Technical Information Magazine 201911-03 Pharmaceuticals in the Era of Modalities Diversification
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** In recent years, as pharmaceutical modalities such as cell therapies and nucleic acid medicines have rapidly advanced, new methods for quality evaluation that are not present in traditional pharmaceutical quality control are required. Our CMC Analysis Research Department, building on 20 years of experience in the standard testing of small molecules and antibody drugs, has quickly introduced analytical functions required for new pharmaceutical modalities and operates under a GMP framework. This paper presents examples of analytical functions applicable to ADCs, cell therapies, and nucleic acid medicines. **Table of Contents** 1. Introduction 2. Analysis of Aggregates in Human IgG Antibodies by SEC-MALS 3. Analysis of Residual Solvents in Nucleic Acids by GC-MS 4. Cell Analysis by Flow Cytometry 5. DNA Quantification by Quantitative PCR 6. Conclusion
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Technical Information Magazine The TRC News "Quality Evaluation of Pharmaceuticals under GMP Systems in the Era of Diverse Modalities - Cell Products, Nucleic Acid Medicines, ADCs -" [Abstract] Our CMC Analysis Research Department, based on 20 years of experience in standard testing for small molecules and antibody drugs, has quickly adopted analytical functions required for new pharmaceutical modalities and operates under GMP systems. This paper presents examples of analytical functions applicable to ADCs, cell products, and nucleic acid medicines. [Table of Contents] 1. Introduction 2. Analysis of Aggregates of Human IgG Antibodies by SEC-MALS 3. Residual Solvent Analysis in Nucleic Acids by GC-MS 4. Cell Analysis by Flow Cytometry 5. DNA Quantification by Quantitative PCR 6. Conclusion [Figures and Tables] Figures 1 to 12 Quality evaluation items for cell products, nucleic acid medicines, and antibody drugs Calculation of molecular weight and radius of gyration by SEC-MALS, analysis results of aggregates of human IgG antibodies Measurement results of residual dichloromethane in synthetic C-Myc antisense DNA Cell cycle of eukaryotic cells and inhibition by etoposide Analysis results of the distribution of each phase of the cell cycle PCR for DNA derived from CHO cells Threshold cycle number for DNA quantity
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At Toray Research Center, Inc., we provide technical support through analytical techniques and physical property analysis to address various challenges in research and development as well as production fields via contract analysis. Based on our long-standing achievements and extensive experience in analysis and physical property evaluation, we continue to strive to meet the advanced and diverse needs of our customers.
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