Swedish pharmaceutical plant grants production permit from Medical Products Agency
Swedish pharmaceutical plant grants production permit from Medical Products Agency The newly founded biotech and pharmaceutical company ArctiCon BioPharm Production AB in Luleå, has after its first inspection from the Swedish Medical Products Agency, received an advance ruling regarding a production permit. The production permit means that Medical Products Agency has approved ArctiCon to perform biological and pharmaceutical production for clinical trials. Thus ArctiCon can offer contract manufacturing or perform its own production, such as cell culture and purification of bio proteins, e.g. manufacturing of active pharmaceuticals substances under strict GMP rules. -As closer these newly founded biotech companies get to commercialisation, we perceived very early on the increased demand for manufacturers compliant with the Food & Drug Administration (FDA) and Medical Products Agency's regulations in connection with production for clinical trials, says Torgny Lundgren, CEO of ArctiCon BioPharm Production AB. -At ArctiCon we have more than 15 years of experience of biotechnology and cell culture activities, development of recombinant proteins (antibodies) and have participated in several FDA inspections with approvals. We are convinced that our Business Idea to firstly provide competence and laboratories for product development services and cell culture to produce biological drugs to be used for instance in cancer treatment and secondly to offer external customers contract production of drugs and vaccines, makes us a very competent and reliable partner. The company has today 10 employees and are growing rapidly, finalises Torgny Lundgren. -Contract manufacturing and production of biological drugs has an enormous potential and the market is growing annually with 25-30 %. Only in Sweden more than a 100 bio-tech companies were started during 2001, which many of those might be in need of the services and experiences that ArctiCon can provide, says Claes-Göran Fridh, CEO of Affärsstrategerna AB. Affärsstrategerna owns 21% of ArctiCon BioPharm Production AB, whereas 5% is reserved for a call options programme to the employees of ArctiCon. For further information please contact: Torgny Lundgren, CEO, ArctiCon, phone +46 920 211 887 or e-mail: torgny@arcticon.se Yvonne Petersson, Business Developer, Affärsstrategerna Phone +46 8 545 831 92 or e-mail: yvonne@astrateg.se Claes-Göran Fridh, CEO, Affärsstrategerna, phone +46 8 545 831 95 or e-mail: cgfridh@astrateg.se. Affärsstrategerna is a leading seed investment venture capital company listed on the OM Stockholm Stock Exchange O-list. Affärsstrategerna invests value-added capital in innovative start-ups, operating in IT/Internet, Wireless and Life Science/Medical Technology, and has the potential to become market leader in its niche. Some of the companies in the portfolio are: Alpha Helix, aPROch, Arcticon Biopharm, A3TL, Cartesia, Chemel, Fingerprint Cards, FreeHand DSP, InfiniCom, M-Phone, Musicbrigade, Naty, Netbaby World, Optilink, Picron Microarrays, RaySearch Laboratories, RSC Technology, Samba Sensors, Sonesta, Strand Interconnect, SWATS, Webupdate, Widermind and Wireless Assets, Inc ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/03/04/20020304BIT00940/wkr0001.doc http://www.waymaker.net/bitonline/2002/03/04/20020304BIT00940/wkr0002.pdf