Manufacturing Brief
The company is establishing commercial production capabilities to fuel plans to launch autologous CAR T cell therapies in China.
Constructing the cGMP facility will increase availability of actinium-225, a nuclear material central to radiopharmaceutical programs at AstraZeneca, Bristol Myers Squibb, Eli Lilly and Novartis.
Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.
Industry groups have identified upfront costs as a barrier to streamlining U.S. drugmaking. The nonprofit API Innovation Center has a proposed answer for how to tilt finances in favor of investments in continuous manufacturing.
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
The company plans to divest a drug it has made for 40 years, citing increasing production costs and falling prices.
Part of AbbVie’s vow to invest $100 billion in the U.S. over the next decade, the two Illinois facilities will make active ingredients for next-generation neuroscience and obesity drugs when they start operations in 2029.
The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
As the field grows rapidly, companies are luring people from other nuclear industries and tapping the expanding educational talent pipeline, but are constrained by a steep learning curve and the value of real-world experience.
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