ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corp. and CellReady, have awarded Sonoma Biotherapeutics a $300,000 G-Rex Grant.  SonomaBio’s G-Rex Grant aims to enable expedited development of a G-Rex based manufacturing process to produce gene-modified regulatory T cell (Treg) therapies for clinical investigation of SonomaBio products in development for various autoimmune related disorders. 

“Regulatory T cells represent a promising new treatment modality, and we are honored to support Sonoma Biotherapeutics’ trailblazing mission to bring these innovative therapies to patients suffering from debilitating autoimmune diseases. The G-Rex Grant is helping SonomaBio transition from open flask-based technology to the proven, commercially viable G-Rex platform—an essential step in preparing their CMC for commercial readiness,” said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. 

As part of the grant, SonomaBio will explore optimization strategies for their Treg platform process to establish a modular and scalable manufacturing approach using G-Rex. Functionally closing the manufacturing process will be accomplished through the integration of closed system G-Rex devices and, ProPak GMP Cytokines. Moreover, through the G-Rex Grant, SonomaBio will get early access to a variety of innovations coming from Wilson Wolf including integrated process analytic technology (PAT), new closed system tools, and new G-Rex models. 

ScaleReady’s G-Rex Grant Program aims to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing. G-Rex Grant Recipients also gain access to support from ScaleReady’s growing consortium of G-Rex Grant Partners who bring tools, technologies and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more.