The efficacy and safety of biopharmaceutical products, combined with their ability to address previously untreatable conditions is driving strong demand. Concurrently, to accelerate access to life-changing medicines, the number of breakthrough therapies and fast track designations are increasing, shortening drug development timelines considerably.
Compact timelines with no quality compromise
To help you accelerate your market readiness without compromising on quality or flexibility, we have created Ibex® Develop, an innovative CDMO service offering which aims to take you from process characterization to BLA submission in just 22 months.
As clinical and commercial production are located under the same roof, it simplifies comparability requirements and eliminates the need for tech transfers between sites. Additionally, you can commercialize from the same bioreactor that was used for production of your clinical material.
Flexible capacity to meet your clinical and commercial needs:
- Single-use process technology raises efficiency and enables quick adaptation to new processes, formats, and titers.
- Fully-modular operating suites addresses product demand unpredictability to flexibly reach your expansion requirements on site.
- Access to our global supply network with production scales up to 20,000 L.
- Drug product batch sizes from 5 to 500 L for clinical and launch supplies of liquid or lyophilized product.