From laboratory to GMP production
Asymchem’s oligonucleotide technology platform provides clients with pre-clinical sample preparation, oligonucleotide drug substance and formulation GMP production service. The collaboration of process, analysis, formulation and registration regulations teams provides clients with a fast, efficient, professional and flexible integrated solution for the entire process of oligonucleotide development.
Currently, the Asymchem Oligonucleotide Drug Development Platform team consists of 20 senior oligonucleotide process and analysis experts. More than 80% are masters and PhDs and all our managers have more than 10 years of relevant industry experiences include solid/liquid phase synthesis of large scale of oligonucleotides/ modified oligonucleotides and long chain, chromatography purification, analytical method development and validation.
The scope of services includes:
● Various modified or non-modified antisense oligonucleotides
● RNAi, RNAa
● Morpholine oligonucleotides
● Locked oligonucleotides
● Peptides-oligonucleotide conjugates
● Self-assembled RNA nanoparticles
Advanced facilities and equipment
Our Oligonucleotide Platform is equipped with GE ÄKTA oligonucleotide solid-phase synthesizer and purification equipment from gram-scale to kg-scale. In addition, analytical equipment including Qtof, UPLC-MS, UPLC, GPC and other instruments could provide support for oligonucleotide structure characterization, analysis method development and verification, GMP production IPC control, final product release testing and stability research.
Integrated Platform for Chemical Macromolecule CMC Service
● Integrated experienced team: process, analytical, manufacturing, QC and QA
● Well equipped facilities
● Integrated service scope: peptide, drug linker, oligonucleotides and the conjugates between them
● Reliable and qualified supplier chain management system including self-made synthetic capability of key materials and intermediates
● Strong support from GMP and EHS compliance
Client-Centric Mode and Personal Service
● Project management system and dedicated project team
● Responsiveness to change in project needs
● Shorter lead time
Competitive Cost and High Quality