Oligonucleotide Manufacturing for Commercial Phases

RiboBio is widely praised by customers for its experience in oligonucleotide-based CMC services – Chemistry, Manufacturing and Control. In 2013, RiboBio became the first to establish a large-scale oligonucleic acid cGMP manufacturing workshop in China; in 2016, it obtained the CFDA-issued API production license; in 2018, it completed the construction of the workshop, and the facility will be launched in 2019 for 1800nmol mass synthesis per batch and 1kg-40kg lyophilization, meeting the commercial production requirements of APIs above the kilogram level. RiboBio also provides process validation, analytical methods, quality assurance and risk management.

●   Mass production process transfer, certification and verification

●   Transfer and verification of analytical methods

We develop analysis methods for product purity, related substances, water constituent, elemental impurities, sodium salts, residual solvents, contents, microbial limits, and bacterial endotoxin in different oligonucleotide products according to customer requirements, and verifiy these analytical methods to make them truly meet nucleotide and drug testing and quality control requirements. We also transfer these methods to customers based on pharmacopoeia requirements for further optimization and verification.

●   Commercial oligonucleotide-based drugsc GMP manufacturing

RiboBio has introduced an automated oligo synthesis platform for the large single-batch synthesis, and established a world-class oligonucleotide API production line according to GMP requirements, with a synthesis scale at 1.8M and 40kg oligonucleotide API in a single batch.

In 2012, RiboBio established China’s first oligonucleotide API base under cGMP condition. It was designed by globally renowned consultants, and was qualified by Guangdong Provincial Institute of Drug Control. The production base has obtained Production License issued by CFDA.

●   cGMP Quality Management System
●   Project & Risk Management
●   Facility verification