Next generation manufacturing
solutions for advanced therapies
DESCRIPTION
Medicine is entering a new phase: cells have become living drugs and several new therapies are proving to be safe and efficacious. However, significant challenges still need to be tackled to make more therapies available to patients. Conventional methods imply low productivity, low scalability, high infrastructure and labor costs which translate into a major barrier to commercialization.
VivaBioCell offers innovative solutions to support ATMP developers to manufacture their products in a robust, controlled, and cost-effective way. At the same time, we can establish partnership agreements to facilitate therapy adoption into new markets, including EU and US, ensuring protection of clinical and manufacturing IP.
This strategy enables therapy availability to wider patient populations and creates new revenue opportunities for the therapy owners.
The flexibility of our NANT001 system allows to automate manufacturing processes for multiple types of cell-based and cell-derived products. Current applications include regenerative medicine products for osteoarthritis using bone marrow- and adipo-derived MSCs, as well as natural killer cell-based immunotherapy products for the treatment of cancer.
VivaBioCell is part of NantCell, a subsidiary of NantWorks LLC, which vision supports an ecosystem of companies focused on the discovery and development of disease treatments through innovative, cell-based therapies. Fact-based and solution driven, each of NantWorks’ division companies operates at the intersection of innovation and infrastructure.
INNOVATIVE ASPECTS AND MAIN ADVANTADGES
We are keen to partner with new therapy owners/ATMP developers, from early to clinical stages. We offer innovative solutions to manufacture ATMPs in a robust, controlled, and cost-effective way, ensuring protection of clinical and manufacturing IP. At the same time, our Group can establish partnership agreements to facilitate therapy adoption into new markets, including EU and US. This approach enables wider therapy availability and creates new revenue opportunities for therapy owners.
Based on our expertise in process development and NANT 001 flexibility, we are able to tailor our bioreactor to translate traditional somatic cell-based manufacturing into robust bioprocessing solutions and meet customer needs. At the same time, NANT001 facilitates Regulatory and QA compliance, increased productivity and scalability, whilst reducing costs.
NANT001 ENABLES SCALABLE CELL MANUFACTURING FOR PERSONALIZED ADVANCED THERAPIES
NANT001 is an automated, closed, bench-top cell culture system that enables to achieve cells in therapeutic quantities at viable cost while meeting regulatory requirements and cGMP standards.
Because of its closed-system design, NANT001 can be hosted in Grade D manufacturing suites as the risks of cross-contamination and loss of sterility are minimized. Because of automation, both the number of operator interventions and processing time are also reduced compared to traditional expansion methods, allowing for process robustness, standardization and overall improvement of manufacturing costs.
Moreover, information from the integrated in-process control monitoring as well as operator ID and interventions are collected to generate a final run report supporting complete traceability.
Osteoarthritis therapy is already available in dogs
To date, 120+ dogs have been treated with outstanding and long-lasting results.
Our PAWER therapy is easy and safe and only requires the collection of a small amount of adipose tissue. We extract, select and amplify stem cells which are then reimplanted into the articulation.
CAREERS
VivaBioCell S.p.A. is always looking for talented, enthusiastic and motivated people to join our teams. Please send your CV for spontaneous candidature at segreteria@vivabiocell.it or look at our current vacancies page to find more about open positions.
POR FESR 2014-2020 FVG: OPPORTUNITA' PER UNA CRESCITA SOSTENIBILE
SISICOR: nuovo Sistema Implantare per la Stabilità immediata di impianto in Chirurgia Orale di Ricostruzione
Contributo finanziato € 252.856,15 (DGR n. 849/2016. Pratica n. 24140/2016)
Data di avvio: 01 Febbraio 2017. Data prevista di conclusione: 31 Maggio 2018.