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.
With the publication of the new chapters in USP <665> due in September join Ken Wong from Sanofi Pasteur, Desmond Hunt from United States Pharmacopeia and James Hathcock from Pall Biotech to get the latest updates.
Participants will learn:
- About the USP <665> standardized extraction solution protocol for manufacturing components and systems
- What is new and what has changed in USP <665> and <1665> (as of September 2020)
- The top issues influencing the alignment of the BioPhorum extractables protocol and USP <665>
- What level of data end-users can expect to see
- How to apply USP <665> data sets to support risk assessment and qualification of single-use systems
- The opportunities ahead for simplifying the adoption of single-use technologies
Don’t miss this free BioPharma Asia webinar to hear from subject matter experts serving on the USP and BPOG panels!