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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【Other Main Analytical Functions】 ■ Quantification of aggregates and molecular weight measurement ■ Various protein impurity tests: Residual host-derived protein and residual Protein A tests by ELISA ■ Comprehensive identification of host-derived proteins by two-dimensional LC/MS ■ Quantification of residual DNA by qPCR/ddPCR *For more details, please refer to the related links or feel free to contact us.
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For more details, please refer to the related links or feel free to contact us.
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Our company is a pharmaceutical CMC research and development contract company that spun out from the CMC research division of Takeda Pharmaceutical Company Limited in July 2017. We support excellent pharmaceutical development as experts in CMC research. Our research team consists of experts with extensive experience and achievements in process chemistry, formulation research and development, and analytical testing development related to CMC research. We provide high-level services and solutions tailored to our customers' needs across each process from the early stages of pharmaceutical development to application, while flexibly collaborating. We have established a collaborative system with partner companies, enabling us to offer a one-stop service. Please utilize us as a platform for your pharmaceutical development.