rBIO, Co. — Posts

Scaled bio-production processes from 2L to 20L under GLP-compliant conditions, developed additional production clones to ensure redundancy and process resilience, and conducted optimization of reaction conditions in collaboration with Shilpa Biologics. These efforts build on earlier work selecting commercial-grade expression vectors, scaling from 0.2L to 2L, validating expression systems, and developing purification and analytical methods towards the ultimate goal of commercial-level bio-production (1,000L scale).

rBIO has advanced its bio-production capabilities by selecting an optimized expression vector for commercial applications, successfully scaling fermentation processes from 0.2L to 2L, and evaluating and validating expression conditions. The team, in partnership with Aurigene Pharmaceutical Services, also developed purification and analytical methods and confirmed in-vitro biochemical activity of the expressed insulin.

Successful completion of lab-scale isolation of two additional key therapeutic proteins including erythropoietin and hemagglutinin, through a Shared Research Agreement with Washington University in St. Louis. This achievement further validates the strength and versatility of rBIO’s underlying synthetic biology platform and engineered cellular systems.

Successful completion of lab-scale isolation of three key therapeutic proteins including insulin, uricase, and alpha-1 antitrypsin, through a Shared Research Agreement with Washington University in St. Louis. This achievement validates the strength and versatility of rBIO’s underlying synthetic biology platform and engineered cellular systems.

In November 2024, rBIO successfully completed an animal study that demonstrated clear bioequivalence between R-biolin and Novo Nordisk’s, Novolin-R, confirming comparable pharmacokinetics and efficacy. These results mark a major milestone in R-biolin’s path toward commercialization, providing critical validation for regulatory approval and future clinical trials.