Protagen AG has been awarded Good Manufacturing Practice (GMP) certification and has announced that it will be providing customers with protein analysis services in accordance with the international quality assurance guidelines with immediate effect.
Protagen is one of the first biotechnology companies in Germany to meet the requirements for approval from the USA Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) to offer analytical methods within the guidelines for manufacturers of therapeutic proteins.
Commenting on the announcement, Christoph Huels, CEO of Protagen said: "Being awarded GMP certification is a great achievement for Protagen and underlines our strategy to provide protein analysis services of the highest quality. We are committed to supporting our customers in their effort to meet the industry's increasingly strict controls and regulations, and we are delighted to be able to offer the flexibility of tailoring research programmes and providing protein services under GMP where required."
Protagen became certified for protein analysis under GMP in May 2006. Since that time, the Company’s GMP-compliant protein analysis services have been tested with numerous reference customers.
Protagen has recently completed a programme of work under GMP for Nordmark Pharma, Hamburg and will now introduce the GMP services to a wider circle of pharmaceutical customers.