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ScaleReady Announces $20 Million G-Rex® Grant Program for the Advancement of Cell and Gene Therapy (CGT) Development and Manufacturing

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ScaleReady, in cooperation with Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH), and CellReady, has unveiled a $20 million G-Rex® Grant Program aimed at advancing cell and gene therapy (CGT) development. The initiative offers up to $300,000 in G-Rex® devices, reagents, equipment, and support services to qualifying academic and commercial institutions. The program intends to reduce barriers to CGT innovation, enabling faster and more cost-effective development. Industry leaders emphasize the program's potential to enhance research timelines, streamline transitions to GMP manufacturing, and improve data quality for IND applications.

Positive
  • Initiative worth $20 million aims to advance cell and gene therapy (CGT) development.
  • Eligible applicants can receive up to $300,000 in G-Rex® devices, reagents, equipment, and services.
  • G-Rex® platform used in nearly 50% of CGT clinical trials and four approved T-cell therapies.
  • Program designed to expedite clinical data generation and development timelines.
  • Collaboration between ScaleReady, Wilson Wolf Manufacturing, Bio-Techne , and CellReady.
  • Potential to reduce costs and increase yield and potency in cell therapy manufacturing.
Negative
  • Dependence on grant approval process may delay access to resources.
  • to institutions that can provide compelling overviews and demonstrate program management success.
  • Potential risk of oversubscription, leading to grant distribution per applicant.

The announcement of ScaleReady's $20 million G-Rex® Grant Program offers substantial support for cell and gene therapy (CGT) development. This initiative will likely stimulate innovation and accelerate the commercialization of CGT products. By providing up to $300,000 in G-Rex® devices and associated services, the program effectively lowers the financial barriers for smaller biotech firms and academic institutions. This could potentially result in a higher number of IND (Investigational New Drug) applications, leading to an increase in the development pipeline for CGT products.

Another key point is the program's emphasis on reducing development timelines. G-Rex®'s integrated platform ensures consistent critical process parameters (CPPs) and critical quality attributes (CQAs), which are vital for a smoother transition from research to GMP (Good Manufacturing Practices) manufacturing. This continuity can significantly cut down on troubleshooting time, facilitating quicker movement through clinical trials and potentially leading to earlier market entry.

Overall, this program is strategically poised to benefit participants both in terms of time and cost, enhancing the efficiency of their CGT development processes.

From a financial perspective, this initiative by ScaleReady and its partners could have positive implications for the involved companies. For Bio-Techne Corporation (NASDAQ: TECH), the collaboration aligns with its mission to support groundbreaking therapies, potentially enhancing its reputation as a key player in the biotech sector. This program might also attract more customers to its suite of products and services, driving revenue growth.

Moreover, the grant program emphasizes cost-effectiveness and manufacturability, which are critical factors in the CGT space. By helping institutions optimize their processes and save both money and time, the program could indirectly bolster Bio-Techne's financial performance through increased adoption of its solutions. Additionally, the focus on minimizing development complexity and enhancing scalability could result in a more significant number of successful CGT therapies reaching the market, providing a longer-term revenue stream.

For investors, this program could signal a lucrative opportunity, as successful CGT products can translate to substantial financial returns.

The G-Rex® Grant Program is a robust effort to expedite cell and gene therapy advancements. The program promises to offer academic and commercial institutions access to critical resources, which is especially valuable in a field where time and money are often limiting factors. By ensuring that critical process parameters and quality attributes are maintained from research to GMP manufacturing, the program can help in reducing both the timelines and costs associated with clinical trials.

An important aspect is the program's potential to improve treatment efficacy and potency. By leveraging G-Rex®'s established platform, which is already used in multiple CGT clinical trials and approved therapies, the grantees can expect higher yields and more potent products. This can enhance the overall success rates of their programs, potentially bringing innovative treatments to market faster and benefitting patient access.

In summary, the G-Rex® Grant Program is likely to have a meaningful impact on the CGT field by accelerating research and development, improving manufacturing processes and ultimately aiding in the delivery of life-saving therapies to patients.

ST. PAUL, Minn., May 29, 2024 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady, today announced the launch of the G-Rex® Grant Program, a $20 million initiative to propel the advancement of cell and gene therapies (CGT).

The G-Rex® Grant Program will provide academic and commercial institutions engaged in IND enabling pre-clinical research, process development, and/or ongoing GMP manufacturing of cell and gene therapies with the material resources and services needed to implement or optimize a highly efficient G-Rex® based cell manufacturing platform. Qualifying programs can receive up to $300,000 in G-Rex® devices, critical reagents, capital equipment, application support, and manufacturing consultation services.

"Wilson Wolf is eager to participate in the G-Rex® Grant Program," said John Wilson, CEO of Wilson Wolf Manufacturing. "G-Rex® is used in nearly 50% of CGT clinical trials and four commercially approved T cell therapies. We hope everyone using G-Rex®, or considering G-Rex®, will take advantage of our extensive cell therapy manufacturing expertise. Time and money are the two most important things in short supply in this field and we can help fix that. When allowed to review batch records, we have a proven history of saving many months and millions of dollars while simultaneously increasing yield and potency."

"The G-Rex® Grant Program is a transformative initiative that will significantly reduce the barrier to entry for CGT institutions who seek access to our industry leading G-Rex® platform," said Josh Ludwig, Global Commercial Director at ScaleReady. "Time is the most valuable resource we all have. G-Rex® is the only integrated development and manufacturing platform in the world that provides continuity between the research, development, and manufacturing functions. G-Rex® platform continuity saves valuable time by ensuring that critical process parameters (CPPs) and critical quality attributes (CQAs) are conserved during the translation or troubleshooting process. By equipping researchers and developers with the best-in-class tools and expertise they need, we can accelerate the development and improve the manufacturability of these potentially lifesaving treatments."

"Bio-Techne is committed to providing researchers with the tools they need to develop groundbreaking therapies," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "The G-Rex® Grant Program aligns perfectly with this mission by supporting the development of cell and gene therapies that have the potential to revolutionize healthcare."

G-Rex® Grants will be awarded to applicants that provide a compelling overview of why a G-Rex® Grant would be beneficial, a strong willingness to work collaboratively to achieve program goals, a demonstrated track record of successful program management, and a provision of well understood deliverables.

The application process is designed to be simple and facilitate a collaborative discussion to refine potential program goals. By participating, recipients can expect faster and more cost-effective development timelines, a smoother transition from research labs to GMP manufacturing, and a stronger data package for IND applications. Ultimately, the program aims to expedite clinical data generation, reduce the complexity of the development process, increase the manufacturability, throughput and scalability of existing or future CGT programs, and increase patient access to these potentially lifesaving therapies.

Interested parties can learn more by following this link to initiate the G-Rex® Grant Program.

About ScaleReady
ScaleReady is a center of excellence that is bringing the future of cell and gene therapies to life with its powerful and versatile manufacturing platform and extensive array of collaborative CGT experts. Founded in 2020, ScaleReady is a joint venture of Bio-Techne, Fresenius Kabi, and Wilson Wolf that brings together tools and technologies for cell culture, cell activation, gene editing, and cell processing from each founding partner. Learn more at www.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: FacebookLinkedInTwitter 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.

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

Bio-Techne Logo (PRNewsfoto/Bio-Techne Corporation)

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SOURCE Bio-Techne Corporation

FAQ

What is the G-Rex® Grant Program announced by ScaleReady?

The G-Rex® Grant Program is a $20 million initiative aimed at advancing cell and gene therapy (CGT) development by providing academic and commercial institutions with up to $300,000 in G-Rex® devices, reagents, equipment, and support services.

How much support can qualifying institutions expect from the G-Rex® Grant Program?

Qualifying institutions can receive up to $300,000 in G-Rex® devices, critical reagents, capital equipment, application support, and manufacturing consultation services.

Which companies are collaborating on the G-Rex® Grant Program?

ScaleReady is collaborating with Wilson Wolf Manufacturing, Bio-Techne (NASDAQ: TECH), and CellReady on the G-Rex® Grant Program.

What are the goals of the G-Rex® Grant Program?

The G-Rex® Grant Program aims to expedite clinical data generation, reduce development complexity, increase manufacturability and scalability of CGT programs, and enhance patient access to potentially lifesaving therapies.

How can institutions benefit from the G-Rex® Grant Program?

Institutions can benefit through faster and more cost-effective development timelines, smoother transitions from research to GMP manufacturing, and stronger data packages for IND applications.

When was the G-Rex® Grant Program announced?

The G-Rex® Grant Program was announced on May 29, 2024.

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