GLP bioanalysis compliant with ICH-Q6B for biological products, as well as pharmacokinetics, DMPK, and bioanalysis services for chemical drugs.
1. GLP bioanalysis services compliant with ICH-Q6B for biological products: recombinant proteins, monoclonal antibodies, antibody-drug conjugates (ADCs), vaccines, peptides, glycoproteins. 2. Pharmacokinetics, DMPK, and bioanalysis services for chemical drugs: We provide biological testing services at all stages of drug development, including preclinical, clinical, and post-marketing, not only for biopharmaceuticals but also for small molecule drugs.
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basic information
1. GLP bioanalysis services compliant with ICH-Q6B for biological products - Analytical methods Molecular weight and amino acid sequence Glycan structure and profiling Disulfide bridges Peptide mapping - Equivalence/homogeneity and biosimilarity evaluation - Pharmacokinetic testing (LS-MS, ELISA) - Impurities derived from the process or the target substance (purity measurement, cleavage products, post-translational modifications (PTM), host cell-derived proteins) - Discovery and validation of biomarkers - Proteomics analysis - Method development 2. Pharmacokinetics, DMPK, and bioanalysis services for chemical drugs - Biological equivalence and bioavailability - PK testing in preclinical and clinical trials - Development and validation of bioanalytical methods such as LC-MS/MS, UPLC-MS, ICP-MS, ELISA - In vitro metabolism testing - Pharmacokinetics - Bridging study evaluation
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Company information
Libra Medicina Co., Ltd. aims to contribute to the improvement of health and quality of life for people around the world by being involved in the creation of innovative pharmaceuticals and medical devices through development support services and licensing activities, delivering hope to patients suffering from serious diseases.