Lipotype: The First and Only Shotgun Lipidomics Service Provider with Official GMP Certification Worldwide

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 the first and only shotgun lipidomics service provider with official GMP certificate by state authority worldwide, 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 was certified by the federal authority of Saxony (Landesdirektion Sachsen) for lipid determination by mass spectrometry on the 26 February 2019.

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