The New Era of Automated Fill and Finish Systems
The fill and finish stage of drug development in cell and gene therapies is complex with various logistical issues that make it not only prone to contaminants but also make the process difficult to repeat consistently.
With manual drug product (DP) formulation and fill-finish currently the most common method used, these issues, in addition to being a time-consuming and imprecise process, can impede development and limit the size of batches produced. This in turn inhibits the DP from being scaled for larger patient populations.
An automated fill-finish system can address these risks by:
- Decreasing manual, error-prone process steps
- Maintaining cell temperature control
- Improving process control
- Allowing for precise formulation and filing
- Decreasing overall process time
- Enhancing cell viability and DP efficacy
- Enabling large batch production
Developed by Xiogenix, our study of the ARES ™ X20 Fill and Finish system is detailed in this whitepaper, which is available for download. The ARES X20 is an automated solution that allows developers and CDMOs to meet the industry’s demands and scale the formulation and fill/finish process.
This study demonstrates the shift in cell therapy drug development from manual systems that are less reliable to an automated system that reliably produces larger batches of high-quality DP, allowing for more life-saving therapies to reach market.
Read the whitepaper to learn more about the future of formulation and fill-finish.