Biopharmaceuticals, particularly biological analysis services for ADCs.
We provide bioanalytical testing services for biopharmaceuticals and small molecules, capable of meeting needs at various stages of development. We specialize in pharmacokinetic analysis of biopharmaceuticals and possess advanced techniques, such as simultaneous analysis of the pharmacokinetics of the antibody portion and the payload portion. Our company offers a comprehensive CRO service, including the planning of biological tests in accordance with ICH Q6B, supporting drug development broadly from exploratory research to application, manufacturing, and clinical trials. For more details, please contact us or download our catalog.
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basic information
【Overview】 〔LC-MS-based analysis for drug development〕 mAb, ADC, peptides, glycoproteins, recombinant proteins, vaccines ・Determination of full amino acid sequences ・Equivalence testing for biosimilars ・Identification of impurities ・QC release testing ・Production optimization ・Stability testing 〔GLP bioanalysis based on ICH Q6B〕 ・Biochemical characteristics Molecular weight, size / amino acid sequence / terminal sequence Peptide mapping / S-S bonds / glycan structure ・Impurities related to the production process and products Truncated forms / post-translational modifications / host cell-derived proteins 〔Customization of testing method development〕 ・ELISA assays ・Bioavailability (BA) / bioequivalence (BE) / pharmacokinetics (PK) testing ・Discovery and validation of biomarkers, etc. ● For more details, please contact us or download the catalog.
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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.