The $20 million grant will provide cell and gene therapy (CGT) focused academic institutions and biotech firms with resources and services to optimize CGT production. Qualifying candidates will receive up to $300,000 in G-Rex devices, critical reagents, equipment, application support, and manufacturing consultation services.
According to Wolf, its G-Rex platform, which stands for gas permeable rapid expansion, manufactures immune cells such as T cells, natural killer cells, and hematopoietic cells. As a production platform, G-REX works by letting cells obtain the exact amount of nutrients and oxygen they need without complex instrumentation and monitoring. It is used in nearly 50% of CGT clinical trials and four commercially approved T- cell therapies, the firm said.
The grants will be awarded to applicants that provide a compelling overview of why a G-Rex grant would be beneficial for them. The program aims to advance 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.
BioProcess Insider spoke to John Wilson, CEO, ScaleReady and Wilson Wolf, about the grant program, G-Rex platform, and its wider impact on the advanced therapy industry.
John Wilson (JW): G-Rex is the only integrated development and production platform to provide continuity between research, development, and manufacturing functions. It saves valuable time by ensuring that critical process parameters (CPPs) and critical quality attributes (CQAs) are conserved during translation or troubleshooting. Use of G-Rex helps establish a seamless link via platform continuity between the research labs, process development labs, and the GMP manufacturing center. This enables faster translation of new therapies into the clinic, by quickly and inexpensively implementing an optimized manufacturing platform that is suitable for each stage from discovery to commercial production.
JW: Through the program, we will provide recipients with a highly efficient G-Rex-based cell manufacturing platform, and/or optimize an existing G-Rex-based platform quickly and at low cost. Because of its unique technical attributes, G-Rex allows for linear scalability across its line, simplifying scale-up. With G-Rex making several commercial drug products, producing cells for nearly 50% of CGT clinical trials, and now becoming widely accepted as an all-in-one device, it’s time to apply automation selectively and thoughtfully. The simplicity of G-Rex allows us to implement the type of automation solutions that occur millions of times a day in a wide variety of mature industries.
JW: The recipients will be academic and commercial institutions engaged in pre-clinical research, process development, and/or cGMP manufacture of cell and gene-modified cell therapies
JW: To be eligible for the program, recipients must be engaged in research and development of CGT therapies based on or derived from T cells, NK cells, HSCs, etc. They must be working towards, or have, an existing Investigational New Drug (IND) application, and be interested in quickly establishing an optimized cGMP manufacturing process at low cost with minimal investment required.
We will award G-Rex grants to applicants with a compelling overview of the need, a collaborative spirit and strong willingness to interact with ScaleReady to achieve program goals, who can demonstrate the necessary wherewithal in program management and identify clear deliverables.
JW: Under the G-Rex grant program, ScaleReady will provide the most appropriate combination of devices, reagents, and consulting support. This encompasses Wilson Wolf’s G-Rex devices, including well plates, bioreactors, the GatheRex Cell Harvest Pump and ancillary products, as well as Bio-Techne’s research grade and GMP reagents and cell culture media, and the TcBuster transposon/transposase system.
In terms of services, ScaleReady may provide G-Rex optimization services, technical application support, and/or marketing support, while CellReady may offer process development and manufacturing services and consultation.
JW: The G-Rex grant will provide each recipient between $5,000 and $300,000 worth of materials and services from the participating companies, along with free consulting support, for up to 18 months – or longer if the partners mutually agree. At the onset of the program, ScaleReady will work collaboratively with the recipient during a series of discovery sessions to create a thorough understanding of the recipient’s goals. To achieve them, ScaleReady will then interact with Wilson Wolf, Bio-Techne, CellReady and the recipient to orchestrate a program plan.
JW: We expect access to G-Rex through the grant program will save valuable time (and money) by inheriting an expeditious pathway to clinical inflection points.
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