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Italy: Production of 3D Bioreactor Rigenerand to Contribute EV cGMP Technologies to European Project Consortium

Editor: MA Alexander Stark

Italian biotech company Rigenerand has commenced development of a novel 3D bioreactor and pipeline, specifically designed for the incremental production of extracellular vesicles exosomes (EVs) in a cGMP environment. The company’s project development will be supported with part of a grant of $ 5 million 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 involving Rigenerand.

Rigenerand commences 3D bioreactor development for cGMP extracellular vesicle exosomes (EV) production
Rigenerand commences 3D bioreactor development for cGMP extracellular vesicle exosomes (EV) production
(Source: Public Domain / Pixabay )

Modena/Italy — The Biogenic Organotropic Wetsuits (Grant Agreement ID: 952183) project involves eleven organizations across seven countries in Europe. The aim of the consortium is to contribute to the urgent medical need of increasing EV production. The Italian biotech company Rigenerand is part of this consortium and will contribute its combination of expertise, technology and innovation focused on biomaterials, prototypes production and industrialization of cell culture devices and 3D cell cultures. The company will start developing novel ways of improving current EV cGMP production technologies. These technologies ultimately aim to EV clinical batches to be used as drug substances for cell-free therapies medicinal products.

The project is due to start activity in Q4 2020. By Q2 2021, Rigenerand is planning 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 enable Rigenerand to develop pre-conditioning approaches that are critical to providing solutions to these challenges,” said Massimo Dominici, scientific founder, Rigenerand. “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. It has been specifically designed to offer an increase to the market in usability, sizing, closed system, and flexibility for 3D cell culture technologies.

Vitvo has been extensively used for pre-clinical development of its autologous gene therapy medicinal product RR001, contributing to evaluation of the action and efficacy of the drug. It also allows the reduction of the number of animals employed in the experimentation for dose finding studies. Vitvo has also been used in a variety of assays focusing on oncology. The efficacy of chemotherapy, biologics and cell-based anti-cancer agents has been tested by comparing Vitvo with an in vivo preclinical xeno-transplant model. Notably, the system was challenged using primary tumor cells harvested from lung cancer patients as an innovative predictive functional assay for cancer responsiveness to a checkpoint inhibitor, such as nivolumab. The results suggest Vitvo as a 3D in vitro model for pre-clinical testing with a possible relevant impact in other areas external to oncology.

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