After being inspected by the Swedish Medical Products Agency, and a major group of current Clients, the new facilities, located within the new Science Village area in the city of Lund, have been approved and certified according to the European Good Manufacturing Practice standards.
Hussein Ismail (CEO): “two years of planning this step is now getting to its end. Our new site is custom designed for its purpose and will increase the current storage capacity by at least five times. In addition, new logistic services will be introduced”.
Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP. This includes handling operations such as storage and transport. The new site will be able to host large scale batches of intermediate products, as well as wholesale production batches.
“Birka BioStorage´s new site will be the biggest shared depot of samples in Europe. We are currently undergoing the Good Distribution Practice (GDP) certification process as well, which will be in place within the nearest future. This will add the opportunity to distribute Clients IMPs directly to clinical trials”, says Hussein Ismail (CEO).
The 30 million SEK new site has been purpose made to become a strategic logistic partner during the process of developing new pharmaceuticals. The site has been constructed by Björnstorps Gods AB and equipped by the company´s main investor Ebba Fischer.
