What does it take to get a new biotech drug to market? The process development starts with culturing cells and requires the right technology to reliably and efficiently produce them. The capability to seamlessly move out of process development, into clinical trials, and from small to large-scale cGMP manufacturing, is essential.
Bioreactors have long been a critical part of the cell culture process, and presented challenges when it comes to moving from PD to cGMP manufacture. The first single-use bioreactors were introduced around 25 years ago. Since then, the evolution of single-use technology has brought many benefits, such as closed gamma irradiated biocontainers and scalable systems. As a result, single-use bioreactors are increasingly used for small-scale, mid-scale and large-scale production runs.
In this webinar, we will present case studies illustrating the benefits of leveraging industry experts, proven methods, and integrated upstream solutions to design a robust, scalable and reproducible process.
Participants will learn:
- Strategies for transferring scalable processes from pre-clinical to cGMP commercial manufacturing
- How partnering with Pall’s Accelerator℠ process development services team will help reduce time to market
- Innovative single-use bioreactors whether you are growing adherent or suspension cells