Biologics

Meet the New Medicines, page 3

Biologically produced drugs, like antibiotics, have transformed human society. Like small molecules, they bind to a target protein in the body and disrupt it. But they are huge: made of protein chains, they are hundreds of times bigger than small-molecule drugs.

A protein-based drug is not a single, unique molecule – it is a mixture of very similar molecules that have slight differences among them. Companies use microorganisms like bacteria and yeast, or even mammalian cells, as ‘biological factories’ to make these proteins.

Manufacturing biologics

Once the biologic drug is produced, it has to go through many different processes until it’s isolated, purified, and fit for human use. The entire process of making sure you have precisely the right combination of near-identical molecules is extremely complex.

That extra time, equipment, and scrutiny is absolutely essential. It’s what makes protein drugs so much more expensive to make than small molecules. In addition, for many biologics the fiendishly complicated manufacturing process hasn’t changed much in 30 years. Making changes would mean starting over with safety and efficacy testing, and going through a long approval process. However, recent discoveries have expanded our understanding of how microorganisms make proteins, making it possible to use mammalian cell systems to manufacture proteins 1000 times faster than in the 1980s.

But it is not enough. To make a these drugs cheaply, we need cost-saving breakthroughs in biotechnology.