ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that Sonoma Biotherapeutics has been awarded a $300,000 G-Rex® Grant. SonomaBio’s G-Rex® Grant will enable expeditious 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 their grant, SonomaBio will explore innovative 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), novel closed system tools, and new G-Rex models.
ScaleReady’s G-Rex Grant Program has now surpassed $40M of no-cost product commitments to grant recipients with the goal of advancing the state of cell and gene-modified cell therapy (CGT) development and manufacturing. Individual Grant Awards are worth up to $300,000. G-Rex Grant Recipients also gain access to exclusive support from ScaleReady’s growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more.
Importantly, ScaleReady has just introduced yet another FREE program to accelerate the universal presence of highly efficient and scalable CGT manufacturing. Under this program ScaleReady has partnered with Hanson Wade to launch an event series called LEAN Cell & GeneTM. All CGT entities are invited to attend and learn how to systematically identify and eliminate waste, stabilize business operations, increase drug product quality and supply, and develop a LEAN approach to cell and gene therapy development and manufacturing.
