Alnylam gave a first peek today inside its new biotherapeutics manufacturing business, launched in November. So far, it looks kind of intriguing. Though best known for as a leader in the race to turn siRNA into viable therapeutics, the company has embarked on a bit of a side project: using siRNA to improve the yield of biologics manufacturing process.
As you’ve probably read, therapeutic proteins such as monoclonal antibodies ain’t cheap. And though it’s safe to assume the mark-up on biologic drugs like Genentech’s Avastin is high, they also are quite expensive to produce. One major issue has been the low yield of those infamous Chinese hamster ovary cells churning out some of our antibody therapeutics—they don’t live long and not everyone in the pot likes to make drugs.
Alnylam is hoping to fix that yield problem. As Stuart Pollard, Alnylam’s vice president of scientific and business strategy explained in a chat today, the goal is to move beyond the crude modifications to temperature, pH, and nutrient content that companies make to improve biologics manufacturing yields. Alnylam’s idea was that siRNAs could be used to silence some of the proteins that contribute to cell death.
Today’s data is an early look at how effective siRNA might be at improving yields. The company looked at two metabolic pathways that impact the viability of cells, and, though it was done at a small scale, did show that its siRNA was able to nearly double the number of cells that were active. “We see almost doubling of the viable integral cell tanks over that period of 15 days where we’re applying siRNAs,” Pollard said.
Yes, you might say, but many others are looking at how to improve yield through new technologies. Merck didn’t pay $400 million for GlycoFi in 2006 for nothing: the biotech’s engineered yeast that can make consistent, complex proteins laid the groundwork for Merck’s biosimilars strategy. So why would using siRNA in manufacturing be an interesting proposition? Aside from improving yield, siRNA could be simply added to existing master cell lines. In other words, this is a process improvement that could be applied to drugs already on the market, those in development, and anything on the horizon.
Still, these results were only at the one-liter scale, and Alnylam has yet to come out with data showing it has successful made a protein out of the process. Pollard says scale-up is underway, and more data will be forthcoming. But Pollard seems confident of its potential: “When will this application be used commercially? We think it could be pretty near term.”
Any route that can make manufacturing of biotherapeutics more affordable will surely be in demand, particularly as big pharma pushes into making generic biologics (or, if you prefer, “biosimilars”). Just today, the WSJ reported that Pfizer had revealed its first three biologics that aim to outdo existing drugs, two improving upon Genentech/Biogen Idec’s Rituxan and another improving the potency of Amgen’s Embrel.
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