WINSTON-SALEM, NC, September 12, 2023 – When the RegenMed Development Organization (ReMDO) offered its grant opportunity related to regenerative medicine manufacturing and commercialization, the result exceeded expectations.
The Regenerative Medicine Manufacturing grant call encouraged small, medium, and large companies to submit letters of interest with an accompanying white paper that addressed a gap in technical capabilities for one or more of the following topic areas: Cell and Biomaterial Manufacturing, Standards and Quality Control, Additive Manufacturing and Artificial Intelligence (AI) and Automation.
The grant opportunity will create a continued impact on the rate of clinical translation for regenerative medicine therapies and the commercialization of regenerative medicine products within the global market.
The award recipient companies — Phase Holographic Imaging (PHI), BioSpherix, SAS Institute and QIAGEN — created a strategic technology development collaboration/alliance that will advance biomanufacturing in the Regenerative Medicine Hub and the region. Award amounts ranged from $50,000 to $200,000.
Through the alliance, the companies are creating the AI-based process control tools needed for automated biomanufacturing of cell-based therapies, resulting in more cost-effectiveness with superior efficacy and safety. Supported work utilizes ReMDO’s state-of-the-art facilities and Test Bed.
The RegenMed Hub is a regenerative medicine ecosystem powered by ReMDO and WFIRM and located in the Innovation Quarter, an epicenter of highly interactive science and technology companies and resources. The RegenMed Hub offers companies access to unparalleled resources to advance education, products, and manufacturing with the ultimate goal of improving patient care through ReMDO’s RegeneratOR program which includes the Test Bed, the Innovation AcceleratOR and a workforce development program.
“By offering a grant opportunity to focus on manufacturing gaps, we can help get the right companies and entrepreneurs involved to help drive the need to successfully translate regenerative medicine to clinical practice and get products and technologies to the global market quickly,” said ReMDO Chief Technology Officer Joshua Hunsberger, PhD.
Cell therapies are today cultured and manufactured in an open laboratory environment. For this alliance, BioSpherix is providing a sealed, sterile and cell-friendly environment where cells are cultured at controlled temperature, oxygen and CO2 levels without human contact.
The close to 12,000 employees of the SAS Institute supply analytics and data management software to over 80,400 business, government and university sites. SAS provides the AI expertise and software infrastructure to automatically analyze the wealth of data collected by the QIAGEN and PHI instrumentation. The analysis result will be fed back to continuously control the complex biomanufacturing process.
The 6,000-employee strong QIAGEN is providing the DNA, RNA and protein molecular data it offers to more than 500,000 customers around the globe. Equally important, PHI is providing non-invasive single-cell imaging data quantifying cellular behavior and morphology without using compromising reagents.
“The vision for the RegenMed Hub and its programs is coming to fruition,” said Anthony Atala, MD, director of WFIRM. “When companies like these team up to solve biomanufacturing problems, everyone benefits.”
About the RegenMed Development Organization
The mission of the RegenMed Development Organization (ReMDO) is to accelerate the discovery and translation of regenerative medicine therapies. ReMDO is a 501(c)3 non-profit organization that manages a clinical translation initiative that includes thought leaders, representatives from leading US research centers, government representatives, and companies of all sizes. ReMDO conducts research to de-risk technologies and speed up the translation of regenerative medicine to clinical practice and to the global market. ReMDO manages the world’s first and only professional organization dedicated solely to advancing the regenerative medicine field, the Regenerative Medicine Manufacturing Society (RMMS), and the Regenerative Medicine Manufacturing Innovation Consortium (RegMIC), which manages a private-public partnership of industry and academic members focused on scaling up technologies.
About the Wake Forest Institute for Regenerative Medicine
The Wake Forest Institute for Regenerative Medicine is recognized as an international leader in translating scientific discovery into clinical therapies, with many world firsts, including the development and implantation of the first engineered organ in a patient. Over 400 people at the Institute, the largest in the world, work on more than 40 different tissues and organs. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the Institute. WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs – and 15 different applications of cell/tissue therapy technologies, such as skin, urethras, cartilage, bladders, muscle, kidney, and vaginal organs, have been successfully used in human patients. The Institute, which is part of Wake Forest School of Medicine, is located in the Innovation Quarter in downtown Winston-Salem, NC, and is driven by the urgent needs of patients. The Institute is making a global difference in regenerative medicine through collaborations with over 400 entities and institutions worldwide, through its government, academic and industry partnerships, its start-up entities, and through major initiatives in breakthrough technologies, such as tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.
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