Another nice reference I found:

http://www.google.com/url?sa=t&source=web&ct=res&cd=4&ved=0CBkQFjAD&url=http%3A%2F%2Fwww.nihs.go.jp%2Fdbcb%2FBiologics_forum%2FBioforum-4%2F4-DrPetricciani.pdf&rct=j&q=potencyassay.com&ei=GZf1So2THcfj8Qbvt5DzCQ&usg=AFQjCNGt72BARy6jI5WbcU03CUrUU-zf6w

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I ran across this PDF by Susan Kirchner at CDER.  It’s a nice overview of why we need run potency assays for biotherapeutics.

http://www.usp.org/pdf/EN/meetings/bioassayWorkshop/session1f.pdf

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