Our experience: diverse equipments for adherent and suspension cell-based processes
Mainly using single-use systems, Naobios specializes in the manufacture of virus vaccines and viral vectors, at a preclinical stage and at a clinical step under our EU-GMP certificate.
We have over 15 years of experience developing and producing both live attenuated vaccines and inactivated vaccines and our capabilities extend to other viral vector production schemes including those used for gene therapies and oncolytic viruses for cancer treatment.
Naobios has substantial experience handling various types of cells.
We can propose different technologies for adherent cell-based processes using, for example, micro-carriers, fixed bed reactors or roller bottles where we have worked with MRC5, Vero, BHK21 and CEF.
We can also work with processes based on suspension cell lines as demonstrated by our past projects with CAP, EB66 or CHO cells for example.
The team has developed and used several processes using a large number of viruses, either wild or genetically modified such as various strains of Measles (including recombinant versions), Rubella, hepatitis A, influenza, MVA (modified vaccinia Ankara), NDV (Newcastle Disease Virus) and Sindbis.
Production scale and technologies
Naobios is able to produce at a small scale for process development or early phase development while benefiting from capacities for initial phases of clinical trial studies, where we can scale up a process from laboratory scale to 200L scale.
We can hence accommodate vaccine production for preclinical and clinical studies up to Phase III, depending on technical specifications.
Naobios performs manufacturing under EU-GMP and broadly uses single-use systems limiting the cleaning validations.
With our two class B areas, we are able to manage aseptic processes, and are also able to accommodate 3 to 4 projects simultaneously.
Some examples of processes
- Growing Vero cells on microcarriers: more than 60 USP runs at 2L scale and 50 runs in SUB at 20L scale
- Growing MRC5 cells in Cell Stacks and Roller Bottles
- Experience with the iCELLis system (nano scale, iCELLis 500+) under GMP
- Technology transfer (including process and analytical methods for release): 3 x process transfers in, 2 x process transfers out
- Aseptic and non-aseptic processes