Oligonucleotide-based Drug Manufacturing Process Development

RiboBio has been developing stable, affordable and environmently-friendly oligonucleotide manufacturing process for years, and has accumulated rich experience in nucleic acid drug preparation process and successfully helped customers develop a number of significant processes.

● Rich experience: With more than 14 years of experience in oligonucleic acid synthesis and preparation, the process development team has completed hundreds of thousands of oligonucleic acid production ranging from milligram to kilogram level.
● Globe-leading team: It brings together world-class nucleic acid chemistry profressionals and engineers. The core technicians all have Ph.D or master’s degrees and unique experience in the analysis of key process control points of oligo nucleic acid products, process impurity source and production scale-up.
● Legitimate compliance: Process development and reports are completed according to the requirements of the State Food and Drug Administration and ICH guidelines to support the clinical application of innovative nucleic acid drugs.

Examples

Case 1: Oligo Nucleic Acid Process Development and Process Report

Project Background

An international client entrusted RiboPharm to carry out a clinical-grade nucleic acid new drug production process, which has high requirements on the purity and batch-to-batch difference, and achieves stable amplification to pilot scale, and provides process reports according to FDA requirements.

Solution or results

● Completion of the process development for new oligonucleic acid drugs within project cycle period
● The pilot production scale of three consecutive batches is more than 50g/batch, and all three batches of inspection indicators have reached the quality standard. The batch-to-batch difference of purity is less than 1%, with the difference in the rate of recovery being less than 5%
● Completion of the writing and transfer of the process report required by FDA

Case 2: New Nucleic Acid Drug Process Development and CTD Report

Project Background

A Chinese client asked RiboPharm to develop a production process for a new nucleic acid drug with higher purity requirements to achieve stable amplification to pilot scale, and to assisit CTD application.

Solution or results

● Completion of the process development for new oligonucleic acid drugs within project cycle period
● The pilot production scale of three consecutive batches is more than 50g/batch, and all three batches of inspection indicators have reached the quality standard. The batch-to-batch difference of purity is less than 1%, with the difference in the rate of recovery being less than 5%.
● Completion of the writing and transfer of CTD data for new drug applications