The production of biologicals is an important challenge for the industry. Today, very often, the only way to have a sterile final product is to, first, use sterile components and then, launch the production in a fully aseptic manufacturing facility. What if we could terminally sterilize the protein-based outcome once produced?
More and more biologicals are brought to the market, and the facts show it clearly. First, in 2014, there were more biologicals than small molecules approved by the FDA. Secondly, Sanofi generates already 50% of their sales form biologicals and have 80% of its pipeline full of them.
The production of biologicals is made inside GMO microorganisms or cells. This is how biotechnology was born in the 80s with Genentech producing the first insulin in bacteria. It then evolved to produce growth hormones, EPO by Amgen being one of them, or more recently monoclonal antibodies such as anti breast cancer Herceptin (trastuzumab) by Roche.
A big challenge in this production process is that the resulting product has to be sterile,