G-Rex Grant Program

The G-Rex Grant Program is a transformational initiative undertaken by ScaleReady, in collaboration with Wilson Wolf, Bio-techne, and CellReady, to benefit the cell & gene therapy community in the following ways:

Enhancing company valuation by expediting and cost reducing the path to meaningful clinical data.
Quickly and inexpensively implement an optimized G-Rex® centric manufacturing platform that is suitable for each stage of the path to commercial drug production.
Establishing a seamless link, via G-Rex® platform continuity, between the research labs, process development labs, and the GMP manufacturing center to enable faster translation of new therapies into the clinic.
Increasing patient access to cell and gene modified cell therapies by making significant reductions in process complexity.
Increasing the value of academic institution’s technology by allowing licensor’s to save valuable time and money by inheriting an expeditious pathway to clinical inflection points.

G-Rex Grant Program Overview

The G-Rex® Grant Program is a $42,000,000 initiative undertaken by ScaleReady, in collaboration with Wilson Wolf, Bio-Techne, and CellReady to benefit the cell and gene-modified cell therapy community.

The G-Rex® Grant Program is unique and unlike any other grant program. G-Rex® Grant Recipients will not be burdened with inflexible timelines, bureaucratic constraints, micromanagement, or invasive oversight.

The G-Rex® Grant Program is intended to be simple, flexible, and easily accessible from initiation through completion. The G-Rex® Grant Program will be successful due to a partnership based on mutual trust, respect, and understanding.

The purpose of the G-Rex® Grant Program is to provide interested academic and commercial institutions engaged in pre-clinical research, process development, and/or cGMP manufacture of cell and gene-modified cell therapies (the “Recipient”) with the devices, reagents, and operational know-how to:

Implement a highly efficient G-Rex® based cell manufacturing platform and/or
Optimize an existing G-Rex® based cell manufacturing platform quickly and at low cost.

Key Features

The G-Rex® Grant will provide each Recipient between $5,000 and $300,000 worth of materials and services, along with free consulting support from ScaleReady G-Rex® Optimization Specialists, for up to 18-months* (the “Collaboration Period”) to any academic or commercial institution that meets the criteria outlined below. The duration of the Collaboration Period may be extended upon mutual agreement by the parties.

At the onset of the G-Rex® Grant Program:

ScaleReady will work collaboratively with the Recipient during a series of discovery sessions to create a thorough understanding of the Recipient’s goals.ScaleReady will interact with Wilson Wolf, Bio-Techne, CellReady and the Recipient to orchestrate a G-Rex® Grant Program Plan that aims to achieve the Recipient’s goals.

Under the G-Rex® Grant Program, ScaleReady will provide the most appropriate combination of devices, reagents, and consulting support as follows:

Wilson Wolf
- G-Rex® devices including G-Rex® well plates, G-Rex® bioreactors (including closed system models), and the GatheRex® Cell Harvest Pump
- G-Rex® ancillary products
Bio-Techne
- RUO and GMP Reagents
- RUO and GMP cell culture media
- TcBuster® non-viral (transposition) gene editing technology
ScaleReady
- G-Rex® Optimization Services
- Technical Application Support
- Marketing Support
CellReady
- Process Development and Manufacturing Services and Consultation

During the Collaboration Period, the G-Rex® Grant Recipient and ScaleReady will work together to meet the Recipient’s program goals, which will typically include creating a process and data package sufficient:

To be included in the CMC section of an applicable IND(s), or
Used to support further research or collaborative efforts in the Recipient institution.

Eligibility

To be eligible for the G-Rex® Grant Program, a Recipient must satisfy the following criteria:

Be engaged in research and development of cell and gene-modified cell therapies based on or derived from T cells, NK cells, HSCs, or the like.
Be working towards, or have, an existing Investigational New Drug (IND) application.
Be interested in quickly establishing an optimized cGMP manufacturing process at low cost with minimal investment required.

Application and Award Process

The Application and Award Process:

The application process for a G-Rex® Grant is intended to be very easy and will be initiated by a simple form that will lead to a deeper dialogue with ScaleReady to help hone the application to a form suitable for receipt of a G-Rex® Grant.

G-Rex® Grants will be awarded to applicants that provide ScaleReady with:

A compelling overview of why a G-Rex® Grant would be beneficial.
A strong willingness to interact with ScaleReady to achieve program goals.
Confidence that the recipient has wherewithal in program management.
The collaborative nature of the applicant.
Provision of a well understood set of G-Rex® Grant deliverables

Once a G-Rex® Grant is Approved:

Upon G-Rex® Grant approval, ScaleReady will provide a high-level Non-Binding Memorandum of Understanding to the Recipient indicating the loosely agreed upon goals, estimated timelines, deliverables, actions, and respective responsibilities that were identified in the discovery phase.

•

Of importance, the Non-Binding Memorandum of Understanding is a guideline document only

•

The relationship between a G-Rex® Grant Recipient and ScaleReady is based entirely on mutual trust and understanding that flexibility will be needed to reach the Recipient’s program goals.

•

During the Collaboration Period, the Recipient and ScaleReady will work openly and collaboratively to achieve the mutually agreed upon outcomes of the G-Rex® Grant.

Collaboration Period

Once a G-Rex® Grant is Approved:

Of importance, the Non-Binding Memorandum of Understanding is a guideline document only
The relationship between a G-Rex® Grant Recipient and ScaleReady is based entirely on mutual trust and understanding that flexibility will be needed to reach the Recipient’s program goals.
During the Collaboration Period, the Recipient and ScaleReady will work openly and collaboratively to achieve the mutually agreed upon outcomes of the G-Rex® Grant.

G-Rex Grant Partner Exclusive Offers

ScaleReady has enlisted a legion of like-minded collaborators to bring additional value to help our G-Rex® Grant Recipients save time and money. All G-Rex® Grant Recipients will be provided a catalogue of exclusive offers from our official G-Rex® Grant Partners.

Exclusive offer on the ExPERT GTx ^TM Electroporation Instrument

Benefit to G-Rex User: The ExPERT GTx ^TM Electroporation Instrument can maintain a fully closed and sterile fluid path to G-Rex bioreactors, streamlining the drug substance’s (DS) flow through the non-viral assembly line. Like G-Rex, the ExPERT GTx ^TM Electroporation Instrument is used in commercial of FDA approved