Alignment to Standardized Extractables Testing, Facilitating Single-Use Adoption
A primary concern limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments. Experimental findings and insights from execution of both the BPOG and USP <665> extractables protocols on multiple single-use components will be shared, including similarities and differences in extraction profiles. Case studies will also be presented illustrating how Pall’s growing portfolio of BPOG extractables datasets can be used to help support component qualification and overall toxicological risk assessment for single-use systems.
Hélène Pora, Ph.D.
Vice President, Single Use Technology
James Hathcock, Ph.D.
Senior Director, Regulatory and Validation ConsultingTeam
White paper: A risk based approach to validation studies for sterilizing filtration.
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