October 12, 2021 Outsourced Pharma: Creating The Culture Of Cell Culture

By Louis Garguilo, Chief Editor, Outsourced Pharma Massimo Dominici is co-founder of Rigenerand, a cell-and-gene therapy (CGT) company in Modena, Italy; full-time professor at University of Modena and Riggio Emilia; advisor to the World Health Organization (WHO); former Chairman of the International Society for Cell And Gene Therapy (ISCT); and licensed oncologist.Read more

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

Aboutpharma March, 1 - 2021: Bioplastiche, C-Pap, cellule e “vecchi” polimeri: il futuro visto da Mirandola

Il viaggio di AboutPharma nell’Italia che produce dispositivi medici comincia dal primo distretto industriale d’Europa. Che oggi guarda anche alle terapie avanzate e ai materiali biocompatibili, forte di una consolidata tradizione, manodopera esperta e una rete di imprese che mette insieme grandi multinazionali e pmi. Dal numero 186 del magazine

Nel futuro ci sono le bioplastiche. La transizione ecologica, invocata dai governi occidentali e sostenuta dai programmi di sviluppo come il New Green Deal dell’Unione europea, ha una importantissima sponda italiana a Mirandola, in provincia di Modena, nel cuore del più importante polo produttivo europeo di dispositivi medici. Forti di una lunga e ininterrotta tradizione nella ricerca e sviluppo di polimeri impiegati nella biomedicina, le aziende della “Minneapolis italiana” guardano al futuro per ridurre l’impatto del “medical waste” e sfornare tecnologia ad altissimo valore aggiunto. Lo racconta Giorgio Mari, biotech innovation manager e responsabile di progetti di ricerca e del rapporto con le aziende, all’interno del Tecnopolo “Mario Veronesi” di Mirandola. Mari è anche ceo di Rigenerand, società biotech con sede a Medolla, che sviluppa terapie basate su cellule staminali per combattere tumori rari. “Per quel che riguarda il settore del biomedicale tutti i dispositivi monouso che produciamo sono in materiale polimerico. L’utilizzazione dei polimeri è la stessa di qualche decennio fa. Lo è per via della loro caratteristica di biocompatibilità, per i tempi di contatto prolungati, per la lavorabilità e l’assemblaggio. Nel nostro campo il riuso è impossibile, perché il dispositivo viene a contatto con il corpo umano, e quindi, una volta utilizzato, non si può pensare di riciclarlo”. Continue reading

Covid: cura con le cellule staminali per spegnere il virus Sars-CoV-2. Via ai test

Lo studio partirà a breve e sarà coordinato dall'Ausl di Modena e UniMoRe. L'infusione dovrebbe bloccare l'infiammazione polmonare, ridurre la permanenza in terapia intensiva e i danni a lungo termine

Modena, 26 gennaio 2021 - Per curare il Covid sono stati utilizzati diversi farmaci e varie cure sono state sperimentate in questi mesi di pandemia, ma nessuna di queste ha finora dimostrato di essere determinante. Da oggi c’è un motivo in più per credere che questo maledetto virus potrà essere sconfitto. Dai laboratori del Policlinico di Modena, infatti, è iniziata una sperimentazione che prevede l’utilizzo di cellule staminali (video): "Un ulteriore tentativo, forse più potente di quelli finora tentati, per cercare di spegnere quell’infiammazione che è la causa di una sequenza di eventi che porta al crash del sistema respiratorio, al rischio delle complicazioni e purtroppo alla morte del paziente". Lo spiega il direttore della Struttura complessa di malattie dell’apparato respiratorio dell’Azienda ospedaliero-universitaria di Modena, Enrico Clini (video), che fa parte della cordata di aziende e ospedali chiamati ad applicare su una sessantina di pazienti quello che è emerso dagli studi. Tempo sei mesi per capire se questo tipo di cura avrà ottenuto i suoi risultati. image «Per la prima volta in Italia – dice Massimo Dominici (video), direttore della Struttura complessa di oncologia dell’Azienda ospedaliero-universitaria di Modena – abbiamo avuto la forza di mettere assieme cinque strutture che producono cellule per sottoscrivere un unico protocollo clinico, con delle caratteristiche ben definite per quanto riguarda il paziente e con una unicità legata al fatto che potremo confrontare i tipi diversi di cellule all’interno della sperimentazione clinica controllata». Oltre al Policlinico di Modena – che è il coordinatore del progetto Rescat – sono coinvolti gli ospedali Meyer e Careggi di Firenze, il Policlinico Irccs Ca’ Granda di Milano con l’Ospedale Covid di Milano Fiera, l’ospedale San Gerardo di Monza con la Fondazione Centro di ricerca Tettamanti e con l’università Milano-Bicocca, l’azienda ospedaliera universitaria integrata di Verona e l’azienda ospedaliera di Vicenza. Continua a leggere>

Bone Therapeutics and Rigenerand sign partnership for cell therapy process development

Gosselies, Belgium and Modena, Italy, 14 January 2021, 7am CETBONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, today announce the signing of a first agreement for a process development partnership. “Allogeneic mesenchymal stem cell (MSC) therapies are currently being developed and evaluated in numerous clinical studies covering diverse therapeutic areas such as musculoskeletal, lung, liver, cardiovascular and autoimmune diseases at an incredible pace. Advances in process development to scale up these therapies could have major impacts for both their approval and commercial viability. This will be essential to bring these therapies to market to benefit patients as quickly as possible,” said Miguel Forte, CEO, Bone Therapeutics. “Hence, whilst Bone Therapeutics is driving on its existing clinical development programs, we have signed a first formal agreement with Rigenerand as a fellow MSC-based organization. This will result in both companies sharing extensive expertise in the process development and manufacturing of MSCs and cell and gene therapy medicinal products. Bone Therapeutics also selected Rigenerand to partner with for their additional experience with wider process development of advanced therapy medicinal products (ATMPs), including the conditioning and editing of MSCs. Rigenerand was founded by Massimo Dominici, a world opinion leader in the cell therapy with an unparalleled MSC expertise and knowledge.” The scope of collaborations between Bone Therapeutics and Rigenerand aims to focus on different aspects of product and process development for Bone Therapeutics’ expanding therapeutic portfolio. Rigenerand will contribute to improving the processes involved in the development and manufacture of Bone Therapeutics’ MSC based allogeneic differentiated cell therapy products as they advance towards patients. The first collaboration between the two organizations will initially focus on augmented professional bone-forming cells – cells that are differentiated and programmed for a specific task. There is also potential for Bone Therapeutics to broaden its therapeutic targets and explore new mechanisms of action with potential gene modifications for its therapeutic portfolio. In addition to Rigenerand’s MSC expertise, Bone Therapeutics also selected Rigenerand as a partner for Rigenerand’s GMP manufacturing facility. This facility, situated in Modena, Italy, has been designed to host a number of types of development processes for ATMPs. These include somatic, tissue engineered and gene therapy processes. These multiple areas of Rigenerand capabilities enable critical development of new processes and implementation of the gene modification of existing processes. In addition, Rigenerand has built considerable experience in cGMP manufacturing of MSC-based medicinal products, including those that are genetically modified. “Process development and manufacturing is a key part of the development for ATMPs internationally. Navigating these therapies through the clinical development phase and into the market requires a carefully considered process development pathway,” said Massimo Dominici, scientific founder, Rigenerand, professor of medical oncology, and former President of the International Society for Cell & Gene Therapy (ISCT). “This pathway needs to be flexible, as both the market and materials of these therapies continues to evolve alongside an improved clinical efficacy.” “Rigenerand will offer considerable input from its experience of MSC-based therapies to enable Bone Therapeutics to keep and further accelerate the pace in development of the product processes of its MSC based allogeneic differentiated cell therapy as they advance towards patients,” said Giorgio Mari, CEO, Rigenerand. “We will continue to use our MSC expertise in the development of Rigenerand’s own products, as well as in process development and manufacturing cell and gene therapies for partner organizations across the globe.” About Bone Therapeutics Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation. Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. Bone Therapeutics’ core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics’ scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental. Bone Therapeutics’ cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at www.bonetherapeutics.com. 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 Q2 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

Global Cell Culture Market Trends: Product Development For 3D Cell Culture

The Business Research Company’s Global Cell Culture Market Report 2020-30: Covid 19 Growth And Change LONDON, GREATER LONDON, UK, October 12, 2020 /EINPresswire.com/ -- The development of products for 3D cell culture by companies operating in the cell culture market is gaining significant popularity. A 3D cell culture is an artificially created environment in which biological cells are permitted to grow or interact with their surroundings in all three dimensions, similar to how they would in a living organism. For instance, in July 2020, Rigenerand, an Italian company engaged in the production of innovative cell-based technology products for regenerative medicine and oncology, launched a 3D bioreactor called VITVO handheld bioreactor to offer increased usability, sizing, closed system, and flexibility for 3D cell culture technologies. Similarly, Jellagen, a UK-based marine biotechnology company, launched JellaGel, a jellyfish collagen hydrogel, suitable for 3D cell culture and tissue engineering.

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