Monthly Archives: June 2010

DOE for bioassays

Posted on June 30, 2010 by Dan

A little blurb about using Design of Experiments (DOE) for bioassay development: http://www.thefreelibrary.com/DOE+factors+into+bioassay+development,+says+USP+workshop-a0202645042

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DOE Book Chapter 1!

Posted on June 29, 2010 by Dan

Hello everyone, I haven’t been posting much on the blog lately.  That’s because I’ve been busy writing the first chapter in a book on using Design of Experiments (DOE) in assay development.  I have published the first chapter for free … Continue reading →

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Introduction to parallelism testing in potency assays

Posted on June 9, 2010 by Dan

In a previous blog post I stated that a potency value doesn’t mean anything unless the shape of the curves of the reference standard and the unknown are exactly the same:  This condition is known as parallelism (or more correctly … Continue reading →

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National Institutes of Health Chemical Genomics Center

Posted on June 9, 2010 by Dan

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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Online conferences

Posted on June 8, 2010 by Dan

I just spent some time looking at some of the talks at BioConference Live. I was originally registered to watch some of them live, but I had conflicts so I wasn’t able to.  I was actually surprised at the quality of the … Continue reading →

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Standardized use of DOE in immunoassay development and validation

Posted on June 2, 2010 by Dan

Design of Experiments (DOE) can be an extremely powerful way to quickly develop, optimize, and validate potency assays. This slide deck describes a standardized approach for developing immunoassays using design of experiments, with a case study for one assay: Joelsson ELISA … Continue reading →

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Automated DOE for Immunoassays

Posted on June 2, 2010 by Dan

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 … Continue reading →

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Bootstrap method for setting parallelism metric cutoff

Posted on June 2, 2010 by Dan

Assessing parallelism in potency assays is a topic that is currently hotly debated.  In most cases, this assessment is performed using some sort of metric that is calculated for each assay.  A cutoff is then established on this metric to … Continue reading →

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Paper on automation of a cell based assay

Posted on June 2, 2010 by Dan

We recently published an article on the automation of a cell based potency assay for a varicella vaccine.  Here’s the citation and abstract: Journal of Virological Methods Volume 166, Issues 1-2, Pages 1-110 (June 2010) Rapid automation of a cell-based … Continue reading →

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