Oligonucleotide Manufacturing for Clinical Phases
RiboBio’s cGMP manufacturing facility meets or exceeds current IS08, IS07 and IS05 requirements as well as ICH Q7(cGMP) and CFDA Title 21 part 210(cGMP) requirements. To ensure RiboBio continues to meet or exceed these requirements, RiboBio conducts continuous and systematic on-going testing of facilities, water and air supplies, major equipment and in-coming raw materials.
• Validated procedures for the strict qualification of raw materials from reliable, industry-leading suppliers
• Centralized gas supply with on-site purification systems for air and water
• Operating procedures for equipment cleaning, sanitization and validation.
● Development, 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.
● Oligonucleotide drug cGMP production for clinical research
RiboBio has introduced a series of automated oligonucleic acid solid phase synthesizers of different sizes, established a world-class large-scale oligonucleic acid API production line with a maximum single-batch synthesis scale of 1.8M. At present, the facility is able to complete 50g-500g/batch of clinical oligonucleic acid medical products in accordance with GMP requirements, and support Phase I-III clinical research of new nucleic acid drugs. RiboPharm has produced Phase I-III clinical oligonucleic acid products for customers from the US, Australia, Japan and China.
In 2012, RiboPharm established China’s first oligonucleic acid API production workshop in accordance with GMP regulations. It was designed by internationally renowned consultants, and was tested qualified by the design standards of Guangdong Provincial Institute of Drug Control. The production base has obtained the Pharmaceutical Production License issued by CFDA.