Biopharmaceutical analysis

Supports characteristics analysis and equivalence evaluation between lots! We assist customers in biopharmaceutical development.

At Spela Pharma, we have recently developed analytical capabilities related to the rapidly growing field of biopharmaceuticals. In "Setting Quality Testing Methods and Stability Testing for Biopharmaceuticals," we develop and establish analytical methods for the quality evaluation of biopharmaceuticals, primarily focusing on antibody drugs, conduct method validation, and perform shipping tests for clinical trial drugs. We are also capable of conducting stability tests to ensure the stability of biopharmaceuticals. In "Characterization and Equivalence Evaluation of Biopharmaceuticals," we select and evaluate appropriate analytical systems to support our clients' biopharmaceutical development. 【Main Analytical Functions (Partial)】 ■ Peptide mapping (including amino acid sequence and post-translational modification analysis by LC/MS) ■ Purity, glycan, and charge variant measurement using capillary electrophoresis ■ Charge variant measurement using ion exchange LC and isoelectric focusing capillary electrophoresis ■ Activity (potency) testing through cell assays and ELISA *For more details, please refer to the related links or feel free to contact us.

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