ScaleReady Announces a G-Rex® Grant has been awarded to Sonoma Biotherapeutics

Rhea-AI Summary

ScaleReady (TECH) announced a $300,000 G-Rex Grant awarded to Sonoma Biotherapeutics to accelerate development of a G-Rex based manufacturing process for gene-modified regulatory T cell (Treg) therapies for clinical investigation, targeting autoimmune disorders. The grant supports transition from open-flask methods to closed, scalable G-Rex devices and integration of ProPak GMP cytokines, process analytical technology, and novel closed-system tools from Wilson Wolf.

ScaleReady reports its G-Rex Grant Program has exceeded $40M in no-cost product commitments; individual awards are up to $300,000.

Positive

• $300,000 grant funds G-Rex Treg manufacturing process development
• Access to Wilson Wolf closed-system G-Rex devices and ProPak GMP cytokines
• ScaleReady program > $40M in no-cost product commitments

Negative

• None.

Insights

Cell therapy manufacturing expert

Small non-dilutive grant accelerates Sonoma Biotherapeutics' shift to a scalable G-Rex manufacturing platform.

Sonoma Biotherapeutics received a $300,000 G-Rex Grant on Nov. 3, 2025 to convert open flask processes into a G-Rex-based, modular, closed manufacturing workflow for gene-modified regulatory T cell (Treg) therapies. The award funds process development activities, access to ProPak™ GMP cytokines, and early trials of Wilson Wolf's integrated process analytic technology and new closed-system G-Rex models, which directly target CMC readiness for clinical studies.

The business mechanism is straightforward: non-dilutive product and technical support reduces near-term capital needs and shortens the technical risk path for scaling a cell therapy process. Key dependencies include successful transfer of the Treg process into G-Rex hardware, functional closure of the workflow, and demonstrated reproducibility under cGMP conditions. The grant size limits scope; this funding supports development work but likely does not cover full clinical manufacturing validation.

Watch for concrete deliverables over the next 6–18 months such as an operational closed G-Rex process, qualification data for ProPak™ reagents, and any described process analytic readouts. Those milestones will be the primary indicators that the grant materially advances SonomaBio's clinical CMC program.

ST. PAUL, Minn., Nov. 3, 2025 /PRNewswire/ -- 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 & Gene™. 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. 

For more information about the G-Rex^® Grant Program, please contact info@scaleready.com. 

For more information about LEAN Cell & Gene™, please use this link to register for the free event series. 

About ScaleReady

ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. 

The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. 

CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. 

For more information about the ScaleReady G-Rex^® Grant Program, please contact info@scaleready.com.

About Wilson Wolf Manufacturing 

Wilson Wolf (www.wilsonwolf.com) is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. 

Wilson Wolf's mission is to create hope for cancer patients, one G-Rex^® device at a time. 

About Bio-Techne Corporation 

Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex^® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at:, LinkedIn, X or YouTube. 

Contact: David Clair, Vice President, Investor Relations & Corporate Development 

david.clair@bio-techne.com

612-656-4416

About CellReady LLC 

CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. 

CellReady's mission is to create hope for cancer patients, one G-Rex^® process at a time. 

About Sonoma Biotherapeutics 

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring immune system balance. Founded by pioneers in Treg biology and cell therapy, including Dr. Fred Ramsdell—whose foundational research in Treg biology was recognized with a 2025 Nobel Prize—Sonoma Biotherapeutics combines deep scientific expertise with proprietary platform technologies to advance a new generation of targeted and durable Treg cell therapies.

In addition to its lead, proprietary Treg program, SBT-77-7101, Sonoma Biotherapeutics is collaborating with Regeneron to advance a pipeline of Treg cell therapies for autoimmune diseases. 

For more information, visit sonomabio.com and follow Sonoma Biotherapeutics on X (formerly Twitter) and LinkedIn.

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SOURCE Bio-Techne Corporation

FAQ

What did ScaleReady announce on November 3, 2025 regarding TECH and Sonoma Biotherapeutics?

ScaleReady awarded Sonoma Biotherapeutics a $300,000 G-Rex Grant to develop a G-Rex based manufacturing process for gene-modified Treg therapies.

How will the $300,000 G-Rex Grant affect Sonoma Biotherapeutics' manufacturing plans?

The grant funds transition from open-flask methods to closed, scalable G-Rex devices and integration of ProPak GMP cytokines and PAT tools.

What technologies from Wilson Wolf will Sonoma Biotherapeutics access under the G-Rex Grant?

Early access to novel closed-system tools, integrated process analytic technology (PAT), and new G-Rex models from Wilson Wolf.

How large is ScaleReady's G-Rex Grant Program commitment as of November 3, 2025?

ScaleReady reports the program has surpassed $40M in no-cost product commitments to grant recipients.

What is the maximum individual award size in ScaleReady's G-Rex Grant Program (TECH)?

Individual G-Rex Grant awards are worth up to $300,000.

Does the G-Rex Grant support clinical development of Sonoma Biotherapeutics' therapies?

Yes. The grant aims to enable expeditious development of manufacturing processes for Treg therapies intended for clinical investigation in autoimmune disorders.