Good Manufacturing Practices (GMP) ensure safety and quality of pharmaceutical products. Lipotype is the worldwide first and only officially GMP certified shotgun lipidomics service provider for pharmaceutical applications.
Quality variations can pose direct threats to patient health – especially in the pharma industry. This is why quality control plays a central role in manufacturing and developing pharmaceutical products. GMP certifications are issued by governmental authorities to ensure product quality and compliance with mandatory health agency requirements.
As worldwide first and only shotgun lipidomics service provider with official GMP certificate by state authority, Lipotype now offers untargeted, global and absolutely quantitative lipidomics analysis services according to GMP regulation laid down in Directive 2003/94/EC.
Pharma researchers challenging therapeutic limitations by developing new pharmaceutical products can draw on Lipotype Shotgun Lipidomics services beyond lipidomic analysis of content, purity and stability. Development of GMP compliant analytical tests and release analysis of compounds from clinical trials to market release complete the portfolio of GMP certified lipid analysis services.
In Germany, GMP certificates are issued by the competent authorities based upon an evaluation of compliance with mandatory and/or non-mandatory applicable legal requirements intended to ensure product quality and safety. Lipotype has been certified by the federal authority of Saxony (Landesdirektion Sachsen) for lipid determination by mass spectrometry on the 26 February 2019.
Lipotype delivers comprehensive, absolutely quantitative lipid analysis services for clinical and biological samples on a high-throughput scale. Drawing on many years of cutting edge research experience, Lipotype offers high quality lipid analysis services for a wide range of customers and applications including biomarker identification for clinical researchers, pharma and biotech companies, functional food development for the food industry, claim support for the cosmetics industry, as well as for the small-scale profiling needs of academic researchers.
Lipotype is a spin-off company from the Kai Simons and Andrej Shevchenko labs of the world-renowned Max-Planck-Institute of Molecular Cell Biology and Genetics in Dresden, Germany. www.lipotype.com
T: +49 35179653-45