For single use components, conducting an Extractables and Leachables (E and L) study to quantify all known chemicals combined with a toxicological risk assessment are established approaches for ensuring patient safety and monitoring product yields.
However not all E and L studies are created equally, which has caused confusion among the biopharmaceutical industry.
Watch an on-demand webinar that explains the following:
- Explanation of USP, BPOG, and BPSA E and L protocols
- Our prediction for when USP 665 will actually take effect
- Using the right analytical technique to achieve the most comprehensive E and L profile
- Designing an E and 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
Not able to make the live E & L webinar?
No worries, we have you covered. Leave us a comment on the registration form to receive access to the on-demand version.