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3P Bio, Intervacc Secure Large-Scale Mfg. Process

Tech transfer and scale-up of the mfg. process with verification of reproducibility for Strangvac production has been completed

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By: Tim Wright

Editor-in-Chief, Contract Pharma

3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in the process development and GMP manufacturing of biologics, and the Swedish biotechnology company Intervacc AB, have secured the large-scale production of the vaccine against equine strangles called Strangvac. The technology transfer and scale-up of the manufacturing process with verification of reproducibility for Strangvac production has been completed. Intervacc intends to submit a registration application for Strangvac at the end of 2019. In order to accomplish this goal, large-scale commercial batches will be manufactured in compliance with GMP.
 
The commercial manufacturing of the vaccine, which is based on recombinant proteins, will be done in accordance with the protocol for large-scale production that has now been established. The scale-up process has given a very good yield and purity of the components, which has a positive impact on production cost and the product’s quality.
 
“It is a great satisfaction to achieve this manufacturing process phase after an important development for that vaccine,” said Dámaso Molero, general manager, 3P Biopharmaceuticals.
 
Jan-Ingmar Flock, chief science officer, Intervacc AB, said, “An important preparatory step has now been completed for the upcoming commercial large-scale production in compliance with GMP. This, in combination with the recent pre-submission meeting with the European Medicines Agency (EMA), confirms the previously established timetable for Strangvac.”
 
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.

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