Danaher Life Sciences Salon: Modification, Delivery, and Process Development of Nucleic Acid Drugs

Domestic misconceptions exist regarding the field of oligonucleotides. In terms of molecular weight, oligonucleotides fall between small molecules and large molecules. Compared to traditional small molecule drugs or antibody drugs, nucleic acid drugs may appear to have simpler preparation processes, but there are significant differences at each stage.

Veliter Biomedical Technology Company, established in July 2019, specializes in the development (AD), process development (PD), and GMP production of oligonucleotides, with an annual production capacity of 15 to 20 kilograms.

Time is money. Early-stage AD and PD implementation are crucial for controlling impurities, establishing analytical methods, and optimizing processes, which is markedly different from small molecules. For example, in synthesis, if purification is only performed after synthesis, sometimes it may be an impossible task.

In the early stages, the goal of R&D is to obtain a product, whereas the concept shifts entirely in PD. All synthesis data obtained in R&D become meaningless in PD, which is a significant difference from small molecule and antibody drugs. The characteristic of the oligonucleotide field is that the R&D process is rapid, but once it comes to filing, there is often insufficient time for PD, requiring more time and effort.