Quality Control Methods for Process Development
RiboBio has established a world-class quality control system for the production process of single-chained and double-stranded oligonucleic drugs, CPG, siRNA and chemical modification, and has formed a complete quality control technology standard.
● Solid-phase synthesis process: Online detection of light absorption, flow rate, system pressure, and conductivity change indicators, and real-time monitoring of the reaction of each synthesis cycle, will ensure a smooth reaction process.
● Ammonia/deprotection process: The control of reaction end point is achieved through the monitor of high performance liquid chromatography (HPLC), ultra high pressure liquid chromatography (UPLC), mass spectrometry (MS), and ultraviolet absorption (UV) of the mother liquor.
● Purification and refining process: To confirm the structure and purity of the target after the product fractions has been detected by HPLC, UPLC, MS and UV, and to serve as a refernce to the mixed sample of the final product.
● Desalination process: The product is detected by conductivity, HPLC, UPLC, MS, and UV detection to monitor the desalination process.
● Annealing process: The mixing ratio of two single chains is monitored by size exclusion chromatography (SEC) to ensure that the double strands form a 1:1 ratio.
RiboBio also provides development and validation services for nucleic acid drug analysis methods such as product purity, solvent residues, heavy metals, stability, moisture detection, microbial and endotoxin testing.