Investigational product manufacturing
Investigational Product Manufacturing: an expert team for your virus-based biologics
Naobios is a GMP-certified company with a vast experience in manufacturing of preclinical and clinical lots of viral vaccines (live or inactivated), viral vectors and oncolytic viruses.
We deliver batches for clinical programs up to Phase III on scalable processes for commercial manufacturing and we provide full support to your projects from upstream and downstream process development to final Drug Product, including associated quality control testing.
An extensive track record
We offer adherent or suspension cell-based processes and gathered a wide experience with growing adherent cells on microcarriers.
Our trained team has manufactured numerous Investigational Medicinal Products (or IMPs) including substances based on Rubella, Hepatitis A, Influenza, MVA (modified Vaccinia Ankara), various strains of Measles, New castle Virus (NDV), Sindbis and Poliovirus.
We can produce under aseptic or non-aseptic conditions for the processes which consist in cell growth, virus production, purification and inactivation if needed.
To anticipate commercial phase costs, we can bring our support to customers on process economics with cost of good analysis.
The manufacture of sterile investigational products according to EU GMP guidelines (and particularly Annex 1 of Volume 4) requires that some key operations be carried out aseptically specially for large therapeutic molecules like viruses where a final sterile filtration is not possible. Aseptic process validation is then required for those steps where a simulation of the process (APS) will be performed, such as:
- Aseptic Process Simulation of Drug Product filling (for small batches)
- Aseptic Process Simulation of specific part of process
High quality equipment and facility for the manufacture of IMPs
Our facility consists of four independent BSL2 to BSL3 manufacturing suites from grade D to grade B allowing production under aseptic conditions and where we can work with volumes up to 250L.
We use single use systems extensively throughout processing which provide scalable platforms essential to take processes from early clinical phases into commercial while avoiding cross contaminations and thus optimizing our multipurpose facility.
We use a broad range of technologies for suspension and adherent cell lines:
- Single use bioreactors up to 250L, both stirred tank single use bioreactors and fixed bed bioreactor up to 500m²,
- Purification using single use chromatography system (AKTA ready™)
- Inactivation performed in virus-free area
- Filling of small DP batch with semi-automatic process
A dedicated area for In-house manufacturing of media and solutions further adds to our versatility.
Complete QC support
Investigational Product manufacturing is supported by an in-house quality control team who manages the testing of your batches including all critical in process control requirements.
We work with our sister company Clean Cells to perform some release testing of cell banks, virus seeds, harvests or lots of medicinal products.
We are able to deliver QP certification of drug product lots.