The Swedish-based biotechnology company Intervacc, has, together with 3P Biopharmaceuticals, the contracted manufacturer of Strangvac in Barcelona, Spain, secured large-scale production of the vaccine against equine strangles. The technology transfer of manufacturing and the verification of reproducibility of the manufacturing process for Strangvac has thereby been completed.
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 in the vaccine, which has a positive impact on production cost and the product's quality.
“We are very pleased to be able to give this message when we are in an intensive phase in the development of the commercial production process,” says Andreas Andersson, CEO of Intervacc.
“An important preparatory step has now been completed for the upcoming commercial large-scale production in compliance with GMP [Good Manufacturing Practice]. This, in combination with the recent pre-submission meeting with the European Medicines Agency (EMA), confirms the previously established timetable for Strangvac,” says Jan-Ingmar Flock, CSO of Intervacc.
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 and to do this, two large-scale commercial batches in compliance with GMP must be manufactured. 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.
Read more at Intervacc.
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