Gates Package — page 1023

nearly every aspect of the building, from the temperature of the air and the volume of airflow to the curvature of the wall corners. Another reason the industry is so challenging is the nature of the product. Vaccines are made up of massive molecules, on the order of a million times heavier than the molecules that make up aspirin. Many are created in living cells--flu vaccines, for instance, are typically grown in chicken eggs--and since living things are inherently unpredictable, you don't necessarily get exactly the same result each time. Yet getting almost exactly the same result each time is crucial to making a vaccine that's safe and effective. You need highly specialized equipment, and you need trained technicians to run it, and even then, there are half a dozen or more variables that could change the final product in subtle but important ways, every time you make a new batch. Once you've found a method for making a vaccine and developed one that's safe for humans, you have to reproduce this method every time you make it--that's the only way a regulator can confirm that you've gotten the same result you got previously. In contrast with checking a small molecule--where someone can examine it and say, "I don't particularly care how you made this thing; I can tell it has the right atoms in the right places"--checking a vaccine requires the regulator to watch how you make it and then, on an ongoing basis, make sure you don't change anything. By comparison, reproducing something like software is a cinch. Once you've debugged your code, you can copy it as many times as you want without fear that something new will suddenly go wrong with it. If making copies of software occasionally introduced new problems, the industry wouldn't have been nearly as successful. It also costs a lot of money to develop a vaccine: Estimates for the total cost to get one developed and licensed range from $200 million to $500 million. The number goes even higher