Gates Package — page 1008

So let's return to our hypothetical example of a new pathogen. We've now developed a treatment, run trials to prove that it's safe and effective, and gotten the green light to make and sell it. It's time to start manufacturing. Although making a small-molecule drug is easier than making an antibody, which in turn is generally easier than making a vaccine for reasons I'll explain in the next chapter, it's still worth taking a moment to walk through the challenge of scaling up manufacturing. First, a team of chemists will work on finding the most effective way to produce the key part of our drug--known as the active pharmaceutical ingredient--by setting off a series of reactions using chemicals and enzymes. The best path might involve four or five separate steps: Our chemistry team will start with certain ingredients, spark a reaction among them, capture the by-products, use some of those in another reaction, and so on, until they have the active ingredient we're after. Then they'll turn it into the form in which patients will take it--such as a pill, nasal spray, or injection. Quality control is relatively easy for small-molecule medications, as opposed to vaccines. Because the product is just a string of molecules, and not a living thing, we can use analytical tools to confirm that it has all the necessary atoms in all the right places. It's hard to overstate the importance of this one fact. It is a godsend for everyone who cares about equity in global health, because it gave rise to one of the most important global health innovations in the past several decades: generic drug manufacturers committed to creating low-cost versions of lifesaving drugs. Historically, the companies that invent new drugs have been based in higher-income countries. Because it costs so much to develop a new product, they try to recoup their costs as quickly as possible by selling doses at the higher prices that rich countries can afford. It doesn't