API Solutions

Oligonucleotides

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From Laboratory to GMP Production

Asymchem’s oligonucleotide technology capabilities provide clients with full services in drug substance, from process development through oligonucleotide GMP manufacturing, and drug product, from pre-formulation development through fill-finish. The process chemistry, analytical, formulation, and regulatory teams collaborate to provide clients with a fast, efficient, and flexible integrated solution for oligonucleotide development and manufacturing.

Our oligonucleotide platforms are equipped with advanced technologies including GE ÄKTA oligonucleotide solid-phase synthesizer and purification equipment from gram to kg-scale. In addition, analytical equipment including Q-TOF, UPLC-MS, UPLC, GPC, and other instruments can provide support for oligonucleotide structure characterization, analytical method development and validation, final product release testing, and stability research.

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Service Offerings

  • Various modified or non-modified antisense oligonucleotides
  • RNAi, RNAa, mRNA
  • Morpholine oligonucleotides
  • Locked oligonucleotides
  • Peptides-oligonucleotide conjugates
  • Self-assembled RNA nanoparticles

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Advantages

  • Integrated experienced team: process development, analytical, manufacturing, QC and QA
  • Well-equipped facilities, high capacity (gram – kilogram scales)
  • Reliable and qualified supply chain management system, including the ability to internally manufacture many key raw materials and intermediates. Learn about our Supply Chain here.
  • Drug Substance and Drug Product manufactured in a single facility to minimize the need for a knowledge transfer between sites when moving from discovery to development to commercialization.
  • GMP compliant manufacturing in an FDA inspected facility  Link to Compliance
  • Adhere to strict EHS compliance
  • Project management system and dedicated team for your individual project
  • Responsiveness and flexibility to change in project needs
  • Competitive lead times
  • Always investing in development and new technologies. Ongoing projects include the implementation of state-of-the-art instrument platforms, novel approaches to chemistry (including liquid phase synthesis) and the latest in conjugation moieties being investigated and used in drug development.
  • Link to brochure