Novartis Breaks Ground on Denton RLT Site, Completing Construction Start Across All Five US Facilities

Radioligand therapy's manufacturing constraints are tightening as patient demand expands, and Novartis has moved to address that pressure directly: the company broke ground on a 46,000 sq. ft. RLT manufacturing facility in Denton, Texas, its fifth US site and first in the state, with operations targeted for 2028.

The Denton facility joins existing RLT sites in New Jersey, Indiana, and California, with a fifth site under development in Florida, completing a coast-to-coast network. For plant heads and supply chain leads, the strategic logic is explicit: each RLT dose is custom-manufactured and time-sensitive, making geographic proximity to treatment centers a direct variable in on-schedule dose delivery. Novartis reports a greater than 99% on-planned-day administration rate across its current network, a benchmark the Denton site is expected to sustain and extend to southern US patient populations.

Staffing requirements at the new site will span bioengineering, advanced manufacturing, quality, and operations. QA directors evaluating the build-out should note that RLT manufacturing carries distinct radiopharmaceutical handling requirements, sterility assurance protocols, and chain-of-custody controls that differ materially from conventional sterile fill-finish environments. Regulatory affairs leads will be tracking how the facility's design and validation program aligns with 21 CFR Part 211 and applicable NRC licensing obligations as construction progresses toward the 2028 operational target.

The Denton groundbreaking is part of Novartis' $23 billion, five-year US investment commitment announced in April 2025, which encompasses seven new and three expanded facilities currently under construction. Recent milestones include an April 2026 announcement of an active pharmaceutical ingredient facility in Morrisville, North Carolina, targeting solid dosage, capsule, and RNA therapeutic manufacturing across oncology, immunology, and cardiovascular indications. The breadth of the build-out signals a supply resilience strategy oriented around domestic manufacturing of key medicines for US patients rather than import-dependent sourcing.

US Under Secretary of Commerce Jeffrey Kessler and Texas State Senator Brent Hagenbuch attended the groundbreaking alongside Novartis leadership, reflecting the regulatory and economic policy dimensions of the investment at both federal and state levels.

The 2028 operational target sets a concrete process validation and commissioning timeline that quality and regulatory teams at Novartis and its contract partners will need to plan against from the current construction phase forward.

Source: Novartis via GlobeNewswire, 7 May 2026.