CDMO Services
Scope of Services
Scope of Services
Business Field
Small molecule chemical APIs mRNA materials
Research & Development
Design, screen and optimize synthesis route, patent challenges, comprehensive quality studies
Manufacturing
Clinical sample preparation, lab scale-up, pilot and process validation, commercial supplying
Regulatory
Provides regulatory affairs services in China, the United States, Europe and Japan
Technical Capability
Technical Capability
Production Lines
18 regular production lines, 6 independent lines for high potency and cytotoxic APIs DCS-SIS system, with dangerous reaction capabilities including hydrogenation, oxidation, chlorination, sulfonation, diazotization and alkylation
Capability of high pressure, high temperature, cryogenic reaction conditions Pressure range: 0~8MPa, temperature range: -100 ℃~250℃
Quality System
cGMP site inspection and approval by NMPA and USFDA;
Customer audits from Europe, USA and Japan.
Technology Platform
Asymmetric synthesis
Transition metal catalysis
Enzyme catalysis
Micro-channel continuous reaction
Project Experience
Experienced in patent challenging on crystalline form & synthesis process
Experienced in synthetic route development and scale-up & quality research
International Registration
Experienced regulatory affairs team;
Obtained 3 CEPs, 3 JDMFs, and 5 US DMF/VMFs
Testing Instruments
HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc.
