Overview

The field of oligonucleotide-based therapeutics has rapidly matured, transitioning from a niche research area to a powerful modality poised to treat a vast array of diseases, from genetic disorders to chronic conditions. As a class of single- or double-stranded synthetic nucleic acid polymers, oligonucleotides function by precisely binding to target RNA or DNA to modulate gene expression, offering an unprecedented level of therapeutic specificity. CD BioGlyco's focus is not merely on manufacturing, but on engineering scientifically sound, robust, and scalable processes that de-risk your program from discovery through late-stage clinical trials. We turn complex synthesis challenges into high-yield processes and unstable drug candidates into market-ready formulations.

Core Technologies

• Specialized Synthesis & Modification Chemistry
  We excel in handling the most advanced oligonucleotide chemistries critical for enhanced stability and efficacy:
  • Next-Generation Backbones
    Expertise in developing processes for locked nucleic acids (LNA) and other constrained molecules, including the complex LNA alkyl phosphorothiotriester backbones, which are promising for developing charge-neutral, highly potent splice-switching oligonucleotides (SSOs). Our process development focuses on defining precise solid-phase synthesis conditions to ensure successful coupling and minimize side reactions.
  • Conjugation Chemistry
    Robust process development for therapeutic conjugates, including N-acetylgalactosamine (GalNAc) ligands, which are essential for targeted delivery to the liver, enhancing efficacy and minimizing off-target effects.
• High-Resolution Purification Methodologies
  The purity of the oligonucleotide active pharmaceutical ingredient (API) is paramount. We develop state-of-the-art purification processes that guarantee the removal of critical impurities:
  • Ion-Exchange Chromatography (IEX)
    The primary method for separating full-length product from challenging length-based impurities. Our process development optimizes column loading, mobile phase composition (pH, salt gradients), and elution profiles to maximize purity and yield simultaneously.
  • Ion-Paired Reversed-Phase HPLC (IP-RP-HPLC)
    Essential for removing lipophilic impurities, including protecting groups and residual reagents, and for separating products with differential hydrophobicity, such as those with specific chemical modifications or non-polar counter-ions.

From Synthesis to Solution: Precision RNA Process & Formulation.

Our methodology for RNA therapeutic development initiates with a rigorous optimization of the solid-phase synthesis cycle. We systematically calibrate coupling efficiencies, phosphoramidite selections, and deprotection conditions to maximize yield and crude purity. Subsequently, we employ a design of experiments approach to characterize and optimize our chromatographic purification processes, establishing a robust design space where critical process parameters for impurity clearance are definitively mapped. Following API isolation via ultrafiltration/diafiltration, we conduct comprehensive pre-formulation studies, profiling the isolated compound's solubility, stability, and polymorphic behavior to guide formulation design. We then execute rapid, parallel formulation screens, evaluating diverse buffer systems, excipients, and pH ranges under accelerated stress conditions to identify lead candidates that confer maximal stability. Our process culminates in extensive robustness testing—evaluating LNP shear sensitivity, hold times, and temperature excursions—to generate a complete, scalable technology transfer package for manufacturing.

Workflow

Publication Data

Applications

• Enabling Preclinical Evaluation
  It enables the production of sufficient, high-quality drug substance and a stable drug product necessary for safety testing.
• Optimizing Synthetic Efficiency and Purity
  It focuses on refining the chemical synthesis and purification processes to maximize yield, purity, and cost-effectiveness of the oligonucleotide active ingredient.
• Solving Drug Delivery and Stability Challenges
  It develops advanced formulations and chemical modifications to protect the drug from degradation and ensure it reaches its intended target within the body.
• Facilitating Regulatory Approval
  It generates the necessary data and process understanding to demonstrate control, consistency, and product stability for regulatory submissions.
• Technology Transfer and Scale-Up Support
  It creates a robust and well-documented manufacturing process that can be successfully transferred to a commercial production facility.
• Developing Patient-Centric Drug Products
  It designs final dosage forms that are stable, convenient to administer, and suitable for the intended clinical use, improving compliance.

Advantages

• Integrated Process and Formulation Development
  Unlike fragmented providers, we house both chemical synthesis process expertise and advanced drug product formulation capabilities under one roof. This minimizes the risk inherent in tech transfer and ensures formulation decisions are compatible with manufacturing scalability.
• Novel Delivery Expertise (Oral & LNPs)
  Our proven ability to develop bio-enabling oral formulations using key permeation enhancers and our deep experience in stabilizing complex lipid nanoparticle (LNP)-based products (which often suffer from shear and freeze-thaw sensitivity) set us apart.
• Chemistry-Driven Scalability
  We don't just solve problems; we define scalable processes. Our development of purification methods for complex LNA-modified oligonucleotides, which are challenging to synthesize and separate, ensures your molecule's quality is maintained from the milligram to kilogram scale.
• Regulatory-Focused Documentation
  Every development report is written by our team of experts with a clear focus on your requirements, streamlining your path to filing and clinical progression.

Frequently Asked Questions

Customer Review

• "Our LNP product was highly shear-sensitive. CD BioGlyco's formulation team redesigned our fill-finish process to prevent shear-induced aggregation, and their lyophilization cycle optimization delivered a rock-solid cake with over 24 months of projected stability."

— Manager, Drug Product Manufacturing Group.

• "The CD BioGlyco team took on our complex GalNAc-conjugate project after two other CDMOs struggled with purification. Their ion-exchange chromatography expertise achieved the 98% purity we required."

— Dr. K., Head of Process, Biotechnology Department.

• "We partnered with CD BioGlyco for the seemingly impossible—oral delivery of our ASO. Their innovative use of permeation enhancers in a pulsed-release solid dose formulation delivered the bioavailability data needed to justify advancing the program. Exceptional scientific partnership"

— Director of Research, Pharmaceutical Sciences.

Associated Services

Through our oligonucleotide drug process and formulation development service, we establish robust manufacturing platforms for nucleic acid therapeutics. This expertise extends to our comprehensive Pharmaceutical and Biological Analysis Service, encompassing rigorous Analytical Testing, Biological Evaluation, and Excipient Characterization to ensure product quality and regulatory compliance.

CD BioGlyco is the trusted partner for oligonucleotide development, offering comprehensive process optimization, state-of-the-art purification, and cutting-edge formulation expertise across all dosage forms—from complex sterile liquids and lyophilized products to enabling novel oral solid doses. We invite you to leverage our deep scientific knowledge and advanced platform to accelerate your oligonucleotide program. Our team is ready to provide tailored technical strategies and detailed proposal packages based on your specific molecule and targets. Contact us!