Evotec adds cell therapy manufacturing facility with acquisition of Rigenerand
- EVOTEC’S EVOCELLS PLATFORM INTEGRATES INNOVATIVE OFF-THE-SHELF IPSC CELL THERAPY DISCOVERY WITH DEVELOPMENT AND MANUFACTURING
Octobre 18, 2021 Outsourced Pharma: Cell And Gene Start-Ups Need "CDMO 2.0"
By Louis Garguilo, Chief Editor, Outsourced Pharma
Try as I may, I can’t get Massimo Dominici to use the term “CDMO,” although that’s what we’re talking about.
At least I think that’s what we’re talking about.
Finally, he relents; instead of saying “partnerships” again, he references “CDMO 2.0” as a different breed of external organization, established to support cell and gene therapy (CGT) companies – a prelude partner before potentially utilizing larger, established CDMOs.
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Mesenchymal Stromal Stem Cells: Next Steps and Considerations for CGMP Manufacturing
Massimo Dominici is scientific founder of Rigenerand srl, a joint venture between RanD (a biomedical company producing bioreactors for liver support and chemohyperthermic technology for cancer) and experts in cell and gene therapy at the University of Modena and Emilia Region in Italy. Rigenerand develops and manufactures medicinal products for cell-therapy applications (primarily for regenerative medicine and oncology) and three-dimensional (3D) bioreactors as an alternative to animal testing for preclinical investigations. The company also produces its own pipeline of cell and gene therapies for cancer treatment and operates a contract development and manufacturing (CDMO) division that provides good manufacturing practice (GMP) support for scaling up of cell-based medicinal products. Headquartered in Medolla, Italy, Rigenerand is developing a proprietary gene therapy for treating patients with pancreatic ductal adenocarcinoma (PDAC). It has been granted orphan drug designation by both the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA), with a phase 1 clinical trial beginning this year. Read more
Rigenerand signs distribution partnership with Lacopa LLC for VITVO 3D cell culture technology
Lacopa has rights for distribution in Asian markets including Russia Modena, Italy, March 09, 2021 – Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announces the singing of a distribution agreement with Lacopa LLC. The agreement will enable Lacopa to distribute Rigenerand’s VITVO 3D cell culture technology across the Central Asian regions of Russia, Kazakhstan and Belarus. Rigenerand has developed VITVO as an innovative handheld bioreactor with an integrated scaffold for establishing an in vitro 3D cell culture model. It is expected that Lacopa will encounter most demand from Russian academic research teams as well as pharma companies in the region. VITVO’s 3D models will greatly enhance academic and pharma research and pre-clinical programs for cell and gene therapies. Lacopa specialists will actively work with a Rigenerand team to enhance the well-established Rigenerand distribution strategy for VITVO to specifically meet regional needs and requirements, based on an evaluation of regional client expectations in Central Asia. Read More
November 19, 2020 - World pancreatic Cancer Day
World pancreatic Cancer Day falls on the third thursday every year, which is November 19 in 2020. This is a day where people around the world will unite to Demand Better in the fight against the world’s toughest cancer. The World Pancreatic Cancer Coalition has brought together more than 60 organizations from 27 countries and six continents to raise awareness and inspire action on World Pancreatic Cancer Day. Through this combined effort, we are bringing greater attention, awareness, and better outcomes to this deadly disease. >> https://www.awarenessdays.com/awareness-days-calendar/world-pancreatic-cancer-day-2020/
genengnews.com: Improving Cell Therapy’s Supply Chain
Several elements of making cell therapies create significant obstacles in getting these treatments to more patients.
“A main challenge for cell therapies—autologous or allogeneic—is cryopreservation in the supply chain,” says Simona Guidi, business development director at Rigenerand. “Products have a very short shelf life, sometimes hours or days.”
That obstacle prevents many patients from getting such treatments. A potential solution involves getting the production closer to patients. “That is a big issue,” points out Guidi.
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Rigenerand commences 3D bioreactor development for cGMP extracellular vesicle exosomes (EV) production
Development supported by part of Horizon 2020 consortium grant Modena, Italy, July 8, 2020 - Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announces it 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. Rigenerand’s project development will be supported with part of a grant of EUR 4.4 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. The Biogenic Organotropic Wetsuits (Grant Agreement ID: 952183) project involves eleven organizations across seven countries in Europe. Rigenerand will contribute to the consortium its combination of expertise, technology and innovation focused on biomaterials, prototypes production and industrialization of cell culture devices and 3D cell cultures. Rigenerand 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 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. “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. “Despite a high demand in the market for 3D cell culture models to improve increased information compared to 2D models, 3D models are not yet routinely deployed,” said Giorgio Mari, Rigenerand CEO. “We will continue to develop 3D technologies, and maintain our market leading position by increasing collaborations with HTS technology developers and pharmaceutical firms who have technology that can work with VITVO. We are also collaborating with academic research units to develop new applications.” About Rigenerand Rigenerand SRL is a biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology and 3D bioreactors as alternative to animal testing for pre-clinical investigations. Rigenerand operates through three divisions: 1) a proprietary pipeline, developing and GMP manufacturing of cell and gene therapies for cancer treatment, 2) a CDMO division, providing GMP support for scale-up of cell based medicinal products for clinical and commercial purposes within fully equipped Grade A/B cleanrooms, and 3) a division developing 3D technologies for cell culture, developing and manufacturing 3D solutions for R&D diagnostics and pre-clinical purposes (VITVO®). Rigenerand is developing RR001, a proprietary ATMP gene therapy medicinal product for the treatment of pancreatic ductal adenocarcinoma (PDAC). RR001 has been granted an Orphan Drug Designation (ODD) by US-FDA and from the European Medicine Agency. The Clinical trial is expected to start in Q1 2021. Rigenerand is headquartered in Medolla, Modena, Italy, with more than 1,200 square metres of offices, R&D and quality control laboratories and a cell factory of 450 square metres of sterile cleanroom (EuGMP Grade-B) with BSL2/BSL3 suites for cell and gene therapies manufacturing. It combines leaders and academics from biopharma and medical device manufacturing sectors. Contact Information: Image Box PR Neil Hunter / Michelle Boxall Tel +44 (0)20 8943 4685 neil@ibcomms.agency / michelle@ibcomms.agency
Rigenerand receives regulatory approval for gene therapy production
Authorization enables Rigenerand to enter into clinic and offer CDMO services and consultancy to cell and gene therapy sector
Modena, Italy, June 2, 2020 - Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announces it has received authorization from the Italian Medicine Authority (AIFA) to produce gene therapy medicinal products for clinical purposes. This authorization enables Rigenerand to manufacturer its own autologous gene therapy medicinal product (RR001) for the treatment of pancreatic cancer. It also authorizes the company to start its phase I first-in-man clinical trial of RR001, now expected to start in Q1, 2021. RR001 has been granted Orphan Drug Designation (ODD) by both the US FDA (Food and Drug Administration) and European Commission COMP (Committee for Orphan Medicinal Products). This ODD offers the opportunity for Rigenerand to request an accelerated assessment procedure and quicker development pathways towards a marketing authorization in the US and EU. Rigenerand will also now offer direct GMP CDMO services to international and Italian partners in clinical development of cell and gene therapy products (ATMPs). The company will utilise its experience from its drug development and diagnostic arms to deliver a science-based approach to its GMP manufacturing services and cell-based medicinal products development. Rigenerand plans to expand its manufacturing facility from five sterile clean rooms suits. This will be by implementing further closed system and isolator technology in pre-designated areas in its facilities. The five sterile cleanrooms are within the Rigenerand GMP facility, which contains a Biosafety Level 3 (BSL3) negative pressure area, suitable to handle genetically modified microorganisms (MOGM), viruses and Risk Group 3 microorganisms, as well as a Biosafety Level 2 (BSL2), positive pressure area: suitable to manipulate non-infectious cell based products and Risk Group 2 microorganisms. Rigenerand’s cleanroom technology offers the flexibility to scale-up the processes from academic / hospital laboratories, and the feasibility of technology transfer of manufacturing processes from other cell factories in order to expand their process capability. In addition, Rigenerand is now authorized to deliver consultancy to biotechnology and pharmaceutical companies on cell and gene therapy development and manufacturing. This consultancy includes expanding process capabilities and developing early-stage cell and gene therapy medicinal products for clinical purposes. As the cell and gene therapy sector continues to grow, with increased numbers of therapies moving through clinical development and onto commercialization, demand for CDMO services will continue to grow. There is an increased demand for global networks of CDMO GMP cell and gene therapy manufacturing. This calls for an improved capacity to treat patients whilst reducing logistical complexities, issues, risks, and costs. “The regulatory approval for Rigenerand to produce gene therapies for clinical development now enables Rigenerand to enter the clinic with its own gene therapy product to target pancreatic cancer,” said Massimo Dominici, scientific founder, Rigenerand. “Combined with the Orphan Drug Designation, the approval will enable Rigenerand to choose an accelerated pathway to bring a gene therapy approach to pancreatic cancer patients with little alternative therapeutic option.” “The authorization is also essential in allowing Rigenerand to offer its much needed GMP CDMO services to the wider cell and gene therapy sector,” said Giorgio Mari, Rigenerand CEO. “We will be expanding our CDMO facility to cater for increasing demand. Operating as both a developer with a clinical pipeline as well as a CDMO has resulted in an unrivalled blend of expertise for us to offer to partners and the wider cell and gene therapy industry.” About Rigenerand Rigenerand SRL is a biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology and 3D bioreactors as alternative to animal testing for pre-clinical investigations. Rigenerand operates through three divisions: 1) a proprietary pipeline, developing and GMP manufacturing of cell and gene therapies for cancer treatment, 2) a CDMO division, providing GMP support for scale-up of cell based medicinal products for clinical and commercial purposes within fullyequipped Grade A/B cleanrooms, and 3) a division developing 3D technologies for cell culture, developing and manufacturing 3D solutions for R&D diagnostics and pre-clinical purposes (VITVO®). Rigenerand is developing RR001, a proprietary ATMP gene therapy medicinal product for the treatment of pancreatic ductal adenocarcinoma (PDAC). RR001 has been granted an Orphan Drug Designation (ODD) by US-FDA and from the European Medicine Agency. The Clinical trial is expected to start in Q1 2021. Rigenerand is headquartered in Medolla, Modena, Italy, with more than 1,200 square metres of offices, R&D and quality control laboratories and a cell factory of 450 square metres of sterile cleanroom (EuGMP Grade-B) with BSL2/BSL3 suites for cell and gene therapies manufacturing. It combines leaders and academics from biopharma and medical device manufacturing sectors.
ESMH - Alternative approaches to animal testing
In 1959, The Principles of Humane Experimental Technique was published by Russell and Burch, introducing the 3Rs concept (replacement, reduction, and refinement) regarding animal use in the scientific community. Just over 60 years later, it is timely to review progress to date and the future outlook regarding alternative approaches to animal testing.
The US Environmental Protection Agency (EPA) announced elimination of all mammal study requests and funding by 2035, and the Dutch Minister for Agriculture aims for the Netherlands to become the ‘world leader in innovations without laboratory animals by 2025’. These ambitious objectives by the Netherlands and the US are backed also at an EU level, with both citizens and industry anticipating significant reductions in the coming years.Read more