Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product

Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product Amylyx Pharmaceuticals partnered with Thermo Fisher Scientific to advance AMX-0035, its leading candidate to fight ALS, from development to a commercializable product. As it approached the pivotal milestone of Phase III studies, there were development and manufacturing factors that Amylyx and Thermo Fisher had to consider for process development and scale-up of registration batches.

Read this case study to learn how Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of the AMX-0035 campaign.

Authors:

  • Sanjay Konagurthu, Senior Director, Science and Innovation
  • David Ma, Technical Project Leader II
  • Shawn McConnell, Manager, Pharmaceutics and Process Technology
  • Joshua Cohen, CEO, Amylyx Pharmaceuticals
  • Tom Holmes, Global Head of Supply Chain, Amylyx Pharmaceuticals
  • Justin Klee, Co-CEO and Co-Founder, Amylyx Pharmaceuticals

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