PANATecs GmbH, Heilbronn, has concentrated on protein analysis with mass spectrometry, as well as protein synthesis. The company is certificated according to ISO 9001 and GMP. Since March 2010, PANATecs has had manufacturing authorization for test laboratories, in accordance with § 13 of the 15th Amendment of the Pharmaceuticals Law.
PANATecs is a service provider to pharmaceutical, diagnostic testing and biotechnology companies. The procedures we use provide detailed and reliable data for biotechnological product and process development, as well as for quality assurance and batch release. We also provide advice on all aspects of protein analysis, develop individual analytical procedures and validate them in accordance with the international set of rules of the ICH and EU guidelines. Thus PANATecs provides its customers with a differentiated portfolio of services – adapted to the needs of the industry. This covers many aspects of decisive importance in the development, manufacture and approval of biologicals, biosimilars and diagnostic testing kits.
PANATecs offers solutions to a variety of important problems related to protein analysis by mass spectrometry, especially for the pharmaceutical and biotechnology industries. This includes the characterization in accordance with ICH of recombinant proteins, such as glycoproteins and antibody products.
• Clarification of post-translational modification, such as methione oxidation and asparagine deamidation
• Direct analysis of protein complexes using MALDI High Mass Technology
• Identification and quantification of host cell proteins
• Absolute mass spectrometric quantification of proteins
• Quantitative amino acid analysis (qASA)
• P-CHECK for the reliable detection of protease contamination in protein-based raw materials
and biotechnologically manufactured raw materials (APIs)
• GMP-certificated protein analysis
• Synthesis and quality control of peptides