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Innovations in cell and virus banking
As part of Contract Development and Manufacturing activities, Clean Cells has been involved in dozens of GMP cell and virus banking projects for sponsors around the world. The banks have since been used for the manufacture of all types of biological products ranging from vaccines to gene therapies.
Our expert team has gathered considerable data on hundreds of mammalian and non-mammalian substrates and countless virus strains and works to make sure that initial seeds yield the best results while bringing expansion processes to GMP as promptly as possible. Our QC department ensures full release and characterization of the banks according to the latest European (Ph.Eur.), US (USP, PTC, FDA) and ICH guidelines. The banks can then enter our secure room within our GMP environment for long-term storage.
Our Manufacturing team also brings innovation to the banking processes. Here are a few of our most recent projects involving new technologies and material:
Spinner bottle-based production of Quail cell banks
As opposed to typical flasks or bottles used in incubators, spinner bottles have a built-in stirring system that allows for optimized cell cultivation processes through individualized programming of culture parameters.
This equipment has been successfully implemented at Clean Cells for the manufacture of innovative Quail fibroblasts (highly permissive to viruses) to circumvent the use of Chicken Embryo Fibroblasts (CEF) for vaccine production.
Clean Cells’ extensive GMP QC capabilities for avian-based material testing ensures safety at each stage of manufacturing.
CHO cell banking in wave bioreactors
Chinese Hamster Ovary cells (CHO) are probably the most renowned cell type in biomanufacturing. Adaptation to suspension cell culture brings the cell line to high density, making it material of choice for recombinant protein expression.
CHO manufacturing in wave bioreactors is optimizing suspension cell culture beyond flask-based protocols.
The wave bioreactors are equipped with disposable bags and provide unique rocking parameters that makes cultivation and scaling-up steps easier and safer, while ensuring reproducibility through advanced automation. Higher titres may also be achieved with this technology and culture parameters can be monitored even more closely with built-in sensors.
SARS-COV-2 expressing virus banking and testing
Clean Cells is at the forefront of the fight against COVID-19 along with our sponsors. As soon as June 2020, our analytical department had already developed a qPCR-based assay for the detection of SARS-COV-2 according to WHO guidelines.
We are taking a step further by taking part in the production of a vaccine. Clean Cells will generate virus banks from a modified virus expressing SARS-COV-2 epitopes further used to expand the virus and generate vaccine lots.
Clean Cells will also provide its extensive analytical portfolio and considerable expertise in QC testing to ensure the complete characterization of the manufactured virus seed stocks.
News - December 2020
Save the date ! New webinaire on January 14,2021 !
GMP biosafety testing of gene therapy products – the case of the detection of replicative-competent lentiviral particles in lentiviral vector preparations
Our newest addition to our webinar series will address the matter of GMP biosafety testing of gene therapy products. Join Dr Xavier Leclerc on 14 JAN 2020 to discover how Clean Cells provides solutions for gene therapies in a talk focusing on the detection of replicative lentiviral particles.
BSL3 manufacturing area
Naobios opens a new BioSafety Level 3 manufacturing unit
Naobios is pleased to announce the opening of a new 110m2 BL3 manufacturing area, following major revamping of the facility.