Live30: Monitoring protein impurities to ensure consistent C&GT products

7 January 2022
[Cell/Gene therapy] Are you prepared for FDA’s impurity concerns?

The guidelines state that you should characterize impurities and monitor process performance parameters for process consistency.

But what if no good impurity ELISA is available?

Join Ejvind Mørtz for an exploration of the 𝐥𝐢𝐦𝐢𝐭𝐚𝐭𝐢𝐨𝐧𝐬 𝐨𝐟 𝐭𝐫𝐚𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐦𝐞𝐭𝐡𝐨𝐝𝐬 (𝐞𝐠. 𝐄𝐋𝐈𝐒𝐀, 𝐒𝐃𝐒 𝐏𝐀𝐆𝐄, 𝐖𝐞𝐬𝐭𝐞𝐫𝐧 𝐛𝐥𝐨𝐭𝐭𝐢𝐧𝐠) for monitoring of individual protein impurities in cell & gene therapies, and the potential of mass spectrometry (LC-MS) to address this critical issue.

Find out more in this 30-minutes on-demand webinar: