2020-09-22
First foreign Company to join the Swedish ATMP network
The CAMP project ”GMP-compliant infrastructure and production in a hospital-setting of mesenchymal stromal cells from lipoaspirate for use in clinical trials” welcomes Italian company VivaBioCell. VivaBioCell is the first company in the Swedish ATMP network that does not have a Swedish subsidiary.
“We are very happy to welcome VivaBioCell as a new CAMP partner, in what is a milestone as the first foreign company to join our centre. VivaBioCell’s industrial expertize on automated solutions for manufacturing of ATMPs is a valuable addition to the growing partnership of CAMP and we look forward to a productive collaboration”, says Centre Director Jukka Lausmaa.
While minimally manipulated cells are processed and transplanted in hospital settings as standard care for many conditions (eg. blood transplant), when cells are to be used for non-homologous functions and/or substantially manipulated eg. cell expansion, the processing must occur in a cGMP-compliant fashion. Through their CAMP project, the team at Örebro University Hospital aim to automate the production of MSCs from lipoaspirate. There are multiple reasons for this including the removal of manual handling of cells, which minimizes potential for human errors and provides greater control and thus standardization of the process for greater reproducibility.
VivaBioCell has 2 bioreactors of interest to this project, the NANT 001 and NANT XL. Both systems work based on manual cell culture principles, culturing adherent cells in flasks with the ability to observe cells during culture and to harvest, all in a closed GMP compliant environment. These bioreactors can produce small-scale cell therapy products at a low cost, with full traceability and continuous monitoring of in-process controls parameters. The closed nature of the system minimizes infection risk, compared to manual handling, and gives the opportunity of running the systems in a clean room class D. In terms of capacity the NANT 001 has a maximum growth area of 636 square centimeters and the NANT XL gives the option to expand cells from an initial seeded culture flask to a final growth area of 3180 square centimeters.
With a future where cellular therapies, both homologous or non-homologous are set to explode, systems for handling cells in a safe, standardized and cost-efficient way are going to be critically important to the breadth of availability of treatments. Reducing manual handling not only reduces the training requirements for staff but automation reduces staff hours to be present during the process. The VivaBioCell bioreactors can be programmed start to finish to plate the cells, feed them, wash them, rock them, image them and harvest them. The system can even estimate cell confluency from acquired images. The user can follow the progress, monitor critical parameters (temperature, CO2) even see the cells, on the associated mobile phone app while they go about their work or while they are enjoying their weekend activities, in place of coming to the lab to change media.
VivaBioCell was established in 2007, as a spin-off of the Udine University, Italy. Their mission is to provide smart and cost-effective solutions that allow for the improvement and standardization of advanced therapies manufacturing. VivaBioCell also brings with it experience in the application of expanded lipoaspirate MSCs for Osteoarthritis treatment, a possible application for the Örebro University Hospital grown cells.
More information can be found here: http://www.vivabiocell.it/about/
With interest to join one of our CAMP projects contact us!