A new approach to streamlining biologics manufacturing could soon catch on--encoding the therapies in DNA or RNA, which enjoins the patient to produce the proteins in vivo. While the biggest upside may be the speed and low cost of production, as the first encoded biologics begin to read out, companies are also looking for improved PK, safety and convenience.
Encoded antibodies are making little noise, rarely getting top billing in most companies with pipelines of DNA or RNA products. But the handful of companies pushing the technology are positioning their encoded mAb candidates as opportunities for proof of concept and growth.
If successful, the technology could disrupt the biologics business by avoiding the need to manufacture proteins in cell lines. It could also produce a step change in the ability to deliver products for developing-world diseases.
Most of these therapies deliver long-lasting, but not permanent, in vivo protein expression via mRNA transcripts or DNA plasmids. Those modalities have been more commonly deployed to develop vaccines or endogenous protein replacement therapies.
RNA-focused biotech CureVac AG is one of the early adopters. CEO Daniel Menichella said pharmas have been approaching his company to do experiments under material transfer agreements.
“One thing we often hear is, people have an antibody they think is really interesting, but they can’t get it to express to the levels they’re looking for, or it’s hard to manufacture,” he said. “People are also