Automated manufacturing and supply chain management systems will play a key role in running the highly time-sensitive production operations at its new U.S. radioligand therapy facility, says Novartis. “The facility in Indianapolis, IN, won FDA approval to make Pluvicto—a radioligand therapy (RLT) for prostate cancer—this month. The decision will facilitate “substantial supply increases for the foreseeable future,” according to Novartis.
Radioligand therapies, as the name suggests, combine a ligand that targets markers on the tumor with a radioisotope that emits therapeutic radiation to kill the cancerous cell to which it is bound. The ultimate aim of all RLT programs is to produce a highly selective cancer therapy that is less likely to damage healthy cells than an equivalent systemic treatment.
Time sensitive
Making RLTs at commercial scale is complex, notes a spokesperson, who points out that the sensitive nature of the radioisotopes involved presents developers with a significant logistical challenge.
“A challenge unique to manufacturing radiopharmaceuticals is how quickly we must produce RLTs,” she says. “It’s an intricate process requiring not just precision but also urgency—to ensure these medicines reach the patients who need them before the radioactive material in the medicine decays.”
For Pluvicto, the active substance is lutetium vipivotide tetraxetan which has a half-life of just under seven days. This means its production and distribution have to be as efficient as possible, adds adds Novartis official.
“Safe and efficient production, delivery, and administration before the treatment decays are critically important,” she continues. “The entire RLT manufacturing process operates on a timeline of just hours and days, starting with the short window we have at the facility to move from production through to shipping, so that patients receive their medicine at the specified date and time.”
Automation
To that end, supply chain management, manufacturing, and distribution operations at the Indianapolis facility have been automated, according to Novartis, who says implementation of the systems involved was informed by experience gained at other RLT plants.
“We’ve taken learnings from our first three sites—Millburn, NJ, Ivrea, Italy, and Zaragoza, Spain—and we are expanding numerous aspects of our capabilities to serve more patients starting with our facility in Indianapolis.”
Novartis’ investment in automated production technology also gives it the option to increase output.
“Our Indianapolis facility was purpose-built from the ground up to manufacture RLTs now and into the future. The facility includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry,” says the spokesperson. “Automated lines will optimize our production capacity and prepare for future increased demand for RLTs.”
And extra capacity may well be important for Novartis going forward. In addition to Pluvicto, the drug maker has another approved product—Lutathera for neuroendocrine tumors—as well as more than 15 clinical trials of RLTs underway.
In related news, Novartis has announced plans to expand manufacturing capabilities and build additional RLT supply facilities in Sasayama, Japan, and Haiyan, Zhejiang, China.
