Ensure Integrity of Your Single-Use Systems
Join us for a webinar on assurance of integrity of single-use systems
In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user’s deployment and use.
You will learn about:
- The industry trends and recommended approach for the assurance of integrity of single-use systems
- Available solutions for the highest level of assurance of integrity of SUS
- A new integrity test for Allegro 2D biocontainer assemblies
Hélène Pora, Ph.D.
Vice President Technical Communication & Regulatory Strategy
Global Product Manager for Single-Use Technologies
Learn more about the Helium Integrity Test.
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