USP 665, BPOG, Extractables and Leachables, SUS, and Risk Assessment; a webinar that provides clarity.
For single use components, conducting an Extractables and Leachables (E/L) study to quantify all known chemicals combined with a toxicological risk assessment are established approaches for ensuring patient safety and monitoring product yields.
With USP 665 on the horizon, groups like BPOG, and BPSA are taking a proactive approach to developing best practices for E/L studies for SUS. However not all E/L studies are created equally, which has caused confusion among the biopharmaceutical industry as to which approach to follow.
Click below to access a free webinar that provides an update on the following E/L topics:
- Explanation of USP, BPOG, and BPSA E/L protocols
- Our prediction for when USP 665 will actually take effect
- Using the right analytical technique to achieve the most comprehensive E/L profile
- Designing an E/L study based on your preference, including modified approaches
- Impact of unidentified chemical compounds – hint it will cost you $$$ in additional testing and product delays
- Risk Assessment navigation