Oncolytic virus and ATMPs
Oncolytic viruses and ATMPs: cutting-edge medicines manufactured with advanced equipments
The manufacture of oncolytic viruses and ATMPs (and in particular gene therapies and cell-based therapies) require state-of-the-art technologies and increased technical knowledge.
Our experience handling live and inactivated vaccines has served as a steppingstone to the production of other virus-based medicines which harness their power to develop innovative treatments.
Our CDMO services fully cover sponsors’ needs and include development and optimization of processes (upstream and downstream), GMP manufacture, analytical development and GMP quality control testing.
We are helped with QC testing by our sister company Clean Cells which has worked with dozens of cell and gene therapies and has developed specific tests for the characterization of ATMPs, including karyology-based and replication competent tests.
The production of oncolytic viruses
Oncolytic virotherapy uses oncolytic viruses, wild or genetically modified, as antitumor agents using their strong and highly restricted cytolytic effect towards transformed cells together with bespoke strategies to increase antitumor efficacy and safety.
Some wild viruses have natural oncolytic activity in human tumors, as New Castle Disease virus (NDV) while other viruses require genetic modification to achieve an oncolytic activity.
Similar to virus amplification for virus-based vaccines, oncolytic viruses for cancer treatments are produced by expanding the viruses in cells and then by purifying them using suitable downstream purification trains commonly using chromatographic and filtration-based processes.
Oncolytic viruses can be used either as a monotherapy or combined with existing checkpoint inhibitors/T cell therapies to provide an enhanced therapeutic response.
Naobios’s know-how in manufacturing oncolytic viruses revolves around New Castle Disease Virus (NDV), Sindbis Virus and Modified Vaccinia Viruses (MVA).
The production of cell and gene therapies
With the experience accumulated by the team for more than 15 years, we at Naobios perceive the development and manufacturing of ATMPs as a natural extension of our capabilities. It is thus our goal to expand activities in this field, covering viral vector production for gene therapy or other cell derived material for use as cell therapies sustained by our strict segregation policies and cleaning procedures.
Naobios’s experience with viral vectors typically used for Gene therapy spans Poxvirus and MVA (Modified Vaccinia Ankara).