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

Click here to register for the E and L webinar.

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.

Brush up on the key concepts of USP 665 by watching this on-demand webinar detailing USP 1665. 

Speak to a technical expert about your E and L needs today.