Case
Full Development of Complex Protein
A small biotech company faced significant challenges expressing and purifying a complex protein, which was only producible as inclusion bodies (IBs) in E. coli. With limited data on the protein’s mechanism or mode of action, they required an experienced partner to drive development from early expression through to clinical manufacturing readiness.
Our solution
Bioneer conducted expression testing in E. coli and carried out strain development, followed by the creation of a tailored IB refolding process. Bioneer advanced the project through lab-scale and upscaled downstream development, implementing fed-batch fermentation and TFF. Bioneer performed in-vitro modelling to evaluate potency and mechanism of action, produced 50 L batches for preclinical toxicology studies, and transferred the final process to a CMO for clinical manufacturing.
Key Results:
- Achieved expression and purification of challenging protein
- Produced 50 L tox batches for preclinical studies
- Delivered process ready for clinical manufacturing at CMO
