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: http://intervacc.se/en/validation-batches-of-strangvac-completed/
About 3P Biopharmaceuticals
3P Biopharmaceuticals is a leading CDMO specialized in process development and GMP manufacturing of biologics and cell therapy products. 3P offers solutions at all stages of biologics development, from the initial process and analytics development to preclinical and clinical phases and commercial production. Its extensive experience, flexibility, and adaptation, as well as its innovative technology and qualified team, have made 3P an example for the international market.
For further information: http://www.3pbio.com/
Intervacc AB (publ) is a company within the Biotechnology sector. The Company´s main area is to develop modern sub-unit vaccines against economically important bacterial infections, within animal health. The company´s vaccine candidates are based on several years of research at Karolinska Institutet and the Swedish University of Agricultural Research where the foundation was laid for the company´s research and development work. The Intervacc share has been listed on the NASDAQ First North Growth Market since April 2017 with Eminova Fondkommission AB, email@example.com, +46 (0)8–684 211 10 as Certified Adviser.
For further information: http://intervacc.se/en/
LIOF-Pharma (previously Praxis Pharmaceutical) is a European CDMO specialized in Drug Delivery, Formulation and ASEPTIC FILL FINISH, including LYOPHILIZATION of Biologics (proteins, Abs, etc.) and small molecules for clinical manufacturing and small/medium scale commercial manufacturing. Their brand new aseptic filling line can be considered as one of the best choices for small/medium size batches based on its superior process safety and flexibility, especially appropriate for high-value products.
Strangvac®, a modern vaccine against Strangles, a highly contagious and serious infection in horses caused by the bacterium Streptococcus equi. Strangvac® consists of only soluble recombinant proteins is injected intramuscularly and totally devoid of any living infectious agent. This results in a well-tolerated vaccine with an excellent safety profile, as expected of a modern vaccine.