Large-scale manufacturing process for Strangvac now secured
The biotechnology company Intervacc has together with 3P Biopharmaceuticals, the contracted manufacturer of Strangvac, 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.
For more information please contact:
Jan-Ingmar Flock, CSO - Chief Scientific Officer,
E-mail: firstname.lastname@example.org, Phone: +46-8-120 10 602
Tim Wood, director CMC & Regulatory,
E-mail: email@example.com, Phone: +46-8-120 10 608
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 April 1, 2019.
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 Institutet and Swedish University of Agricultural Research where the foundation was laid for thecompany´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.
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.
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. http://www.3pbio.com/