The validation production batches required for the forthcoming registration application to the European Medicines Agency, EMA, are thus finalized.
Submission of a registration application requires manufacturing of two batches in a scale that will be used for commercial production. The drug substance (antigens) for these batches have been produced during the summer and have been included as active components in the vaccine doses that now have been finalized. In total, 60.000 vials with vaccine doses have been manufactured and released.
“We are proud to go ahead successfully with Strangvac and the validation batches for the EMA’s application means that we are one step closer to achieve the approval for that vaccine,” said Dámaso Molero, General Manager at 3P Biopharmaceuticals. “The documentation on these two commercial batches is part of the dossier that we will submit to the European Medicines Agency (EMA).Now that we have manufactured the vaccine on a commercial scale that meets our specifications, we have passed another very important milestone towards an approved vaccine against strangles” says Andreas Andersson, CEO of Intervacc. Also, Tim Wood, VP CMC and Regulatory at Intervacc, who has worked intensively with the project, says: “We are very pleased with a robust, reliable and efficient manufacturing process.”
The vaccine has been developed with a technology based on recombinant proteins that reduces the risk of serious side effects, which is a key characteristic in the new generation of vaccines based on that technique.