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Technical Information Magazine 201910-01 Challenge to Diversifying Modalities

Technical Information Magazine 201910-01 Challenge to Diversifying Modalities

The technical information magazine The TRC News provides the latest information on analytical techniques that are useful for research and development, solving production troubles, and quality control.

**Abstract** With the diversification of drug discovery modalities and changes in healthcare, the required analytical techniques are becoming increasingly sophisticated. At the Toray Research Center, we are engaged in the development of new analytical methods and technologies to support the development of cutting-edge pharmaceuticals and biomarkers. Here, we will introduce analytical case studies related to nucleic acid medicines, antibody drugs/ADCs, and biomarkers/diagnostics. **Table of Contents** 1. Introduction 2. Analysis of Nucleic Acid Medicines 3. Analysis of Protein Medicines 4. Analysis of Biomarkers and Diagnostics 5. Conclusion

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Biopharmaceutical analysis

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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About the establishment of the new organization "Integrated Research Department of Bioanalysis"

About the establishment of the new organization "Integrated Research Department of Bioanalysis"

Regarding the establishment of the new organization "Integrated Research Department of Bioanalysis" - Providing comprehensive analytical support from pharmaceutical research and development to manufacturing.

Our company (hereinafter referred to as "TRC") has established the "Integrated Bioanalysis Research Department" as of April 1st, by consolidating departments responsible for structural analysis, characterization analysis, stability testing, and quality testing, in order to strengthen support for the research and development of diverse biopharmaceuticals represented by antibody drugs, nucleic acid/mRNA drugs, and cell therapies. Traditionally, TRC has provided analytical support at various stages of drug development, including structural analysis and method development to support drug discovery research, pharmacokinetic analysis under GLP conditions, and stability testing under GMP conditions. However, in response to the recent acceleration and diversification of drug development, we determined that an integrated organization of the traditional analytical departments would be effective, leading to the establishment of the new organization. The Integrated Bioanalysis Research Department brings together staff engaged in analysis at all stages of drug development to provide high-quality analytical services to our customers in a seamless manner. This will enhance the sophistication of the ever-evolving analytical technologies for biopharmaceuticals while strengthening our proposal capabilities to customers and aiming for further evolution of our services. Under the fundamental principle of "contributing to society with advanced technology," TRC will continue to grow together with our customers through the analytical expertise and quality cultivated over many years, contributing to the life sciences field, including drug development.

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