“Biotech is about accepting that the unit of production is the living cell,” said Robert Bradway, president of biotech Amgen, to a room of manufacturing business leaders on the MIT campus today. 

The biological therapeutics sold by Amgen and other companies are produced by bacteria or cultured mammalian cells. Even though researchers and companies have been manufacturing drugs in this manner for decades, there is still a lot to be learned about the biology of a cell, Bradway said. “We are still at a very early stage of understanding what happens in cells,” he said. “We need to understand the parameters of production to be able to get more of what we want and less of what we don’t.”

What biotechs like Amgen want more of is their therapeutic product. What they want less of are contaminants, whether they be undesired metabolic byproducts or viral contamination. Bradway pointed to recent drug shortages as an illustration of the challenge of production inside cells. Some 20 percent of the time, therapeutic production lines fail due to substandard product quality, said Bradway. After production quality, the second reason for shortages is production capacity, he said. Amgen itself has not been part of the drug shortage problem, but the company needs to boost its capacity. Amgen is planning “expanding its commercial footprint” from about 50 countries now to about 75 by 2015, said Bradway.

The industry is “ripe for change,” he said. “The idea that you can separate technology and innovation from manufacturing just won’t change where we are going.”