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The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.
Rigenerand, a Modena, Italy-based biotech company specializing in medicinal products for cell therapy applications, has begun development of a novel 3D bioreactor and pipeline specifically designed for the incremental production of extracellular vesicles exosomes (EVs) in a current good manufacturing practices (cGMP) environment. The development will be supported with part of a EUR 4.4-million (US$5.1-million) grant from Horizon 2020 for the H2020-EU.1.2.2.-FET Proactive program, awarded to the Biogenic Organotropic Wetsuits project. This project comprises a consortium of companies, including Rigenerand.
The Biogenic Organotropic Wetsuits project involves 11 organizations across seven countries in Europe. Rigenerand will contribute its combination of expertise, technology, and innovation focused on biomaterials, prototypes production, and industrialization of cell-culture devices and 3D cell cultures to the consortium, the company said in a July 8, 2020 press release. Rigenerand will start developing novel ways of improving current EV cGMP production technologies, which will ultimately aim to produce EV clinical batches to be used as drug substances for cell-free therapy-based medicinal products.
The project is due to start in the fourth quarter of 2020. By the second quarter of 2021, Rigenerand plans to have developed the isolation and expansion of a human cellular source (EDT-MSC) suitable for the production of immune-ghost EVs as well as the separation and production of suitable amounts of EV for characterization and pre-clinical application.
“This project will contribute to the urgent medical need of increasing EV production. It will enable Rigenerand to develop pre-conditioning approaches that are critical to providing solutions to these challenges,” said Massimo Dominici, scientific founder, Rigenerand, in the company press release. “The activity for this consortium will also enable Rigenerand to develop platforms for new therapeutic solutions, covering a range of clinical applications, including oncology and regenerative medicine to medical devices.”
The Rigenerand 3D bioreactor for EV production will be based on its proprietary VITVO technology. VITVO is a handheld bioreactor, with an integrating scaffold for the establishment of a 3D cell culture model. It is already used for highly predictive pre-clinical testing and has been specifically designed to offer an increase to the market in usability, sizing, closed system performance, and flexibility for 3D cell culture technologies.