The Source Of GMP-Source® – How Client Demand Drives Innovation

By John Ballantyne, Ph.D., Co-Founder and Chief Science Officer, Aldevron

At the turn of the century, viral manufacturers were facing major headwinds, and the sector was in a rut. Part of the problem was the inability to get enough clinical grade DNA, quickly enough, at the right price point for them to be able to progress through clinical trials.

In the early 2000s, my team was approached by one client in particular. Paraphrasing, he said, “You have to step your game up. Research grade DNA is not going to be usable to produce clinical virus and we as a sector cannot afford cGMP plasmids. We need you to come up with something else.”

There is an old saying in biologicals manufacturing that the product is the process. Typically you do a lot of engineering upfront to come up with one singular fixed process that produces the product. GMP-Source^®, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.