The biotechnology company Intervacc has together with 3P Biopharmaceuticals, the contracted manufacturer of Strangvac, finalized the production of the drug substances on a commercial scale in compliance with GMP (Good Manufacturing Practice).
“We are very pleased to announce that we have now manufactured the drug substances for several million doses of Strangvac, the new vaccine against equine strangles“ says Andreas Andersson, CEO Intervacc AB
“An important preparatory step has now been completed for the final completion of validation batches needed for submission of a registration application to the European Medicines Agency (EMA). This confirms the previously established timetable for Strangvac and that the process for large-scale manufacturing works well” says Jan-Ingmar Flock, Chief Scientific Officer at Intervacc.
The final steps in the manufacturing process for Strangvac are done in collaboration with Praxis Pharmaceuticals in Spain that provide final formulation, filling of vials and packaging of finished product.
Strangvac has undergone clinical trials and safety tests with good results. Intervacc intends to submit a registration application for Strangvac at the end of 2019.
To do this, two large-scale commercial batches in compliance with GMP must be manufactured, where the drug substances now have been manufactured at a level sufficient for several million doses, in addition to the validation batches required for the application.
The vaccine has been developed with a technology based on recombinant proteins instead of killed or attenuated micro-organisms, which is found in conventional vaccines. This reduces the risk of serious side effects – one of several good characteristics in a new generation of vaccines based on recombinant proteins.
Original source: Intervacc