Oxford BioMedica PLC (OXBDF)

[marcusl2]

It's already difficult meeting demand for the inactivated viral vectors necessary for gene therapy research, but it's only going to become more difficult following the FDA's approval of Yescarta and Kymriah. The typical CAR-T clinical trial is only enrolling dozens of patients, but the addressable market for commercial-stage CAR-Ts totals in the thousands of people in the U.S. alone.

And therein lies a problem for drugmakers. To guarantee the quantities necessary for commercializing CAR-Ts, they need to either outbid one another to secure supply from third parties or build their own in-house production.

For example, Novartis locked in all the supply it needs for Kymriah back in 2014, but Novartis had to agree to pay Oxford BioMedica royalties on Kymriah's commercial sales to get the deal done.

At bluebird bio, management's nervous enough about viral vector supply that it's investing in a two-pronged approach. It's acquiring a 125,000 square foot manufacturing facility to make some of the viral vectors it needs. Additionally, it recently agreed to multi-year deals with three viral-vector manufacturing partners: Brammer Bio, Novasep, and MilliporeSigma, a division of Merck KGaA. These investments aren't going to be cheap, but they should be able to provide the viral vectors necessary for bb2121 (its multiple myeloma CAR-T), Lenti-D (its cerebral adrenoleukodystrophy gene therapy), and LentiGlobin (its beta-thalassemia and sickle cell disease gene therapy).

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