The facilities of Ribobay can meet the requirements of cGMP regulations of global authorities. Ribobay can provide Non-GMP grade and GMP grade oligo API production services across all stages of drug development, which is "one-stop" service from drug screening to commercialization.
Drug discovery stage
-
● Custom synthesis of candidate molecules for drug screening (nmol - µmol)
High throughput oligonucleotide library synthesis -
● PCC synthesis in preclinical pre-toxicology stage（mg- grams）
Pre-clinial stage
-
● Customized synthesis of toxicology batch samples
2 oligo CMC production lines built to meet the needs of toxicology evaluationBatch size up to hundreds of grams
▶ GMP-Like workshop, laboratory, equipment and instrument
▶ Highly customizable, fast delivery
Clinical oligonucleotides API manufacturing
Our facilities and plants at the oligonucleotide manufacturing site are capable of meeting the requirements of cGMP regulations of NMPA, FDA, EMA, etc,and can provide toxicology batch and clinical research grade oligonucleotide API manufacturing services.
We have automated oligonucleotide synthesis, purification and ultrafiltration facilities of various scales and established large-scale manufacturing lines to provide oligonucleotide APIs manufacturing from gram to kilogram, supporting customers in completing Phase I-III clinical studies.
Commercial oligonucleotides API manufacturing
In compliance with GMP requirements, we have established several automatic oligonucleotide API manufacturing lines, which can not only improve the manufacturing efficiency, but also simplify the control system strategy, reduce the production cost, and meet the cGMP manufacturing requirements.
Equipped with a complete set of Cytiva commercial synthesis and purification equipment, with single batch synthesis scale from 100-1800 mmol; the scale of oligonucleotide synthesis can reach 3.7 mol at the same time, Ribobay meet the commercial needs of oligonucleotides drug and vaccine companies.
