Nuvalore

A GMP analytical contract laboratory in Leimen, Germany, nuvalore holds EU GMP certificates and manufacturing authorisations for quality control testing of human and veterinary medicinal products, issued by the Regierungspräsidium Tübingen. Method development, validation and transfer are handled under both conventional and Analytical Quality by Design approaches, concentrating on quality control methods for stability testing of parenteral and oral medicinal products. The routine portfolio covers compendial analysis to Ph. Eur. and USP, identification and characterisation methods, protein and surfactant characterisation, and testing of primary packaging materials and application systems. Antibody-drug conjugates are a named specialism, with drug-to-antibody ratio analysis, charge variant analysis, peptide mapping and impurity profiling combined orthogonally across chromatographic, electrophoretic and mass spectrometry techniques. Therapeutic peptides are treated as a separate modality.