Building a USP1023 trace metal monitoring program for cell culture media

Trace metals in complex cell culture media (CCM) can have a significant impact on critical quality attributes of recombinant therapeutic proteins. Raw materials are perhaps the greatest sources of trace metals and are therefore the primary method manufacturers use to control trace metals in CCM. Historically, inductively coupled plasma mass spectrometry (ICP-MS) has been favored for trace metal analysis due to its high sensitivity, detection, and quantification capabilities. However, it can be challenging to develop suitable methods for raw materials and complex CCM products. USP<1023> has provided much needed guidance on this subject. We have developed in-house methods to test raw materials and complex CCM that meet and exceed requirements listed in USP<1023>. These test methods accurately and precisely detect metals in raw materials and complex CCM products and represent a cornerstone of our raw material characterization program.

Speaker
Nathan Israelsen