Oligonucleotide Manufacturing Process Development
Analytical Methods
& Stability Study
Oligonucleotide
Manufacturing for Clinical Phases
Oligonucleotide
Manufacturing for Commercial Phases
Preparation, aseptic filling or
lyophilization
Validation & Quality
Quality Management System
Based on the cGMP requirements of Chinese CMP (2010), ICH Q7, 21 CFR Part 210 & 211 and Part 11, EudraLex – Volume 4, etc, RiboBio has utilized risk management tool while combining with nucleic acid drug production process for clinical research to establish the complete cGMP quality management system.
Our quality management system includes but not limited to:
● Personnel and Training Management
● Material Supplier and Release Management
● Process Control
● Validation of Facility and Equipment Confirmation
● Lab Quality Control
● Product Release Management System
● Deviation, Modification, CAPA, Internal Audit, etc
In 2016, RiboBio obtained China’s first CFDA-approved cGMP oligonucleotide API production license, and has passed over 30 times of GMP audit from global customers.