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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

Click here for access to the webinar.

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

Ask an Extractables and Leachables expert!

Click to speak to our technical folks about your E/L needs today.