Plus Therapeutics Inc (NASDAQ: PSTV) has met two significant milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome (186RNL).
The Company has entered into a master services agreement (MSA) with IsoTherapeutics Group LLC to develop, manufacture, and supply Rhenium-186 isotope for its 186RNL investigational radiotherapeutic.
The agreement will help ensure Rhenium-186 meets FDA requirements for use in late-stage clinical trials.
Under the MSA, IsoTherapeutics will develop a synthesis process and in-process manufacturing controls, test method development and validation, stability studies, and manufacture Rhenium-186.
Additionally, Plus Therapeutics completed the technology transfer of analytical test methods with Piramal Pharma Solutions (PPS) for 186RNL drug product intermediate.
As previously disclosed, Plus Therapeutics entered into an MSA with PPS in early 2021 to develop, manufacture, and supply Plus Therapeutics' 186RNL intermediate drug product.
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