Oligonucleotide Conjugate API
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When your oligonucleotide conjugate drugs enter preclinical phase, the challenges come up as your synthesis methodology or conjugation techniques probably do not serve scale-up or first-in-human needs.
WuXi TIDES is well positioned to provide a one-stop solution for complex oligonucleotide-conjugate drugs from discovery to development and commercial manufacturing, with our strong capabilities in both oligonucleotide, peptide and small molecules including ligand, toxin, linker, lipid, PEG etc. Supported by readily scalable facilities, we provide integrated CMC service and highly reliable solutions to develop and manufacture oligonucleotide APIs and all common ligands, together with the conjugation chemistry to streamline your projects from your preclinical studies to clinical trials. Our dedicated teams greatly reduced the time for CTM batch and complexity of material transfer.
The ligands we support
- Peptide
- Lipid
- GalNAc
- Cholesterol
- PEG
Linker chemistry
- Amide coupling
- Thiol-maleimide addition
- Click chemistry (CuAAC | SPAAC)
- Broad selection of spacers
- Custom-tailored linkers
Topology
- 3'- or 5'-conjugation
- Complex dual conjugation: 3’,5’- | 3’,3’- | 5’,5’-
- Multi-valency: Mono- | di- | tri- | tetra
Case study: Accelerated timeline to IND for Peptide-PMO based therapeutics
We successfully enabled IND filing of a Peptide-PMO conjugate (PPMO) project within 11 months by seamless collaboration with in-parallel activities among 6 teams. PMO stands for phosphorodiamidate morpholino oligomers. Please refer to PPMO page here for more details.
Peptide-Phosphorodiamidate Morpholino Oligomers (PMO)
WuXi TIDES provides Phosphorodiamidate Morpholino Oligomers (PMO) process development and manufacturing services from pre-clinical to commercial in Changzhou, China, the same site as our peptide CMC teams. Leveraging our know-how together with our proprietary (patented) solid support, cleavage and deprotection process as well as customized reactors, we can manufacture PMO efficiently from gram scale to multi-kilogram scale with high quality.
Leveraging our peptide manufacturing from one site in Changzhou, China, WuXi TIDES can also produce peptide-PMO (PPMO) with streamlined process. PMO and PPMO development and manufacturing are supported by our in-house comprehensive analytical, project management, as well as CMC regulatory teams. To date, we have completed dozens of PMO projects including 10+ PPMO projects.
