The manufacturing process for Strangvac is proceeding according to plan
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.
For more information please contact:
Andreas Andersson, CEO
E-mail: andreas.andersson@intervacc.com, Phone: +46-8-120 10 601
or
Jan-Ingmar Flock, CSO – Chief Scientific Officer,
E-mail: jan-ingmar.flock@intervacc.com, Phone: +46-8-120 10 602
This information is information that Intervacc AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on August 7, 2019.
About Intervacc
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 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 market since April 2017 with Eminova Fondkommission AB, info@eminova.se, +46 (0)8–684 211 00 as Certified Adviser.
About 3P Biopharmaceuticals
3P Biopharmaceuticals is a leading CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products. 3P offers its customers solutions for all stages of biologics development: process as well as analytics development, preclinical and clinical material supply, commercial production. 3P is well known for its extensive experience, flexibility and team of professionals. http://www.3pbio.com/
About Praxis Pharmaceutical
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. http://www.grupo-praxis.com/es/
About Strangvac®
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 excellent safety profile, as expected of a modern vaccine. Intervacc plans to submit the dossier for Strangvac® to the European Medicines Agency by the end of 2019.
Contact information for Certified Adviser
Eminova Fondkommission AB
E-mail: info@eminova.se, Phone: +46 (0)8 – 684 211 00
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