Monthly Archives: November 2009

Trending potency assays and bioassays with process control charts

Posted on November 22, 2009 by Dan

One of the most useful pieces of advice I ever got about potency assay development was to think of the assay as a process.  Once I started thinking of an assay as a series of steps with information and material … Continue reading →

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Detecting edge effects

Posted on November 9, 2009 by Dan

In a previous post on this topic, I discussed ways of preventing edge effects in plate-based potency assays. But how do you know you have them in the first place?   Sometimes it can take a long time and many runs … Continue reading →

Posted in Edge effects | 2 Comments

CROs for Bioassays

Posted on November 8, 2009 by Dan

I haven’t seen a comprehensive list of contract providers for bioassays anywhere so I decided to create my own.  This is a list I will be keeping of companies that do outsourced potency assays for GMP release (as listed on … Continue reading →

Posted in Outsourcing | 3 Comments

Potency Assays for Cell-based Therapeutic Cancer Vaccines

Posted on November 7, 2009 by Dan

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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Regulatory perspective on potency assays

Posted on November 7, 2009 by Dan

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

Posted in References, Regulatory issues | 2 Comments

Edge effects

Posted on November 7, 2009 by Dan

If you work in the potency assay field long enough you will eventually run into problems with edge effects.  Sometimes they are blatantly obvious, and in some assays you might not notice them at first, but over time they show … Continue reading →

Posted in Edge effects | 3 Comments

Welcome!

Posted on November 6, 2009 by Dan

Welcome to Potencyassay.com I’ve been working in the analytical development field at a major pharmaceutical company for the last ten years or so.  Most of that time, I’ve been involved with development of various kinds of potency assays.  I have … Continue reading →

Posted in Welcome! | 3 Comments