Biologics are a class of medicines produced in living organisms, which poses an interesting paradox. On one hand, we have the ability to tap into nature's toolbox to make highly sophisticated medicines. But on the other, we have to constantly deal with the awesome power of nature and its inherent variability.
It is this paradox that makes manufacturing biologic medicines such a fascinating, complex, and often underappreciated modern marvel of science. Advances in the manufacturing process now allow us to produce biologics at a scale that was, at one time, impossible to imagine.
It's Complicated
If making small molecule drugs is like building a bicycle, making a biologic drug is like building a jet1
Going the Distance
Given the complex challenges inherent to manufacturing, our work starts at the very beginning of a medicine's journey towards regulatory approval
Pre-Clinical Experiments
Clinical Trials
After FDA Approval
From Grams to Tons
Our ability to create high-quality biologics has increased exponentially over the last 30 years
1980s
2015
From DNA to IND
We've been able to cut down the time it takes to go from the genetic engineering stage (DNA) to filing for an Investigational New Drug (IND) application2
A Massive Scale
The biotechnology revolution that started at Genentech has changed the entire landscape of medicine
- http://www.slideshare.net/bathasu/the-chemistry-of-monoclonal-antibodies
- Data on file
- http://www.gene.com/medical-professionals/medicines