Vybion - Protein Innovations

Autoimmune Drug

Client Objective

Vybion’s client needed to achieve rapid and cost-effective scale-up, subsequent production, and quality control of this proprietary recombinant protein. There was no process in place, and only benchtop methods were available.

The Results

Vybion optimized the fermentation in E. coli, improving yield by more than 100 times, from 20 mg/L to 2.5 grams/L.

We developed and optimized isolation of inclusion bodies, downstream processing, purification, and refolding of the protein.

Vybion manufactured preclinical material for toxicology, formulation and stability studies along with API and final formulation release validated methods.

Full production documentation and methods were transferred to a GMP production site.

Vybion continues process development for clinical production of this protein, and Vybion is working on other products for this client.