Our oligonucleotide API process development and manufacturing platform offers comprehensive services,  from preclinical to commercial stages. We’ve established industry-leading capabilities and capacities to support your needs across all development stages, ensuring knowledge retention throughout the product lifecycle. Moreover, our drug product site in Wuxi City, China is with 1-hour drive from the API site in Changzhou, China, enabling a faster, easier, and more cost-effective oligonucleotide CMC development for both API and drug product.

We support various oligonucleotide modalities, including but not limited to:

  • DNA | ASO | PMO
  • miRNA | siRNA | sgRNA
  • Aptamer
  • Various Sugar / Backbone Modified Oligonucleotides

Process Development

We have a highly experienced oligonucleotide R&D team comprised of several hundred scientists. 

Manufacturing

We provide reliable and robust supplies of your oligonucleotide APIs, ranging from millimoles to moles. Our unique CRDMO platform ensures knowledge retention and seamless scale-up throughout your product’s life cycle. Furthermore, we expedite your development by streamlining cross-functional teams during different stages including API, drug product, analytical and regulatory dossier preparation.

We operate approximately 30 oligonucleotide manufacturing lines at various scales, including 4 large-scale lines (OligoProcess™) at our site in Changzhou, China. Additionally, we are planning to add more lines at Taixing & Singapore site.

Experience Highlights: For a commercial manufacturing project, we successfully completed 100 batches of 900 mmol DNA production. This included PPQ enabling studies and PPQ campaigns, resulting in the delivery of more than 400kg of product within a span of 9 months.

Case Study: Accelerate Commercial Manufacturing of an Oligonucleotide with WuXi Speed.

Changzhou Site, China

Taixing Site, China

Key Equipment

Synthesis

Purification

UF / DF / TFE

Lyophilization

Access to New Technologies

Traditional oligonucleotide development and manufacturing processes often face sustainability challenges, including high waste, poor atom economy, and low energy efficiency. At WuXi TIDES, we provide our global customers with open access to innovative technologies for oligonucleotide development and manufacturing. These technologies aim to foster a greener, more efficient, and cost-effective process.

Liquid Phase Oligonucleotide Synthesis

Biocatalysis

Thin Film Evaporation

Spray Dried Dispersion

API in Solution

Continuous Purification

Liquid Phase Oligo Synthesis

Biocatalysis
 

Thin Film Evaporator

Spray Dried Dispersion

Isolate API Solution

Continuous Purification

Phosphorodiamidate Morpholino Oligomers (PMO)

Phosphorodiamidate Morpholino Oligomers (PMO) are a type of oligonucleotide molecule. These short, single-stranded DNA analogs are built upon a backbone of morpholine rings connected by phosphorodiamidate linkages. Although they are routinely used for gene silencing and have been developed into excellent antisense reagents in PMO-based drugs, synthesizing PMO remains a challenging task.

At WuXi TIDES, we have developed a high loading solid-phase PMO synthesis process. This process achieves over 50% yield, over 75% crude purity, and more than 90% final product purity with less than 0.045 EU/mg endotoxin. Our chemistry know-how allows us to make various PMO 5′ modifications with an improved cleavage & de-protection process. 

To support large-scale production, we have customized PMO synthesis reactors up to 100L. Our team has successfully completed PMO development and manufacturing projects on a kilogram scale.

ppmo img API

Our oligonucleotide and peptide API platforms are both located at our site in Changzhou, China. This strategic location is well-suited for the development and manufacturing of oligonucleotide and peptide conjugates, especially Peptide-PMO (PPMO). To date, our team has successfully completed dozens of PPMO projects. The following case study illustrates how our cross-functional teams seamlessly collaborate with in-parallel activities, providing a fast, efficient, and flexible solution for PPMO development.  Learn more from our case study video here.

Case Study: IND Ready in 11 Months for a PPMO Drug Candidate

IND Ready in 11 Months for a PPMO Drug Candidate
Oligonucleotide Conjugate

When your oligonucleotide conjugate drugs enter the preclinical phase, you may encounter challenges if your synthesis methodology or conjugation techniques aren’t suitable for scale-up or first-in-human needs.

WuXi TIDES is well positioned to provide a one-stop solution for complex oligonucleotide-base conjugated drugs, from discovery through development to commercial manufacturing. Our strong capabilities extend to oligonucleotides and small molecules, including ligands, toxins, linkers, lipids, PEG, and more. With readily scalable facilities, we offer integrated CMC services and highly reliable solutions for developing and manufacturing oligonucleotide APIs and all common ligands. We also provide conjugation chemistry to streamline your projects from preclinical studies to clinical trials. Our dedicated teams significantly reduce the time required for CTM batches and simplify material transfers.

WuXi TIDES Oligonucleotide API

Ligands

Linker Chemistry

Topology

Case Study: Accelerated Timeline to IND for Peptide-PMO Based Therapeutics

We successfully facilitated the IND filing of a Peptide-PMO (phosphorodiamidate morpholino oligomers) conjugate project within 11 months. This was achieved through seamless collaboration and in-parallel activities among six teams. For more details, please refer to our PPMO page here

PPMO case study API
Amidite Process Development & Manufacturing

Our team has extensive experience customizing over 1,000 amidite molecules, even those with the most challenging structures. This expertise supports your oligonucleotide projects from discovery through development to the commercial stage, including:

In additon to discovery synthesis, we offer amidite process development and manufacturing services, with dedicated plants specifically for amidite production. Besides, we established amidite impurity control strategy by systematically conducting assessment of amidite impurities and their impact on oligonucleotide API quality. During the process, 1,000+ amidite impurities were synthesized.

Among 500+ catalog amidites, we also provide 40+ amidite products available at commercial scale, including DNA, 2’-MOE, 2’-OMe, 2’-F, LNA, PMO monomer, etc. Selected common amidite DMFs available.

Amidite banner2 API

Sample Amidite Molecules

RNAi amidite API

RNAi-Amidite
(2′-F, OMe Moe, OTBS, etc.)

LNA amidite API

LNA Amidite

TNA amidite API

TNA Amidite

Vpm POM API

Vpm-POM

Chiral amidite API

Chiral Amidite

PACE amidite API

PACE Amidite

Thio amidite API

Thio-Amidite

PMO Monomer API

PMO Monomer

GalNAc Process Development & Manufacturing

Our teams have extensive experience in the production of various types of GalNAc molecules, including Mono-GalNAc, Tri-GalNAc, Tetra-GalNAc, GalNAc amidite, GalNAc PFP ester, GalNAc N3, and GalNAc-PEG conjugates, among others. 100+ GalNAc compounds were synthesized
We offer GalNAc custom synthesis, process development, and manufacturing support from the discovery phase through to commercial launch. Our batch scales range from milligrams to over 50 kilograms.

GalNAc development and manufacturing services are provided at our Changzhou site, China. We successfully optimized GalNAc resin loading process, increasing SPOS yield by 50%.

With various GalNAc building blocks and CPG/PS conjugate resins, we are well-equipped to accelerate your GalNAc-oligonucleotide projects.

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