The biopharmaceutical industry is using these cells from Chinese hamsters as mini-drug factories. Scientists tweak the cells’ genes, multiply them inside shiny high-tech vessels called bioreactors and use them to pump out bespoke proteins that can attack disease. More than two-thirds of the proteins often used to treat cancer come from these hamster cells, says Anila Bhan, global manager for cell culture products at GE Healthcare Life Sciences in Boston.
The company is now upgrading its plants in Utah and Austria manufacturing cell culture media — the that supports their growth — to keep up with demand. Among other things, they will use Big Data in Utah to offer biomanufacturers real-time statistics and analysis on their “cell food.” Besides ramping up cell food production, the upgrade also includes a new manufacturing suite that will boost the Austrian plant’s annual production by tenfold.
The market for the cell-made proteins, called monoclonal antibodies, is worth tens of billions of dollars. They are a key part of a new class of drugs called biologics,the world’s fastest-growing class of medicines, which represent eight out of the top 10 therapeutics on the market today.
But manufacturing the nutrients for the cells — a kind of fine powder known as cell culture media — is a complex process. One step involves the milling of lots of different components, a process that is not too unlike using a blender at home. “When everything is done we have a nice powder that is uniform,” Bhan explains. “The technique sounds simple, but you have to really make sure that when you are manufacturing these 5,000- to 6,000-kilogram batches, a sample taken from the top of the batch is the same as one taken from the bottom.”
To say that this is a very sensitive process is an understatement. “A drop in alkalinity from pH 7.5 to 7 can ruin a batch,” says Margarita Hunter-Panzica, who manages strategy for cell culture products at GE Healthcare Life Sciences. “The cells have to stay healthy so they can talk to each other and produce the protein we want them to produce.”
Dangers lurk everywhere. Impurities in the cell culture media, which is typically dissolved in ultrapurified water, can reduce the quality and growth of cells and even be toxic to them, leading to hundreds of thousands or even millions of dollars in sunk costs. “We hear about it all the time,” Hunter-Panzica says. “Money and time is lost. Troubleshooting where the process failed is a cumbersome process.”
No wonder biopharmaceutical companies are clamoring for a reliable, high-quality food supply for their cell lines. It doesn’t help that some of the recipes blend more than 100 components like amino acids, lipids, vitamins, growth factors and salts. The cooking has to be done well, and quickly. “Everyone wants to have their drugs approved as fast as possible,” Hunter-Panzica says. “The most important part of the cell culture is to select the medium correctly, so biotechs can have the best outcome.”
So far, GE’s approach to cell food and protein production seems to be working. Fifteen out of 20 top biopharma companies are using cell culture media from GE Healthcare Life Sciences. “The burden of manufacturing at scale comes to us,” Bhan says. “And we do it well.”