Understanding Manufacturing
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
We help select and analyze cell lines with Genentech Research and Early Development
Clinical Trials
We supply the right amount of investigational medicine for each phase
After FDA Approval
We monitor the evolving demand around the world and scale accordingly to ensure consistent supply
From Grams to Tons
Our ability to create high-quality biologics has increased exponentially over the last 30 years
1980s
In the 1980s, the industry struggled to produce even grams of antibody per year
2015
We now produce 10 metric tons of biologics annually2
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
Genentech/Roche currently makes 15 different biologics across a diverse range of molecular formats3
By 2018, we will represent 25% of the world wide biologics manufacturing capacity2
We deliver medicines to more than 160 countries around the world2
References
- http://www.slideshare.net/bathasu/the-chemistry-of-monoclonal-antibodies
- Data on file
- http://www.gene.com/medical-professionals/medicines