3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in the process development and GMP manufacturing of biologics has, together with the Swedish biotechnology company Intervacc AB and LIOF-Pharma (previously Praxis Pharmaceutical), completed the manufacturing process for the vaccine against equine strangles called Strangvac.

The validation production batches required for the forthcoming registration application to the European Medicines Agency, EMA, are 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, 3P Biopharmaceuticals.
 
Andreas Andersson, chief executive officer, Intervacc, said, “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.”
 
According to 3P, 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.