Thursday, August 23, 2012

Biologics Manufacturing - Great Amgen Video

Here's a really informative video on biologics manufacturing.

Or if you prefer to watch this on YouTube, start at 15 seconds in and you can stop watching at 3:28 where the talking points begin.

It's the same old talking points that I've addressed:
My questions for innovator drug manufacturers are as follows:
  1. Is your Master Cell Bank single-cell sourced?
  2. You have never upgraded your cell line (v2.0) for an existing product, correct?
  3. Are you willing to publish the CofA testing requirements of your clinical material and abide a regulatory body approving/rejecting drugs according to whether or not each batch meets/fails those CofA specs?
Your YES response to all these questions will stand me corrected.

All the propaganda aside, nice video.

For more information on biologics manufacturing, see Amgen's biotech learning resource.

1 comment:

Anonymous said...

thanks for sharing this.. very useful to putting things in perspective..