3P Biopharmaceuticals and Intervacc secure the large-scale manufacturing process for Strangvac®
[Noáin, May 6, 2019] 3P Biopharmaceuticals, a leading 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. In fact, Intervacc AB intends to submit now 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 at 3P Biopharmaceuticals. Besides, Jan-Ingmar Flock, CSO of Intervacc AB adds that “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.
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, mainly within animal health. The company´s vaccine candidates are based on several years of research at Karolinska Institute 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 market since April 2017 with Eminova Fondkommission AB as Certified Adviser.
For further information: http://intervacc.se/en/
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 for analytics development, preclinical and clinical material supply, commercial production. 3P is well known for its extensive experience, flexibility, and a team of professionals.
3P has the support of an important group of investors: Cinfa Group. Cinfa Group is a holding of companies that handles different business lines in the world of health, with more than 50 years of experience and expertise in the biotech and pharma market. It's flagship company, Laboratorios Cinfa, is a successful manufacturer that ranks first in terms of generics´ retail in Spanish pharmacies. For further information: http://www.3pbio.com/