Biological Potency Assays Grow in the Importance

We've teamed up with BioQuality to bring you their Bioassay Special Edition of 2012. Articles covered include Biological Potency Assays Grow in the Importance: Assays have Both a Long History and a Critical Modern Role and BioAssay Conferences: Technical and Regulatory Info- All Agree that Mechanism of Action is the Key.

Here's an excerpt from Biological Potency Assays Grow in the Importance: Assays have Both a Long History and a Critical Modern Role:

Biological potency has long been considered a critical quality attribute, (CQA), in fact longer than the snappy CQA acronym. The first FDA regulated product, with a quantitative potency assay, surfaced in 1949. 

Dr. Margaret Pittman, director of the Biologic Control Laboratory (forerunner of CBER), developed a potency assay for the pertussis vaccine and correlated potency with human efficacy. It quickly became a standard release assay. 

The method was a lethal dose 50% (LD50) assay. The LD50 value was estimated without computers using a probit. The assay required 16 or 32 animals per testing group.
Compare to today, in which commercial software providers duke it out for market share, biological read-outs include animals, tissues, cultured cells, frozen ready-to-use cells and statisticians argue nuances of determining similarity between test and
reference samples. 

However, what has not changed since the 1940’s when Dr. Pittman was doing her ground-breaking work, is the singular lack of guidance on what the regulatory expectations are for the method. 

Since the late 1990’s, the potency assay has been touted as the critical quality assay to support comparability studies, development and release of biopharmaceuticals. Now with the advent of BioSimilar products, there is an even stronger emphasis on potency bioassays. 

The original pertus sis potency assay become both a release assay and a surrogate for human efficacy. This is now considered the holy grail of bioassay, but is not typically achieved outside of the vaccine industry. Even here, it is only commonly accepted for challenge animal potency assays. Newer, binding or neutralization vaccine potency assays still meet strong resistance if trying to claim the ability to predict efficacy.

Download the full article here.

This May in Seattle, IBC will host the 23rd International Biological Assay conference which will focus on these topics and more. For more information on the program, download the agenda.  If you'd like to join us in Seattle, as a reader of this blog when you register to join us and mention code Bio13JP, you'll save 20% off the standard rate!   

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