Here’s another good reference from the NIH for developing different types of assays:  Assay Guidance Manual

It’s a good read if you have the time.

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This is a slide deck describing the implementation of a standardized, DOE-based immunoassay development process using laboratory automation: Joelsson – Rapid Assay Optimization DOE
This study was also published as an article:

J Immunol Methods. 2008 Aug 20;337(1):35-41. Epub 2008 Jun 12.
Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments.
Joelsson D, Moravec P, Troutman M, Pigeon J, DePhillips P.

Abstract:

Transferring manual ELISAs to automated platforms requires optimizing the assays for each particular robotic platform. These optimization experiments are often time consuming and difficult to perform using a traditional one-factor-at-a-time strategy. In this manuscript we describe the development of an automated process using statistical design of experiments (DOE) to quickly optimize immunoassays for precision and robustness on the Tecan EVO liquid handler. By using fractional factorials and a split-plot design, five incubation time variables and four reagent concentration variables can be optimized in a short period of time.

Thanks for reading!

Dan

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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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