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API-Oligo

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Oligonucleotide CMC

Oligonucleotide Discovery

Oligonucleotide CMC

Oligo Monomer & Ligand

API-Oligo

API-Oligo

Drug Product

Analytical

API-PMO

CMC-Filing

Our oligonucleotide API process development and manufacturing platform provides one-stop solution from preclinical to commercial from one site in Changzhou, China.  We have built industry-leading capability and capacity to support your needs across all development stages, with knowledge retention through the product life cycle.  In addition, Changzhou site is within 1-hour drive from DP site in Wuxi city, enabling faster, simpler and more cost effective oligo CMC development for both API and drug product.  

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Process Development

A highly experienced oligo R&D team with a few hundreds of scientists with 100+ projects completed

  • Cover molecule types of ASO, siRNA, Aptamer, Oligo conjugates, PMO and PPMO

  • Utilize various modified monomers (2'-H, 2'-OH, 2'-F, 2'-OMe, 2'-OMOE, LNA, cEt, LNA, Vinyl-phosphate, Spacer,…)

  • Chiral oligo synthesis

  • Modification at 3'-end or 5'-end with GalNAc, triphosphate, cholesterol, saccharides, peptides, maleimide… 

Manufacturing Capacity

With our global standard quality system, we are uniquely positioned to be your strategic manufacturing partner for reliable, cost effective and long-term supplies of your oligonucleotide APIs from mmol to mol. Our unique "one-site" platform ensures knowledge retention and seamless scale up throughout your product life cycle, and expediates your development by eliminating the trouble of multi companies/sites transfer.

Oligoprocess

Capacity Expansion Plan

Currently we have 4 middle-scale lines, 6 large-scale lines with 6 mol total capacity per synthesis run. By 2023, we will add more middle-scale line and large-scale lines with ~10 mol total capacity per synthesis run.

Key Equipment

  • Synthesis

    OligoPilotTM100

    OligoPilotTM400

    OligoPilotTM2000

    OligoProcessTM

  • Purification

    Hipersep®

    Hipersep® Pilot

    ÄKTAProcessTM

    ÄKTA BioProcessTM

  • UF / DF / TFE

    UniFluxTM 10

    UniFluxTM 120

    Thin Film Evaporator

  • Lyophilization

    Tray Lyophilizers

    0.5 m2 - 20 m2

Access to new technologies

The traditional oligo development and manufacturing process faces many sustainability challenges, such as high waste, poor atom economy and low energy efficiency. 

WuXi STA provides our global customers open access to novel technologies for oligonucleotide development and manufacturing, including the following technologies, toward a greener, more efficient and cost effective process.


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