Validation batches of the vaccine against equine strangles Strangvac® is completed

3P Biopharmaceuticals, a leading 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 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.

Original source:

Related Content

3P Biopharmaceuticals reinforces its commitment to female talent with its participation in the programme ‘Lidera en femenino-STEM’

The Head of Quality Assurance & Qualified Person at 3P Biopharmaceuticals, Susana Santesteban, has attended ‘Lidera en femenino-STEM’, a course that aims to help promote the career advancement of STEM women.
Read more

3P Biopharmaceuticals and Buzzard Pharmaceuticals start a collaboration to develop a new treatment to combat solid tumours

3P Biopharmaceuticals and Buzzard Pharmaceuticals have entered into a partnership agreement for manufacturing of the potent IL-1 inhibitor Isunakinra, a recombinant protein for cancer indications.
Read more

Working in biotechnology means working to improve the planet and people’s lives

Ion Arocena, CEO of AseBio, has delivered a speech at an event organised as part of the agreement that 3P Biopharmaceuticals has signed with the School of Pharmacy and Nutrition of the University of Navarra to promote training in Biotechnology
Read more

Get in touch

Let’s discuss your biologics journey.

Discover more about our people, our passion, and how we can work together to improve lives.