Friday, May 3, 2019

Regulating mAb analytics

In this nice review, the author covers the current state of mAb analytics, and how the current regulatory state affects their implementation

There is a nice summary of the current status in the market, as well as how we got here.

Owing to the increasingly complex nature of biologics the author differentiates between analytics for discovery, and process development.  And all of this in the framework of regulatory expectations.

This isn't groundbreaking, and if you are an analytics master, you might not learn a ton.  But if you are a process person like me, this is a nice summary of the state of the art as of today.

Is there anything in the world of analytics that you think is the future?  Recently the FDA published an article about bringing mass spec onto a validated GMP pathway.

Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics:

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