CASE
Urgent Troubleshooting
A small biotech struggled with product instability during manufacturing at a large CMO, which couldn’t establish a suitable buffer exchange for lyophilization. Bioneer quickly developed and implemented a TFF process, enabling successful stabilization, lyophilization, and fill-finish.
Our solution
Bioneer developed a tangential flow filtration (TFF) process to exchange the protein into a more suitable buffer for lyophilization, followed by lyophilization testing. Approximately 8 grams of protein were processed at Bioneer’s facilities, with the final filling and lyophilization also carried out in-house.
Key Results:
- Enabled successful lyophilization and long-term stability
- Rapid TFF process development and implementation
- Completed fill-finish of ~8 g protein for further use
