Plus Therapeutics Builds Dual-Site GMP Redundancy for REYOBIQ Pivotal Push

Plus Therapeutics is expanding its GMP manufacturing footprint for REYOBIQ ahead of pivotal trials, activating a second contract manufacturing site through a Master Services Agreement with SpectronRx. The move signals how radiopharmaceutical sponsors are responding to supply chain fragility by building redundancy into late-stage clinical infrastructure before regulatory submissions demand it.

Under the MSA, SpectronRx's Indiana facility will assume technology transfer responsibilities covering the REYOBIQ manufacturing process, Rhenium-186 isotope processing, and associated analytical methods. Critically, the site consolidates isotope production and drug product manufacturing under one roof, reducing inter-site logistics dependencies that have historically complicated radiopharmaceutical supply chains. SpectronRx joins Radiomedix as a second GMP manufacturing site, while Rhenium-186 isotope supply is sourced through Telix Pharmaceuticals. Plus Therapeutics has cited a 2026 target milestone to complete manufacturing scale-up for REYOBIQ late-stage clinical supply.

REYOBIQ (rhenium Re186 obisbemeda) is an injectable radiotherapy under evaluation for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer across three clinical trials: ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC. The ReSPECT-GBM trial is supported by the National Cancer Institute, ReSPECT-LM by a three-year $17.6 million CPRIT grant, and ReSPECT-PBC by a $3 million U.S. Department of Defense Peer Reviewed Cancer Research Program grant. For QA and supply chain leads, the multi-sponsor funding structure adds a layer of external oversight that will shape batch release timelines and documentation requirements across sites.

For plant heads and regulatory affairs teams tracking radiopharmaceutical CMO strategy, the SpectronRx engagement illustrates a broader industry pattern: sponsors building multi-partner manufacturing networks early enough to validate processes and align regulatory packages before pivotal data readouts. Technology transfer at this stage, encompassing analytical methods and regulatory expertise alongside manufacturing procedures, positions both sites to support a future BLA or NDA submission without requalification delays. Source: Plus Therapeutics press release via GlobeNewswire, April 23, 2026.