Pathways To Success: Expert Insights on Single-Use Technology
- 60 min
The use of single-use technology (SUT) in bioprocessing is expected to increase at a compound annual growth rate (CAGR) of 16.0% from 2021 to 2028*.
This means the market demand for gamma irradiation, the current primary method for the sterilization in SUT, will soon significantly exceed supply, creating an urgent need for alternatives.
Watch industry expert Christelle Marcoux from GSK Vaccines (BioPhorum workstream member on alternatives to gamma sterilization) and James Hathcock, PhD from Pall Corporation (Bio-Process Systems Alliance X-Ray Committee Co-Chair) as they discuss the introduction of X-ray sterilization technology. They explain how bioprocessing companies, suppliers, and regulators need to work together to explore the opportunities for process improvements, as well as present a unified approach to the validation work required to gain regulatory approval.
By attending the session, you will learn more about:
- Why this is a critical change for industry and the responsibilities of each stakeholder
- Key questions to address for biomanufacturers
- How gamma and X-ray irradiation compare
- What testing has been completed and key milestones for readiness for industry
- An example of how to qualify a SUS sterilized with X-ray irradiation
Speaker and Moderator
James Hathcock (PhD)
Sr Director, Regulatory and Validation Strategy,
James Hathcock’s role includes responsibility for the characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He currently leads the BPSA initiative on X-ray qualification for single-use disposables, the BioPhorum Community of Practice for Extractables and Leachables, and the ASME-BPE task group on single-use biocontainers. He has previously served as an expert panel member for USP <665> & <1665> and is an active member of ASTM, ASME-BPE, PDA, ISPE, BPSA.
Senior Manager - Quality for Suppliers and Incoming Materials, GSK Vaccines
Christelle Marcoux from GSK Vaccines is a Bioengineer specialized in brewing and pharmaceutical industries. She made her career in the single-use systems spending 20 years on commercial support and services, development, validation and implementation strategy for several companies like Merck and GSK Vaccines. In January 2015, she joined GSK Vaccines, where she worked as Head of Single-Use System Technologies in Global MSAT IM before moving to the Quality for Suppliers and Incoming Materials Department as Senior Manager in November 2021.
*source: Single-use Bioprocessing Market Size, Share & Trends Analysis Report By Product (Probes & Sensors, Simple & Peripheral Elements), By Workflow (Downstream, Upstream), By End-use, By Region, And Segment Forecasts, 2021 - 2028
Register & Watch Now!
*indicates a required field