Live virus vaccines:
at the heart of Naobios’ experience
Live virus vaccines are derived from “wild-type viruses”. These wild-type viruses are attenuated, usually by repeated culturing. An attenuated vaccine has a reduced virulence of a pathogen, but still keeping it viable or “live”. These vaccines contrast to those produced by “killing” the virus (inactivated viruses), also manufactured at Naobios.
Live attenuated vaccines are produced by growing the virus in culture. The virus is then purified using state of the art chromatographic processes.
Naobios’ experience with live viral vaccines encompasses diseases like Measles, Rubella, HIV, SARS-CoV2, Poliovirus, Rubella, Vaccinia and Influenza (non exhausted list).
We operate under the scope of our EU GMP license while maximizing the use of single-use systems.
Process Development capabilites
The team is able to undertake projects from the initial production of starting material to final GMP drug substance manufacturing, including cell and virus banking.
With our four independent BSL2 and BSL3 manufacturing suites from Grade D to Grade B, we are able to manage aseptic or non-aseptic processes and we accommodate the necessary processes and the technologies to meet the client’s requirements.
Purification is performed using scalable chromatographic processes and other downstream unit operations as Filtration processes from dead end Filtration for clarification and sterile filtration when possible to TFF (Tangential Flow Filtration).
Quality Control testing
Naobios performs the full characterization and release of manufactured products according to international guidelines and is able to propose the development and validation of bespoke assays for the specific evaluation of your live vaccine product.
Support for this activity is provided by sister company Clean Cells.
Naobios can offer Fill & Finish activities allowing an end-to-end solution to our partners from process development to Drug Product manufacturing.
Aseptic Drug Product filling for clinical batches is performed according EU GMP requirements and in compliance with updated EU GMP Annex 1.