ScaleReady announces the inaugural G-Rex® Grant has been awarded to Stanford Medicine Laboratory for Cell and Gene Medicine
PR Newswire
Tue, Aug 27,
ST. PAUL, Minn., Aug. 27, 2024 /PRNewswire/ -- ScaleReady™, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation (NASDAQ: TECH) and CellReady™, today announced that Dr. Steve Feldman, Scientific Director and Site Head of Stanford Medicine's Laboratory for Cell and Gene Medicine (LCGM), has been awarded the inaugural G-Rex® Grant. Dr. Feldman's $300,000 G-Rex Grant will enable expeditious development of Stanford Medicine's LCGM's G-Rex platform for CAR-T cell therapy manufacturing, which will be offered to internal investigators and external developers who are seeking its development and manufacturing services.
"Stanford's LCGM anticipates a need to support a greater number of clinical trials and the G-Rex Grant will be used to help meet that need," said Dr. Feldman.
"We are honored to award the inaugural G-Rex Grant to Dr. Feldman and his team at Stanford Medicine LCGM. Stanford University is a world-class institution with faculty who have a reputation for innovative and ground-breaking achievements. Their work aligns with Wilson Wolf's mission of bringing hope to cancer patients, one G-Rex at a time" said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex.
As part of the G-Rex Grant, Stanford Medicine LCGM will deploy their G-Rex-centric manufacturing process in an upcoming Phase 1 trial for GPC2+ pediatric neuroblastoma and medulloblastoma. Previously, the FDA had recommended sponsors develop and implement potency assays earlier in the clinical trial process. With that objective, Stanford Medicine LCGM plans to implement Bio-Techne's leading automated multiplexing immunoassay platform, Ella™, as a potency assay for final drug product release.
Furthermore, Stanford Medicine LCGM will collaborate with CellReady, the world's first and only G-Rex based contract development and manufacturing organization (CDMO), to leverage their proven capacity to quickly create G-Rex master batch records that establish manufacturing simplicity, efficiency, and repeatability.
Additionally, Stanford Medicine LCGM plans to further develop a novel technology (developed by Wilson Wolf) that enables closed-system T cell purification to be done directly in a G-Rex device, without the need for expensive ancillary equipment.
ScaleReady's G-Rex Grant Program is a $20M initiative to advance the state of cell and gene-modified cell therapy (CGT) development and manufacturing by awarding individual Grant Awards 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. |
