Oligonucleotide Drug Development
API Process Development
Highly Challenging Quality Research
Large-Scale Production Platform
Full Process Breakthrough: Synthesis to Purification
-
•Solid-phase synthesis: Automated processes for efficient synthesis of modified oligonucleotides (thiophosphate, 2'-O-methyl, etc.). -
Liquid-phase synthesis: Ideal for medium/long-chain oligonucleotides and special structures; boosts purity/yield.
-
Purification/QC: HPLC/UPLC platform + MS/CE analytics ensure high purity (>95% typical).
High-difficulty quality research in oligonucleotide drug development
-
Impurity research/QC of phosphoramidite DNA/RNA monomers (cross-protection bases).
-
Structural characterization/confirmation of diverse modified oligonucleotides.
-
Multi-dimensional analytical methods for oligonucleotides.
-
Impurity studies & comprehensive analysis of complex profiles.
-
Oligonucleotide stability studies.
-
Comprehensive research/QC of nucleoside phosphoramidite monomers & solid-phase supports
-
Structural characterization/validation of molecules with varied chemical modifications or coupling sites
-
RP/ion-exchange/size-exclusion chromatography for multi-level purity & related substances study
-
High-res, sensitive, accurate LC-MS + intelligent software for complex sample impurity studies & profile analysis
-
Scientific, compliant long-term/accelerated stability studies & factor influence tests
Accelerate nucleic acid drug commercialization via industry-academia-research collaboration & industrial platforms:
-
Peptide synthesis expertise enables tech transfer
-
Scale-up: mg-level (R&D) to kg-level (GMP commercial) production
-
QC: Compliant with China/US/EU pharmacopoeias; rigorous system (impurity analysis, stability studies)
-
Oligonucleotide API GMP line (clinical to commercial)
-
2024 plan: Dual peptide-oligonucleotide production base (expanded capacity)
