From Laboratory to GMP Production
Asymchem’s oligonucleotide technology capabilities provide clients with full services in drug substance, from process development through 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.
- Various modified or non-modified antisense oligonucleotides
- RNAi, RNAa, mRNA
- Morpholine oligonucleotides
- Locked oligonucleotides
- Peptides-oligonucleotide conjugates
- Self-assembled RNA nanoparticles
- 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