Oligonucleotide Manufacturing


Preclinical Development, Research-Grade


Equipped with 192-channel high-throughput synthesizers (6 units), gram-scale synthesizers (4 units), and dozens of purification devices. Annual delivery: 100,000+ HPLC-purified oligonucleotides for screening and toxicology studies.




GMP Compliance


Passed U.S. FDA cGMP on-site inspections.

Passed 10+ audits by EU, U.S., and Japanese clients.

Quality team: 23 QA + 57 QC (20% of total staff).

Strict adherence to ICH guidelines. API registrations cover China/US/EU/Japan markets.


GMP Facilities and Equipment


Filling&Lyophilization
Filling&Lyophilization
LCMS&HPLC
LCMS&HPLC
NMR
NMR
Purification
Purification
Synthesizer
Synthesizer
UV
UV

EHS System


OHSAS18000 Occupational Health and Safety Certification

Level 3 Safety Standardization Certificate for Hazardous Chemical Enterprises

2021 Sichuan Green Factory Certification

2021 Sichuan "Heavy Pollution Weather Grade B Enterprise" Certification


DCS-SIS
DCS-SIS
Exhaust Gas Treatment System
Exhaust Gas Treatment System
Wastewater Treatment System
Wastewater Treatment System
Fire Linkage Control System
Fire Linkage Control System

Collaborations


Partnered with Guangzhou Bostal to build an "API + Formulation" nucleic acid drug platform. Operational since Q4 2023, serving domestic pharma/biotech companies with 20-30% shorter project timeline.


Case Study


Double-stranded Oligonucleotide PCC-to-IND Integrated Project

With Hitston's technical support, an innovator's double-stranded oligonucleotide project achieved IND-stage delivery within 8 months (PCC to API/formulation). Seamless process development, analytical validation, and GMP production resolved complex molecular challenges, shortening timelines by 20-30% versus industry standards.

Resource Integration: Leverage parent companies' (HitGen, Easton) platforms for rapid execution.

End-to-end Capability: Cover "target screening → process development → production → IND filing" to eliminate technical gaps.

Expedited Delivery: Strict milestone control reduces timelines by 20-30%, helping clients seize market opportunities.

Thanks For Your Interest!


For more details on how we can advance your innovative drug discovery, please contact us.

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