#United States #Bio-Techne #G-Rex Grant #St. Paul #Sonoma Biotherapeutics

Groundbreaking G-Rex Grant Awarded to Sonoma Biotherapeutics

In a significant move for the biotechnology sector, ScaleReady has announced that Sonoma Biotherapeutics has been awarded a substantial G-Rex® Grant worth $300,000. This initiative, conducted in conjunction with partners including Wilson Wolf Manufacturing, Bio-Techne Corporation, and CellReady, is aimed at accelerating the development of gene-modified regulatory T cell (Treg) therapies for various autoimmune disorders. This grant underscores both the urgency and potential of innovative treatments in tackling autoimmune diseases.

Innovations in Treg Therapy Development

Sonoma Biotherapeutics specializes in engineered Treg therapies, which restore the immune system’s balance, making these treatments pivotal for patients suffering from severe autoimmune and inflammatory diseases. The awarded funds from the G-Rex Grant will primarily focus on enhancing a manufacturing process based on the G-Rex platform, making it commercially viable and efficient.

John Wilson, the CEO of Wilson Wolf and one of the co-inventors of the G-Rex technology, expressed his enthusiasm for the partnership, stating: “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.” He further explained that the grant would facilitate a crucial transition from open flask-based technology to a more advanced and reliable G-Rex platform.

Modular and Scalable Manufacturing Approach

The collaborative effort will allow Sonoma Biotherapeutics to innovate and optimize their Treg platform process. This process aims to establish a modular and scalable manufacturing approach utilizing the capabilities of G-Rex and ProPak™ GMP Cytokines.

One of the essential goals is to functionally integrate closed system G-Rex devices, streamlining the manufacturing operations. The grant will also provide early access to Wilson Wolf’s latest innovations, including integrated process analytic technology (PAT) and novel closed system tools. These enhancements are designed to improve efficiency and quality in the manufacturing process of Treg therapies.

Impact of ScaleReady’s G-Rex Grant Program

The G-Rex Grant Program, introduced by ScaleReady, has made significant progress since its inception, surpassing over $40 million in no-cost product commitments to grant recipients. Each individual grant, worth up to $300,000, aims to support the development and manufacturing of cell and gene-modified therapies (CGT). Recipients of the G-Rex Grant will also benefit from joining a consortium of G-Rex Grant Partners, all of whom bring a wealth of expertise in areas such as cGMP manufacturing and regulatory affairs.

As part of this initiative, ScaleReady has launched another complimentary program aimed at enhancing the presence of scalable CGT manufacturing techniques. This program is in collaboration with Hanson Wade and includes a series of events named LEAN Cell Gene™, designed to assist CGT entities in minimizing inefficiencies, stabilizing their operations, and maintaining high-quality standards in drug production.

About ScaleReady and Its Partners

Founded on the principles of innovation in CGT drug product development, ScaleReady leverages the G-Rex manufacturing platform that accommodates over 800 organizations. Used for roughly 50% of CGT clinical trials, the G-Rex is becoming essential in the industry's landscape. Moreover, Wilson Wolf Manufacturing focuses on redefining CGT therapy research with its G-Rex technology, striving to create life-saving solutions for cancer patients. Bio-Techne Corporation complements this ecosystem by providing specialized tools and bioactive reagents aimed at enhancing research and diagnostic capabilities.

Sonoma Biotherapeutics, supported by this grant, aims to develop cutting-edge Treg therapies that hold promise for patients with autoimmune conditions. With a foundation built on pioneering research led by esteemed scientists, the collaboration positions Sonoma at the forefront of therapeutic innovations.

As the biotech industry moves forward, collaborative efforts like those seen in the G-Rex Grant increasingly play a crucial role in fostering the rapid development of life-changing therapies for patient populations in need.

For further information about the G-Rex Grant Program or the LEAN Cell Gene™ events, interested parties are encouraged to visit the respective websites or contact the relevant organizations directly.