discovery to clinical-stage manufacturing.
| Development Stage |
CDMO Support |
| Discovery & Design |
Sequence optimization, candidate evaluation, conjugation strategy development |
| Preclinical Development |
Process feasibility assessment, analytical characterization, formulation screening |
| CMC Development |
Synthesis optimization, purification development, manufacturing process design |
| Clinical Development |
Drug substance production, drug product manufacturing, stability studies |
| Late-stage Development |
Process optimization, analytical support, manufacturing readiness |
Why Choose Us
- Integrated Oligonucleotide Development Platform
Protheragen provides end-to-end oligonucleotide CDMO solutions covering discovery, process development, manufacturing, and analytical support.
Experience across multiple oligonucleotide platforms enables customized development strategies for diverse therapeutic programs.
Integrated process development, drug substance manufacturing, drug product development, and analytical capabilities support efficient program advancement.
- Flexible Development Solutions
Customized project strategies are designed according to molecular characteristics, development stage, and manufacturing requirements.
- Scientific and Technical Expertise
Our multidisciplinary team supports partners in overcoming challenges associated with oligonucleotide development and manufacturing.
The future of precision medicine depends on reliable and scalable development platforms for complex nucleic acid therapeutics. Protheragen combines expertise across oligonucleotide design, process development, manufacturing, formulation, and analytical evaluation to support innovative drug development programs. Through integrated CDMO solutions, we help partners transform promising oligonucleotide candidates into clinically advanced therapeutic products. Contact us to discuss your oligonucleotide development requirements, including sequence design, process development, manufacturing, formulation, and analytical solutions.
Reference
- Hammond, S.M., et al. "Delivery of oligonucleotide‐based therapeutics: challenges and opportunities" EMBO Molecular Medicine, 2021, 13.
