A day after The New York Times spotlighted the manufacturing and supply problems besetting a booming gene therapy field, with key players scrambling to maintain a stock of the benign viruses needed to make their products, bluebird bio $BLUE has come up with what it sees as a definitive solution to the problem.
The late-stage biotech has snagged a partially complete manufacturing complex in Durham, NC to do its own in-house manufacturing work while executing a series of contracts with suppliers. And bluebird execs say the basket of deals places them in control of their own destiny — at least as far as manufacturing is concerned.
The cost of the facility is relatively small, says bluebird CFO Jeff Walsh, coming in at $11.5 million. (Walsh isn’t saying who they bought it from, just that the original owners weren’t able to finish it.) But the longterm commitment, which includes hiring 50 staffers for the new internal operation while inking deals with outside operators, is anything but small.
“Solving manufacturing is a critical step,” says bluebird manufacturing and tech chief Derek Adams. “We’ve been working quite extensively over the last year or more to come up and execute on a longterm an strategy.”
The result involves a network of suppliers around the world, starting with Lonza and apceth Biopharma to make Lenti-D and LentiGlobin and three more contract operations: Brammer Bio (Cambridge, MA), Novasep (Gosselies, Belgium) and SAFC (Carlsbad, CA) for lentiviral vector across the pipeline.
As the CAR-T pioneers know only too well, working with patient cells in creating a personalized therapy is no easy task. In gene therapy you have to extract the cells, include a viral vector and corrective gene and get it back into the veins of patients in a matter of weeks. Any interruption along that process — or loss of quality — can be fatal for a gene therapy company like bluebird. And manufacturing issues in general remain one of the most significant threats to any biotech looking to take breakthrough products into the market, as the FDA has highlighted time and again in recent years.
Given the stakes, and the complexity, I asked Adams what keeps him up at night.
“The thing that keeps me up at night,” says Adams, “is that the overall supply chain for gene therapy products is so complex” it can be hard to make sure all the pieces are under control.
“I suspect that Derek is sleeping a little better now that we closed the deal,” says Walsh.
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